To date, there is no proven treatment for the syndrome, and the mechanisms that cause it are not fully understood.  

Now, a new clinical trial from Keck Medicine of USC is investigating if a diet designed to lower inflammation may play a role in easing this often debilitating condition.  

The premise of the trial revolves around recent research indicating that long COVID may be caused by a hyper inflammatory response that becomes activated during COVID-19 as the body fights off the virus but, in some people, does not recede even after the infection has passed. High inflammation levels in the body can lead to organ damage and other health problems.  

“We are examining if food choice can quiet the body’s inflammatory response and in doing so, effectively minimize or curtail long COVID symptoms,” said Adupa Rao, MD, an investigator of the clinical trial and medical director of the Keck Medicine Covid Recovery Clinic.  

The study will examine the anti-inflammatory effect of a low-carbohydrate diet to lower blood glucose (sugar) levels in combination with a medical food that raises blood ketone levels. Ketones, including beta-hydroxybutyrate, the active ketone in this food, are chemicals the body produces to provide energy when the body is low on carbohydrates and sugars. A low-carb diet and ketones have both been associated with reduced inflammation in the body.  

Researchers plan to enroll 50 long COVID patients being treated by Keck Medicine’s Covid Recovery Clinic. Half the individuals will receive a 30-day dietary intervention and half will not. At the end of the month, researchers will determine how patients tolerated the regimen as well as compare inflammatory markers and long COVID symptoms between the two groups of patients.  

If the nutritional intervention is tolerated well by patients and improves their health issues, researchers plan to expand the clinical trial to a larger population.  

"Research like ours is vital to expand our understanding of long COVID and ultimately help identify effective treatments to improve patients’ quality of life,” said principal investigator of the clinical trial, Nuria Pastor-Soler, MD, PhD, who is also an associate professor of medicine at the Keck School of Medicine of USC. “The results of this trial will hopefully move us closer to potential solutions.” 

Ken Hallows, MD, PhD, a professor of medicine at the Keck School of Medicine, is also a researcher in this study. The clinical trial is funded by the Amy P. Goldman Foundation. 

To learn more about the Keck Medicine Covid Recovery Clinic, please email covidrecovery@med.usc.edu or call 323-442-9209. 

LOS ANGELES — The much-awaited fall COVID-19 vaccine will be available within the next few days. The flu shot is already available, as is a newly approved vaccine for respiratory syncytial virus (RSV), a virus that is especially harmful to infants and older adults.

What can we expect from the vaccines, how important are they and can you get them at the same time? Keck Medicine of USC experts have the answers. 

The new COVID-19 vaccine

The updated COVID-19 vaccine is designed as a single annual dose that targets the Omicron subvariant XBB.1.5 and any XBB substrains. The vaccine is offered by Pfizer and Moderna.

The Centers for Disease Control and Prevention (CDC) recommends that everyone six months and older be vaccinated. 

The CDC is also tracking the rise of a new variant called BA.2.86. Health experts are studying the virus to understand it better, but they still believe the new vaccine is the best way to avoid serious illness, hospitalization and death from all currently circulating COVID-19 variants.

The federal government’s COVID-19 Vaccine Distribution Program, which provided free vaccinations, has ended. However, insurance should pick up the cost of COVID-19 vaccines. For those uninsured or underinsured, the CDC is launching the Bridge Access Program, which partners with state and local programs to provide and distribute free vaccines.  

-- Edward Jones-Lopez, MD, MS, is an infectious disease expert with Keck Medicine of USC. He is available for interviews in English and Spanish.  

Why COVID-19 vaccines are still needed  

Research shows about 75% of Americans have retained at least some immunity from a prior infection of the virus. However, immunity fades over time and the individual risk of getting COVID-19, despite some immunity, is varied and inconsistent. The protection offered by vaccines also diminishes over time.  

Despite advances in treating COVID-19, it still can be a difficult and deadly disease that can lead to hospitalization, long-term symptoms or death. The side effects of the vaccine have proven to be minimal, so it is recommended that everyone who is eligible gets vaccinated, especially as we are coming off an end-of-summer surge and there may be future outbreaks over the holidays.  

If you have any concerns about the vaccine due to a health condition, please consult your health care provider.  

-- Earl Strum, MD, is the medical director of Employee Health Services for Keck Medicine of USC and clinical professor of population and public health science with the Keck School of Medicine of USC.  

Timing your vaccines safely and effectively

It is recommended that everyone six months or older be vaccinated against influenza every year. The best time to get the flu shot is September or October, so you will be inoculated in plenty of time before the high-flu season of the holidays. 

It is safe to get the flu shot at the same time as your COVID-19 vaccine. For some people, one or both vaccines may result in mild flu-like symptoms that should pass within a few days. For those concerned about soreness at the site of the jab, consider getting one shot in one arm and one in the other arm to avoid overtaxing one limb. Also, if a local reaction does occur, you will know which vaccine was responsible. If not insured, you can find a free flu shot at a local health clinic, pharmacy or even grocery store.  

RSV is a highly contagious virus that causes infections of the lungs and breathing passages, particularly among the young and old. The CDC recommends adults 60 years and older receive a single dose of the RSV vaccine in consultation with their health care provider. Additionally, the FDA has approved the RSV vaccine for use in pregnant individuals to protect infants from the virus.  

Clinical trials have shown that there are minimal side effects of the vaccine, and any mild symptoms far offset the possible serious complications RSV can cause. Talk to your health care provider should you have any questions or concerns about this new vaccine, including if you can receive it at the same time as your other vaccines and your payment/insurance options.  

-- Krist Azizian, PharmD, MHA, is the chief pharmacy officer for Keck Medicine of USC. 

How will these developments affect testing, what are the differences between the COVID-19 tests available and when is the best time to test? Krist Azizian, PharmD, MHA, chief pharmacy officer for Keck Medicine of USC, addresses any confusion. 

Every home in the U.S. is now eligible to order four free at-⁠home COVID-⁠19 tests. What types of tests are offered?

These tests are antigen tests. Antigen tests detect a high volume of viral load, and the results are generally available within 15 minutes. You can order the free at-home tests here.

How will these free tests change testing?

Allocating four at-home tests per household will make testing more accessible. If your household requires more than four tests, you may be eligible to be fully reimbursed for tests you purchase or get them free of charge through an insurance reimbursement program that launched Jan. 15. You can contact your health insurance provider for further information.

Additionally, the government also has created an online resource to help Americans find local low or no-cost testing. While manufacturers are working hard to keep up with the demand for at-home tests, it will probably take a few more months for them to get totally up to speed.  

How do you know which at-home test to get? There are so many on the market.

The U.S. Food and Drug Administration has authorized the emergency use of several different brands of at-home tests, and you should choose from one of these. You can find the list here.

If a family needs more home tests but can’t find them, is it okay for more than one person to share a test – both use the same swab?

Absolutely not. These tests are for single application only. People are taking a tremendous risk of exposing others by using one swab for multiple family members. If one has COVID-19 and the others don’t, sharing a swab almost guarantees everyone will get it.

Labs and clinics also offer antigen testing. Are lab or clinic tests better or more accurate than over-the-counter, at-home tests?

Not necessarily. Antigen tests conducted at a clinic or lab are very likely comparable to tests purchased over the counter. The only reason lab testing may be more accurate is because some people may use the at-home tests incorrectly or may misinterpret the results.  

How is a PCR test different from an antigen test?

PCR tests are generally analyzed in a lab and are considered the gold standard for diagnosing COVID-19. Testing results usually take a few days unless you get a rapid PCR test, which allows you to learn the results in a few hours. The tests are much more sensitive than antigen tests, meaning they can detect a lower viral load than an antigen test. They are also less likely to produce inaccurate results, both negative and positive.

Is it possible to find free PCR tests?

Some workplaces and schools offer free PCR tests, and some health insurance providers reimburse PCR tests ordered by your health care provider. You may also find local sites or pharmacies that offer free PCR testing. For example, Los Angeles County offers free at-home PCR tests that people can pick up and return for lab analysis.  

What is the timeline for getting tested if someone is exposed to COVID-19?

COVID-19 has an incubation period of five to seven days, so you should get tested at least five days after exposure or upon the onset of symptoms.

Which type of test is best after exposure?

If you are asymptomatic, a PCR test is your best option because it detects COVID-19 at a much lower viral load. In general, viral load correlates to symptoms. If you are asymptomatic, your viral load may be too low to be detected by an antigen test. (Please note, however, that even if you are asymptomatic, you may still be contagious.)

If you have symptoms, you can take either an antigen test or a PCR test because symptoms generally mean your viral load is higher, which both tests should detect. If you test negative on an antigen test, for greater reassurance, follow up with another antigen test at least 24 hours later or a PCR test.

While antigen tests are fairly accurate in detecting positive results, if you test positive on an antigen test, it’s best to follow up with a PCR test. However, you should quarantine upon receiving a positive result from any test.

Some workplaces are recommending a negative antigen test within five to 10 days of testing positive or after symptom onset (as long as symptoms are resolving) to allow employees to return to work. The rationale for this is that a negative antigen test, along with symptom resolution, indicates a low viral load with minimal chance for transmission. 

What is the biggest testing mistake you see?

The biggest testing mistake I see is people taking tests too soon before the viral load can be detected. Testing too soon can waste at-home tests, cause people to needlessly spend money on lab tests and give them a false sense of assurance should they test negative. Testing is a very effective tool for detecting COVID-19; however, it’s best to wait at least five days after exposure to test.

Are N95s right for everyone? What is the difference between an N95 and a KN95 mask? Are surgical masks and cloth masks worth wearing at all? Is double masking really effective?  Edward Jones-Lopez, MD, MS, an infectious disease specialist with Keck Medicine of USC and an expert on the transmission of airborne pathogens, answers these and other pressing questions.  

Why are N95s the gold standard in masks?

N95 masks, also known as N95 respirators, are tested and approved by the National Institute for Occupational Safety and Health (NIOSH). They filter out at least 95% of airborne particles, including very small ones known as aerosols that are undetectable by the human eye.

With early COVID-19 variants, most of the virus transmission was through larger respiratory droplets (10-100 microns in size), but the omicron variant is highly transmissible, and therefore more likely to be primarily transmitted through aerosols (5 microns or smaller in size). The N95 is the only mask available proven to filter out aerosols.

Are N95s for everyone?

When the pandemic first started, public health officials were worried that they would run out of masks, including N95s. There are now enough N95 masks for more widespread distribution.

To be effective, N95 masks must be fitted on the face so they form an airtight seal around the mouth and nose. There are many different styles to choose from, such as ones shaped in a cone or duckbill, and it can be hard to know which one fits you best and how to properly put it on and take it off.

N95 masks can be uncomfortable to wear, and some people can’t tolerate them for long or may take them on and off frequently, which undercuts their effectiveness. N95s are also more expensive than other types of masks. This can make them inaccessible for widespread use, as they need to be replaced frequently and must be kept clean, dry and retain their shape to remain effective.

In general, N95s are best used in special circumstances, such as for people who are immunocompromised and at increased risk for severe infection, traveling for long periods of time on crowded public transportation or out in public unvaccinated.

What are KN95 masks?

KN95s are designed and tested to meet international standards. The U.S. Food and Drug Administration allowed emergency use of KN95s when N95s were hard to find, but this usage was revoked once N95s were in greater supply.

KN95s offer very good protection, but less than N95s. They lack NIOSH testing and approval and do not provide the same airtight seal that N95s do. They are still the next best option to N95s, especially as many people will tolerate wearing them better than N95s and are less likely to take them on and off for comfort.

How effective are surgical and cloth masks?  

Surgical masks offer the next best level of protection, even though they drop down considerably in effectively blocking out smaller particles such as aerosols. It is a good idea to double up on surgical masks. Double masking minimizes gaps around the sides of the face or nose, creating a more secure fit, and doubles the thickness of the mask. The denser the mask is, the more effective it will be filtering out particles.

While cloth masks can effectively block large respiratory droplets, they have proven to be ineffective blocking smaller particles such as small droplets and aerosols, and are not recommended for protection against the omicron variant. However, I do want to remind people that in a pinch, any mask is better than none at all.

Keck Hospital of USC performs some 300 liver and kidney transplants each year, and provides ongoing care to thousands of post-transplant patients on an outpatient basis. During the peak of the COVID-19 surge in Los Angeles, Keck Medicine of USC physicians implemented a new protocol to monitor and manage the care of liver and kidney transplant recipients who developed COVID-19, including monoclonal antibody therapy for eligible patients.

Now, a new study shows that as a result of these efforts, the number of hospitalizations and deaths for patients managed with the new protocol dropped by 18%. For those who received the drug therapy, the number of hospitalizations were halved, and deaths reduced to zero.

“We took a very proactive approach in managing our at-risk patients that resulted in significantly improved outcomes,” said Aaron Ahearn, MD, PhD, a liver, kidney and pancreas transplant surgeon with Keck Medicine, who also is the principal investigator and corresponding author of the study.

Quick response to an urgent problem

Early in the pandemic, Keck Medicine physicians realized that COVID-19 was much more lethal for transplant recipients than the general population. By December 2020, the height of the Los Angeles outbreak, they were treating 20 or more COVID-positive liver or kidney transplant recipients per week, many of them gravely ill.

“We were overwhelmed with cases and realized we needed to do something quickly to help these patients,” said Ahearn.

Ahearn and his colleagues assembled a multidisciplinary team consisting of transplant, infectious disease, nephrology, hepatology and family medicine specialists to devise a new patient protocol that included:

• Creating a database to track COVID-19 outcomes.
• Educating staff on identifying and monitoring COVID-19 symptoms.
• Creating a triage system to determine the severity of the disease and appropriate level of care.
• Providing telehealth visits by internal and family medicine doctors.
• Giving all recent transplant recipients a home pulse oximetry monitor to track their oxygen levels.

Additionally, eligible patients who tested positive for COVID-19 were offered monoclonal antibody therapy, which the U.S. Food and Drug Administration had approved in November 2020 for emergency use to treat COVID-19. Monoclonal antibodies have been found to be effective for treating mild to moderate COVID-19 disease soon after infection.

Patients who tested positive for COVID-19 within the previous 10 days with symptoms not severe enough to be hospitalized were eligible for the drug therapy. All patients who met this criterion were offered a single outpatient infusion of one of two monoclonal antibody therapies.

How the study was conducted

For the study, the physicians conducted a retrospective review of all liver and kidney transplant recipients who tested positive for COVID-19 and were seen at Keck Hospital from Feb. 1, 2020 to Feb. 28, 2021, a total of 226 patients. They reviewed patient demographics, COVID-19 treatments, hospitalizations and survival rates.

When comparing the outcomes of all patients before and after the protocol was implemented, the study authors found the total rate of hospitalization dropped from 54% to 35% and deaths from 20% to 9%.

They also discovered that the protocol was even more effective for patients who were identified early in their disease course and were therefore eligible for monoclonal antibody therapy.

A total of 34 (17 liver or combined liver/kidney transplant recipients and 17 kidney transplant recipients) received the drug therapy. For this group, COVID-related hospitalizations fell from 32% to 15% and death from 13% to zero.

Additionally, none of the patients had a major adverse reaction to the therapies.

Ahearn believes these results have important implications for the continued treatment of liver and kidney transplant recipients in the age of COVID-19.

“While all patients benefitted from our change in protocol, those who received the monoclonal antibodies benefitted the most,” he said. “Our study strongly suggests that these therapies can reduce disease progression in liver and kidney transplant recipients with COVID-19 and should be considered for all patients.”

Other authors in the study include Thin Thin Maw, MD, a nephrologist with Keck Medicine; Rishi Mehta, MD, a clinical assistant professor of medicine (clinician educator) at the Keck School of Medicine of USC and the associate medical director of inpatient operations at the Keck School; Juliet Emamaullee, MD, PhD, a transplant surgeon with Keck Medicine; Jim Kim, MD, a kidney and pancreas transplant surgeon with Keck Medicine; Emily Blodget, MD, MPH, an infectious disease specialist with Keck Medicine; Jeffrey Kahn, MD, a hepatologist with Keck Medicine; Linda Sher, MD, a hepatobiliary and pancreatic surgeon with Keck Medicine; and Yuri Genyk, MD, a hepatobiliary and pancreatic surgeon with Keck Medicine and division chief of hepatobiliary, pancreas and abdominal transplant surgery at the Keck School.

We are seeing reports that COVID-19 cases among pregnant women are increasing. Is there a specific reason for this increase?

The COVID-19 cases among pregnant women are climbing due to the delta variant, which is much more transmissible than other virus strains.

Why is it important that pregnant women get the COVID-19 vaccine?

There are several reasons why pregnant women should receive the COVID-19 vaccine, including:

• Greater risk of severe COVID-19 if they contract the virus.
• Higher death rate if they get the coronavirus.
• Increased risk of pre-term birth of the baby.
• Chance of health risks to the fetus.

This is why not only the CDC but also the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine recommend that pregnant women be fully vaccinated, whether with the Pfizer, Moderna or Johnson & Johnson vaccine.

Why are pregnant women more at risk for severe COVID-19?

During pregnancy, the body’s immune system is suppressed, leaving pregnant women more vulnerable to all viral illnesses, including COVID-19. In addition, pregnancy hormones and the growing fetus can decrease the ability of the lungs to expand so a respiratory illness such as COVID-19 can be more dangerous.

Is it safe for pregnant women to get the vaccine?

The COVID-19 vaccine is safe. There has been no evidence that the vaccine will harm either the pregnant woman or the baby in the womb. In my practice, I see women who are hesitant to get the vaccine, but I encourage them to get it and provide as much data and reassurance to help them feel comfortable and educated when they make their decision.

Additionally, with the recent news that the Biden administration has recommended that Americans receive a booster vaccine eight months after their second shot of the Pfizer or Moderna vaccine, women who are pregnant eight months after being vaccinated may need a booster shot.

Is there a best time in the pregnancy for women to get vaccinated?

It is advisable to get vaccinated early in the pregnancy for maximum protection against COVID-19, but it is safe and recommended to get vaccinated at any time during pregnancy. Women should be mindful that they may have a few mild flu-like symptoms after receiving a vaccine, but these symptoms typically disappear within 48 hours. They should consult their obstetrician and gynecologist if they experience severe and/or prolonged symptoms. It is also recommended that women trying to get pregnant get the vaccine so they enter into pregnancy protected.

Does the vaccine affect fertility?

There is no research showing that COVID-19 vaccines affect a woman’s fertility, or for that matter, a man’s fertility. Receiving the vaccine will not impede family planning.

Can getting vaccinated while pregnant pass down immunity to the unborn child?

The antibodies created by the vaccine to protect the mother have been found in umbilical cord blood, which means that the COVID-19 vaccination during pregnancy might help protect babies against COVID-19. More research, however, needs to be done to determine the extent of this possible protection. 

Should breastfeeding moms get vaccinated too?

The CDC has also recommended that breastfeeding mothers get vaccinated. Yet, breastfeeding mothers, just like pregnant women, have lower COVID-19 vaccination rates in comparison to other non-pregnant patient populations. In addition, there is data that nursing mothers who receive a COVID-19 vaccine may pass protective antibodies to their babies through breast milk for at least 80 days following vaccination.

The rise of the delta variant and why it’s so important to get vaccinated

“People are understandably concerned about the recent rise in COVID-19 cases and hospitalizations, largely due to the more contagious delta variant, which now accounts for most cases in the United States. Research shows that patients with the delta variant carry up to 1,000 times more virus in their nasal passages than patients infected with the original strain.

“Over 99% of people hospitalized or dying from COVID-19 are unvaccinated. This is why it is so important to get vaccinated. While not foolproof, COVID-19 vaccines are highly effective in preventing COVID-19 infection hospitalization and death. Breakthrough infections — when people who are fully vaccinated test positive for the disease — are rare and tend to be moderate with less chance of hospitalization or death. Until more of the country becomes vaccinated, we will continue to see cases and hospitalizations rise.”

• Edward Jones-Lopez, MD, MS, infectious disease expert with Keck Medicine of USC

The possibility of breakthrough infections leading to long COVID

“COVID-19 affects multiple organs, and some 10 or more percent of those who have had the virus will experience long-term symptoms including fatigue, brain fog, breathlessness, aches, cough, diarrhea, dizziness, anxiety and depression. That is why we developed a Keck Medicine COVID Recovery Clinic that unites a multidisciplinary team of experts, including behavioral health specialists, cardiologists, neurologists, rheumatologists, pulmonologists, pharmacists and occupational therapists. We are also encouraged that long-haulers may have access to disability protection in the future, which will support their long-term recovery.

“Those who have had an extended and severe COVID-19 illness tend to be more at risk for developing long-term symptoms. So far it appears that those who experience a breakthrough COVID-19 infection will avoid this prolonged recovery because breakthrough infections tend to be milder and shorter in duration. It is still possible that some immunized patients could have long-term symptoms, and we will continue to watch for that development.”

• Purush (Adupa) Rao, MD, pulmonologist with Keck Medicine of USC

How to cope with anger related to increased COVID-19 risks and new mask mandates

“Earlier this year, society felt a collective anger when vaccine access was limited because some felt the distribution was unequal or random. By early July, as vaccines became freely available in the United States, anger was replaced with the hope that COVID-19 was moving into the rearview mirror. However, now with the recent rises in cases and hospitalizations, primarily among those who are unvaccinated, some people may be angry at those who are unvaccinated because of the increased risk of catching the virus and the new mask mandates. They may feel that they did everything that was asked of them to protect themselves and those around them, but others didn’t.

“To cope with anger, it may help to consider that those who are unvaccinated are not guided by malice or disregard for others, but by their belief systems and, in some cases, lack of information or misinformation. We didn’t get to this place overnight, and we won’t get out of it without working together to foster a sense that everyone matters, even when they act in ways that seem to place us in harm’s way.”

• Steven Siegel, MD, PhD, chief mental health and wellness officer and psychiatrist with Keck Medicine of USC and chair of the Department of Psychiatry and the Behavioral Sciences at the Keck School of Medicine of USC

On the trend toward the government requiring employees and health care workers to show proof of vaccination or face frequent testing

“In California, we have just learned that state and health care employees must get the COVID-19 vaccine or face frequent testing. The state of New York and the U.S. Department of Veterans Affairs are enacting similar vaccine requirements as are many leading health systems across the country. Keck Medicine welcomes this announcement, and it is very much in line with a policy we have in development as we believe vaccination is one of the key tools to keep staff and patients safe. Currently, 84% of Keck Medicine hospital staff and 87% of physicians are vaccinated. With the upcoming state mandate and policy, the health system expects to reach 90%.

“Moving forward, Keck Medicine is considering only allowing approved religious and medical exemptions, eliminating a current blanket declination for personal reasons. The state-level decision will give us and other hospitals more public support to mandate vaccines, allowing us to better protect our patients and communities.”

• Felipe Osorno, executive administrator, continuum of care operations and value improvement, Keck Medicine of USC

“We’ve seen how important it is to offer our faculty and staff resources to keep them safe and healthy, and we want to continue to assist them as we enter into a new phase of the pandemic,” said Tammy Capretta, RN, MPH, chief transformation and risk officer for Keck Medicine. “The expansion of our employee wellness program will help us give back to our work force as they provide exceptional care to our patients.”

Keck Kindness and other employee initiatives

One new Care for the Caregiver initiative is the Keck Kindness program, which offers employees financial support to help with an immediate monetary need. “We know that many peoples’ financial situations have changed due to the pandemic and we want to help, whether it’s an assist with a car repair or other unexpected expenses,” said Capretta.

The program is also adding peer mentoring, resiliency training and grand rounds-style events that focus on the emotional impact of patient care, as well as other services to build both community and emotional health across the health system.

Appointment of Steven Siegel, MD, PhD, as chief mental health and wellness officer

In another program expansion, Keck Medicine has appointed Steven Siegel, MD, PhD, as chief mental health and wellness officer.

In this role, Siegel, who will also retain his position as chair of the Department of Psychiatry and Behavioral Sciences at the Keck School of Medicine of USC, is responsible for overseeing and coordinating all mental health services for both patients and employees throughout the health system. He will supervise a staff of trained counselors to help employees with emotional well-being.

“This new position moves Keck Medicine forward as a leader in integrated mental health, and it’s an honor to be part of this significant investment in patient and staff well-being,” said Siegel.

Jonathan Wong, PsyD, a clinical psychologist with Keck Medicine and clinical assistant professor of psychiatry and the behavioral sciences at the Keck School, will serve as clinical director of the program and is responsible for programmatic development and employee care.

In addition, the program will collaborate with other entities, such as the USC Center for Work and Family Life, to provide extra support as needed.

“The success of our Care for the Caregiver program underscores the importance of mental health support, as well as our collective strength when we care for one another,” said Siegel. “We are very excited to make our employee wellness program sustainable and permanent and look forward to continuing to evolve along with the needs of our faculty and staff.”

Don’t ditch your mask at the doctor’s office

“On June 15, people who are fully vaccinated will no longer be required to wear masks, with a few exceptions, however. One of those is in health care settings. According to guidelines from the state and the Centers for Disease Control, everyone, regardless of their vaccination status, must continue to wear a mask in a doctor’s office, clinic or hospital.

“At all Keck Medicine hospitals and outpatient offices, we are still requiring individuals to wear masks at all times and maintain six feet of physical distance from others. We will continue to screen for COVID-19 symptoms for all our patients and visitors upon entry. Patients in our hospitals will now be allowed two visitors at a time if both visitors are vaccinated or one visitor if that visitor is not vaccinated. Overnight visitors, however, must be vaccinated.

“While such measures may seem restrictive in the new relaxed environment, we, as health care providers, owe it to our patients, visitors and staff, some who are among the most vulnerable and prone to catching the coronavirus, to continue to take all precautions to protect them from COVID-19. We and other health care providers will continue to evaluate best safety policies throughout the summer as we receive further guidance from state and national public health officials.”

-- Stephanie Hall, MD, chief medical officer of Keck Hospital of USC and USC Norris Cancer Hospital

The possibility of breakthrough infections is low, even with the rise of the Delta variant

“Vaccines, while not foolproof, are highly effective in preventing COVID-19, hospitalization and death. We are seeing a few cases of people who are fully vaccinated testing positive for COVID-19, which is also called a breakthrough infection. However, the chances of that happening are extremely low, way below one percent. Breakthrough cases also tend to be moderate.

“The rare breakthrough infection can happen in two instances. It most commonly occurs when someone is exposed to a variant of the coronavirus, such as the Delta variant prevalent in India, and the vaccine fails to protect against the new strain of the virus. Additionally, a small segment of the population, which includes the elderly or immunosuppressed, is unable to mount a strong enough immune response to the virus, leaving them vulnerable to future infections.

“We are currently seeing a rise in the Delta and other variants in the United States, but data is showing that the vaccine, whether it’s the Pfizer, Moderna or Johnson & Johnson vaccine, protects against variants. We expect breakthrough infections to remain isolated cases even as the state opens up. For the vast majority of those vaccinated, they can rest assured that the vaccine will protect them.”

-- Edward Jones-Lopez, MD, MS, infectious disease expert with Keck Medicine of USC

Expect to keep visiting your doctor virtually

“The pandemic has seen a phenomenal rise in telehealth – patients accessing their doctors online. Keck Medicine telemedicine visits have increased roughly from 10 per day pre-COVID-19 to approximately 800 a day. To date, we have seen more than 75,000 unique patients, resulting in more than 223,000 telehealth visits. In addition, we have increased accessibility to services as a result of telehealth, including psychiatry, neurology, primary care and several medical specialties. 

“Telemedicine, however, has a much longer shelf life than the pandemic. According to one internal survey, patient satisfaction with the quality of service ranked in the 99th percentile. Telehealth offers patients flexibility and convenience in how and where they receive their health care, and could have a long-term impact on increasing access to care. This is a positive change for the industry for both patients and providers. While the number of telehealth appointments may decline as people return to in-person visits, remote access to physicians is here to stay. “

-- Smitha Ravipudi, MPH, CEO of USC Care and Ambulatory Care Services with Keck Medicine of USC

The effect of shootings and other acts of violence on mental health

“The mass shootings in recent weeks have the potential to place our fears, despair and anger at the forefront of our minds. This often leads to a need to cope with the devastating news. Without a solution, we may enter a state of internal struggle as we grapple with the unknown and the loss of a desired sense of control. For many, this produces the same uneasy feeling that has been unfolding throughout the COVID-19 pandemic’s ups and downs and can impact peoples’ mental and physical health.”

-Jonathan Wong, PsyD, clinical psychologist, Keck Medicine of USC

How added trauma may affect peoples’ willingness to reenter society, and how to reduce fears and anxiety

“People may feel hesitant to return to their normal activities because the world feels like a dangerous place. However, they may feel reassured to realize that vaccines, masks and other COVID-19 countermeasures are safe and effective in reducing risk of infection. As for acts of mass violence, it may help to accept there is an inherent risk in everything we do, but we should try to not let this stop us from living fully.

“Some people are more demoralized than depressed, meaning that they feel unable to cope. If you are demoralized by COVID-19 or recent disturbing events, think of one thing you would enjoy or that you would like to accomplish. Then do it. The immediate sense of joy and satisfaction you experience will help balance any negative feelings. Another technique is to literally try to leave anxiety 'at the door.' As you exit a room, building, or even a Zoom call, tell yourself, you will put any worries behind you. The physical act of leaving can serve as an end point for stressful ruminations and reset your mental energies. I also recommend that people see a therapist or seek medical care when they experience a prolonged period of depression.”

-Steven Siegel, MD, PhD, psychiatrist, Keck Medicine of USC; chair of the Department of Psychiatry and the Behavioral Sciences, Keck School of Medicine of USC

Symptoms of stress to look out for and lifestyle changes to combat them

“We see more patients presenting with stress-related symptoms stemming from fears of going outside and/or of COVID-19 infection and deep concern about recently reported traumatic events like shootings and acts of violence. Stress can manifest in the body as loss of sleep or frequent waking in the night, abdominal pain, diarrhea, heart racing, racing thoughts, dizziness, sweating or unexplained fear of certain situations. Fearful episodes can be triggered by daily, seemingly routine tasks, such as visiting the grocery store.

“Toxic stress can be just as damaging as other physical ailments so it is important to take time to practice self-care by turning off the phone and limiting exposure to social media/media that may bring traumatic images to mind. Also take time to eat well, exercise and get at least eight hours of sleep. In addition, there are a number of meditation apps that can help people recenter and find peace, even if used for only for 10 minutes per day.”

-Anjali Mahoney, MD, MPH, family medicine physician, Keck Medicine of USC

Alcohol and tobacco sales nationwide rose in the early months of COVID-19, according to a study appearing in the Annals of Internal Medicine today. From April – June 2020, researchers found that sales of these substances increased 34% and 13% respectively when compared to the same months in 2019.

“These are significant jumps, and show that the stress, boredom and loneliness caused by the pandemic may have led to increased alcohol and tobacco use,” said Brian P. Lee, MD, MAS, a hepatologist and liver transplant specialist with Keck Medicine and the USC Institute for Addiction Science, and lead author of the study.

Tobacco and alcohol abuse are the second and ninth largest contributors to global deaths, causing some eight million deaths each year worldwide.

Lee and his colleagues decided to study alcohol and tobacco purchasing patterns after noticing that in 2020, Keck Hospital of USC admissions for alcohol-associated liver disease (cirrhosis or alcoholic hepatitis) were up approximately 30% compared to the year before. Some patients also admitted to using alcohol to handle pandemic-related stressors.

The doctors wondered if the trend they were witnessing locally was also happening nationally. And if one substance was being abused, they wondered if a second — tobacco — might be as well.

Seeking national data, they turned to the Nielsen National Consumer Panel, which tracks the spending habits of approximately 70,000 households in the United States over time and is designed to be nationally representative. People are given a handheld scanner or use a smart-phone app to scan products at stores to report their purchases.

Researchers compared alcohol and tobacco sales between the months of April – June in 2020 with the same time period in 2019. They set up controls to offset extenuating factors, such as restaurants and bars being closed during these months, which could independently cause an uptick in alcohol sales.

When they calculated their results, they found that from 2019 to 2020, tobacco sales increased in households across all demographics and alcohol sales increased across nearly all demographics as well. Sales increases for both substances were the highest, however, among younger adults, ethnic minorities, those with younger children and/or large families and those with higher incomes.

“We hypothesized that these subgroups, such as those with younger children, were buying more alcohol and tobacco because they felt more stressed than other segments of the population,” said Lee, who is also an assistant professor of clinical medicine at the Keck School of Medicine of USC. “For those with a higher income, sales might have increased simply because they have greater disposable income,” he added.

The data also revealed that sales of hard liquor increased more than wine and beer, a result Lee found troubling. “Liquor has the highest alcohol content and could be a sign of problem drinking,” he said.

Lee believes that the study may reveal a previously unrecognized COVID-19-related public health issue. “This study draws attention to the fact that many people across the country might be self-medicating as a way to cope,” he said. “By spotlighting this issue, individuals can identify this behavior as potentially harmful and substitute drinking or smoking with healthier activities. Mental health professionals and medical institutions, in addition to policymakers, can also develop interventions to help them.”

Other Keck Medicine physicians involved in the study are Norah Terrault, MD, a Keck Medicine gastroenterologist and chief of Gastroenterology and Liver Diseases at the Keck School; Jennifer Dodge, MPH, an assistant professor of research medicine and preventive medicine at the Keck School; and Adam Leventhal, PhD, a professor of preventive medicine at the Keck School.

The researchers hope to conduct further studies to see if this three-month trend has sustained throughout the pandemic.

What physicians have learned about COVID-19 and its effect on the heart

“Those with cardiovascular risk factors, from hypertension or high cholesterol to more sophisticated presentations such as coronary artery disease or heart valve problems, are at a higher risk of complications from COVID-19. This is because the SARS-CoV-2 virus tacks on a respiratory illness to an already taxed cardiovascular system.

“For some patients, even those without a prior heart condition, COVID-19 can cause blood clots to form in the lungs, known as pulmonary embolisms, which block the flow of oxygen to the lungs and can damage the heart. In addition, the body’s aggressive inflammatory reaction to the virus, where the immune system floods the bloodstream with inflammatory molecules called cytokines, can lead to serious cardiac issues, including heart failure and death.

“Another way the pandemic has affected heart health is that many patients are deferring care when they have life-threatening heart issues. Hospitals and clinics are very safe, with multiple precautions in place to protect patients from possible COVID-19 infection. We urge people to seek medical attention at the first sign of a heart problem.”

— Craig Baker, MD, is a cardiac surgeon with Keck Medicine and chief of the Division of Cardiac Surgery at the Keck School of Medicine of USC.

Special considerations for women’s heart health

“Although some may think of heart disease as a man’s disease, cardiovascular disease claims the lives of one in three women, with African American and Hispanic women at especially high risk of having undiagnosed cardiovascular disease.

“During the pandemic, one thing we are noticing is that women in particular are forgoing self-care because they are taking care of their immediate and extended families — working from home, overseeing virtual learning for their children and constantly multi-tasking to maintain their family's safety and well-being during these unprecedented times. They may ignore or delay care for heart-related issues because they aren’t aware that heart disease can present differently in women than men.

“For example, when women have a heart attack, they are more likely to present with symptoms such as neck or jaw pain, shoulder, upper back or abdominal discomfort, shortness of breath, vomiting or unusual fatigue rather than the typically expected chest pain or angina. We continue to urge women to be attuned to their bodies and make their health care as much of a priority as everyone else’s in their lives.”

 — Vivian Mo, MD, is a cardiologist with Keck Medicine and director of the USC Women’s Cardiovascular Center. She serves as interim chief of the Division of Cardiology and as chief medical officer of the USC Care Medical Group. 

How COVID-19 is affecting cardiac surgery

“We seriously weigh the risks and benefits of proceeding with treatment of patients with heart disease during the pandemic. For some patients, such as those needing valve or coronary artery surgery, it’s important to move forward because we feel these patients will be in a better position to withstand COVID-19 after surgery should they become infected.

“If a patient with heart disease is COVID-19-positive, in general, we would wait to do surgery until the patient is COVID-free, unless we determine the surgery is lifesaving. As long as physicians are in communication with their patients and monitoring them regularly, many patients can safely wait for surgery until their COVID-19 is resolved.”

— Vaughn Starnes, MD, is a cardiac surgeon with Keck Medicine and surgeon-in-chief at USC Norris Cancer Hospital and Keck Hospital of USC. He is also chair of the Department of Surgery at the Keck School.

Steps patients with heart issues can take to protect their health during the pandemic

“The main question we get from patients is, should I continue to take my heart medications, such as aspirin or blood pressure or cholesterol medication. The answer is yes. These drugs not only treat heart disease, which is a major risk factor for severe COVID-19 illness, but research also shows they may be beneficial should a patient come down with COVID-19. If patients have any questions or concerns, they should consult their physician. Telehealth has made it especially easy to touch base with doctors.

“Given patients’ high-risk status, we also advise them to follow all COVID-19 public health recommendations such as mask wearing and physical distancing. And when they are offered the vaccine, they should take it as soon as possible.”

— Ajay S. Vaidya, MD, is a heart failure cardiologist with Keck Medicine specializing in heart transplants and an assistant professor of clinical medicine at the Keck School.

The unique risk COVID-19 poses for people with diabetes

“Diabetes does not necessarily make you more likely to contract COVID-19 but does increase the risk of becoming severely ill or dying from complications. Patients with both Type 1 and Type 2 diabetes have hyperglycemia, which means their glucose (blood sugar) levels are high. High blood sugar levels can impair a person’s ability to fight off infection, such as the SARS-CoV-2 virus that causes COVID-19. People with diabetes also have more inflammation throughout their body, which can impair organ function. COVID-19 is also associated with inflammation, so having both diabetes and the coronavirus can be dangerous.

“The majority of people with Type 2 diabetes are also overweight or obese, and obesity has been found to be another risk factor for severe COVID-19. Type 1 diabetes, however, is not usually connected with being overweight, so these patients typically do not share this secondary risk.”

— Katie Page, MD, is a diabetes specialist with Keck Medicine and an associate professor of medicine and co-director of the Diabetes and Obesity Research Institute at the Keck School of Medicine of USC.

Preventive steps people with diabetes can take to protect their health if they get COVID-19

“Data shows that people with diabetes who have COVID-19 have better outcomes if they have more normal blood sugar levels. One way to control blood sugar levels is through diet and exercise. Patients with both Type 1 and Type 2 diabetes should follow a healthy diet (more fresh fruits and vegetables and less refined carbohydrates) and get at least 30 minutes of aerobic exercise five times a week. One exercise session can lower blood sugar levels for up to 36 hours afterward. Over time, a healthy diet and regular exercise can also lead to weight loss, which also lowers glucose levels. In addition, it’s important that people with diabetes stay on top of their medication regimens during the pandemic.

“This advice is especially critical for Latinos who, in Los Angeles County, are nearly twice as likely as non-Hispanic whites to have diabetes and who make up 73% of all hospitalized COVID-19 patients.

“However, my message to everyone with diabetes is the same: You can make a difference in your health. The better you control your diabetes, the greater your chance of having better outcomes should you contract COVID-19.”

— Anne Peters, MD, is director of the USC clinical diabetes programs and a professor of medicine (clinical scholar) at the Keck School.

COVID-19 treatments for people with diabetes and the possibility of a COVID-19-induced diabetes

“We have not yet seen any COVID-19 treatment to be specifically beneficial for patients with diabetes. However, diabetes may affect the risk and benefits of a treatment. For example, steroids, which are used to treat some COVID-19 patients, can cause blood sugar levels to rise sharply, particularly in someone with diabetes. So, the possible benefits of using this therapy for a COVID-19 patient with diabetes may be outweighed by the risk.

“Interestingly, we are also seeing what some might call COVID-19-induced diabetes. In one study, hyperglycemia occurred in 14.3% of hospitalized COVID-19 patients who did not have preexisting diabetes. COVID-19 patients with hyperglycemia are often given insulin to lower their blood sugar levels. In some cases, a patient may continue to have hyperglycemia after recovering from COVID-19. In general, however, COVID-19-induced high blood sugar should not be a permanent condition once the patient has healed unless the person had undiagnosed diabetes before contracting the coronavirus. More research will need to be done to fully understand this phenomenon.”

— Trevor Angell, MD, is a diabetes, endocrinology and metabolism specialist with Keck Medicine and an assistant professor of clinical medicine at the Keck School.

How the pandemic is affecting foot ulcers, one of the most common and dangerous side effects of diabetes

“Half of all people with diabetes will develop diabetic neuropathy, which causes numbness as a result of dying nerves, usually in the feet. With this condition, people may develop a foot sore without knowing it. If the wound becomes infected, this may result in the foot having to be amputated. In fact, there is an amputation around the world every 20 seconds due to foot ulcers caused by diabetes.

“During the pandemic, we are urging patients to seek regular checkups because foot sores can creep up silently and quickly. The Keck Medicine wound healing and limb preservation team sees patients in-person or through virtual visits and asks them to send foot selfies so we can track and treat any wounds. A recent study showed that telemedicine is just as effective as office visits in stopping diabetes-caused foot infections. In fact, telemedicine has worked so well for Keck Medicine that we have actually seen a downturn in hospitalizations for foot ulcers during the pandemic.”

— David G. Armstrong, DPM, PhD, is a surgical wound care specialist with Keck Medicine and a professor of clinical surgery at the Keck School.

Q. How can people gather together safely for Thanksgiving?

A. The safest way to enjoy the holiday is to celebrate only with your household — those you have been interacting with regularly on a daily basis. If you want to extend the gathering to other people, the only no-risk way is to host a virtual celebration. If you do have an in-person gathering, make it small, no more than two households, ideally those in your “pod” you have already been interacting with. However, any celebration beyond a virtual one adds some component of risk, especially if older adults or those with a preexisting condition will be attending. Everyone needs to evaluate their comfort level of this risk.

Q. If you decide to host a small gathering, how can you make it as safe as possible?

A. The transmission rate of the coronavirus is 19 times less when you are outside than inside, so outside gatherings are preferable. You will still need to wear masks (when not eating or drinking) and stay socially distant by at least six feet from others because we have seen a few super spreader events that were held outside.

If being outside is not an option, opening windows and doors and running fans to enhance the air circulation may lessen the possible spread of infection. Being in an enclosed area without ventilation is the riskiest scenario.

Q. What about sharing food? How can this be done responsibly?

A. When we share food, we are at risk for indirect, not direct, transmission. Staying safe is doable if everyone has their own dedicated utensils and plates. When serving yourselves, wear masks and remember to stay six feet away from each other.

Q. What precautions should be taken if a person is coming to Thanksgiving from out of the area?

A. The Centers for Disease Control and Prevention has recommended that no one travel for Thanksgiving. Anyone who still wishes to travel should quarantine for as many days as possible (14 is preferable). They should also get a COVID-19 test, as should everyone in your household, before the visit. However, it’s important to know that COVID-19 tests are not 100 percent accurate and only reflect one point in time. It is possible to test negative and still have the disease.

Q. How safe is flying right now if you are traveling for the holiday?

A. Studies are showing that air travel is relatively safe, with few cases of transmission due to planes’ advanced filtration systems that replace the air in the cabin every few minutes. Just make sure you check any travel restrictions before you fly.

Your behavior on the plane plays a role, however. When flying, wear your mask at all times (unless taking it off briefly to eat or drink) and preferably also wear a face shield since we now know the coronavirus can enter through the eyes. Disinfect all areas of your seat, especially the tray table, where bacteria are known to collect. Also turn on the air nozzle above the seat and point it directly at your face to increase air circulation.

It is appearing that the main risk in flying is transportation to and from the airport if you are dependent on public transportation, a taxi or ride-sharing services. Keep your mask on during the commute and if possible, open any windows.

Q. Any final words of wisdom?

A. Due to the COVID-19 outbreak, many may not get to see their loved ones in-person this holiday. However, the pandemic is offering us a chance to create new, meaningful traditions. Your actions this holiday can have ramifications, not only for your family and community, but for the global community as well.

Ali Gholamrezanezhad, MD, a clinical emergency radiologist with Keck Medicine of USC, was one of the first researchers to study COVID-19 in early 2020. Today, Gholamrezanezhad has co-authored more than 40 papers on the disease, gathering and analyzing a wide array of data and patient scans. He offers his unique insights into a virus that has infected more than 43 million people worldwide.

Patients with COVID-19 don’t necessarily have expected symptoms

“When we run chest CT scans or X-rays on patients with COVID-19, we typically see scattered patchy areas of inflammation in the lungs, which we call atypical pneumonia. These patients usually suffer from a cough, difficulty breathing or chest pain, fatigue and fever.

“What we have found very surprising is that some patients with COVID-19 have no such symptoms. Instead, they present with abdominal pain, or even other symptoms, such as a stroke or an eye inflammation. Yet when we image their lungs, we find COVID-19. On the flip side, much less frequently, patients come in with a cough and fever, and chest imaging reveals that the lungs are clear or have minimal signs of inflammation.

“This may have to do with the fact that COVID-19 affects almost every organ in the body, not just the lungs as was originally thought when the pandemic first began.”

The lung damage caused may be long-term

“My colleagues and I conducted a systematic review of the available published literature on COVID-19 and discovered that up to 30% of patients hospitalized for the coronavirus have lung scarring months after their diagnosis. For patients with mild cases of COVID-19, including those who do not need to be hospitalized, the risk of scarring is generally low. However, for serious cases or people with pre-existing conditions, the risk is high.

“When a lung becomes scarred, the tissue thickens, and the lung works less efficiently. Scarring over 5% of the lung or less isn’t noticeable to most people, because we all have a lot of residual capacity in our lungs. However, if the scarring covers a larger area, patients may have difficulty breathing when they exercise or when they come down with a respiratory infection in the future.

“We don’t yet know if lung scarring due to COVID-19 will disappear over time. However, a study of severe acute respiratory syndrome (SARS), which is caused by another type of coronavirus, revealed that patients with SARS still had lung scarring 15 years after contracting the illness.”

Pregnant women may experience a unique complication from COVID-19

“In a systematic review of some 450 CT scans of pregnant women who had contracted COVID-19, we found that 30% had fluid in the pleural cavity that surrounds the lungs, making it harder to breathe. Of the general population with COVID-19, only about 5% show this symptom. This condition probably has to do with the body’s propensity to retain fluid during pregnancy, and is something obstetricians need to be aware of because it can lead to complications during delivery.”

Social distancing is key to prevention

“In another study, my colleagues and I wanted to see the effect that radiology equipment and health care resources played in COVID-19 fatality rates around the world. We investigated more than 20 variables in 40 countries, comparing not only health care-related factors, but issues such as a country’s wealth and education levels and prevalence of obesity, air travel, tobacco use and air pollution.

“We discovered that the biggest factor affecting death rates by far was social distancing. The later a country started the practice of social distancing, the higher the death rate during the first wave of the pandemic. In fact, our model revealed that even a 14-day delay in the implementation of social distancing significantly increased a country’s death rate.”

Don’t assume what we know today will hold true tomorrow

“Every day we are learning something new about COVID-19. What we know about this disease and how we treat it now may be dramatically different in six months to a year. As with all diseases, but never truer than with COVID-19, the learning phase in medicine never ends.”

How many potential COVID-19 vaccines are there?

Currently there are some 45 vaccine candidates testing in human clinical trials in addition to many being tested in animals. Researchers are using a wide variety of approaches to potentially stimulate an immune response in the body to protect against SARS-CoV-2, the virus that causes COVID-19. The most common type of vaccine candidate contains a virus that has been genetically engineered with coronavirus genes to provoke the intended immune response.

Can you explain the different phases of COVID-19 vaccine clinical trials?

After initial laboratory and animal testing is completed, vaccine candidates enter a phase 1 human clinical trial, where a small group of people (10-50) receive the trial vaccine to determine the dosing of a potential vaccine, potential side effects of the administration of the vaccine and safety of the vaccine. Phase 2 expands to hundreds of volunteers where we continue to test a vaccine for safety and collect early data about the vaccine’s potential efficacy.

In phase 3, the trial expands to tens of thousands of people to measure if the vaccine offers protection against SARS-CoV-2 infection or severe disease, and to continue to focus on safety in a diverse population. In the United States, the Food and Drug Administration (FDA) will approve a COVID-19 vaccine only after a successful phase 3 trial. Several potential COVID-19 vaccines are currently in phase 3 clinical trials, each including 30,000 or more volunteers.

How do Phase 3 clinical trials for potential COVID-19 vaccines work?

In these trials, one group of volunteers is randomly selected to receive the experimental vaccine, while another receives the placebo. Researchers then compare how many of those who were vaccinated become infected or ill with the coronavirus versus those who received a placebo. The FDA has determined that a COVID-19 vaccine must be at least 50% effective in preventing COVID-19 or, should someone contract the disease, in protecting against a serious case of COVID-19.

The trials are targeting high-risk-groups more likely to contract the virus or have severe complications to drive outcomes and get quicker results.

When will a vaccine be available and how effective will it be?

Some phase 3 COVID-19 vaccine clinical trials are getting close to completing the enrollment of volunteers. We could see one or more vaccines become available three to six months after the completion of a trial’s enrollment, which could be as soon as early next year.

It’s likely that people may need to be vaccinated each year, just as for the flu, but we don’t know for sure yet.

Vaccines typically take five to seven years to be developed. How is one for COVID-19 being developed so quickly and how can we know it’s safe?

We are benefitting from previous work done over the last decades to find safe, effective vaccines faster. In addition, the manufacturing of a vaccine traditionally begins after the vaccine has been approved through a phase 3 clinical trial. However, given the global emergency related to COVID-19, several state and private entities in the world have agreed to cover the costs of manufacturing millions of doses of potential COVID-19 vaccines during the clinical trials, shaving years off the process.

Despite the speed of development, scientists are adhering to the same rigid safety protocols for a COVID-19 vaccine that have been followed for all other previously approved vaccines and have proven to be safe, in some cases after several decades of use.

If someone is interested in volunteering for a trial, can they still participate?

Some half a million Americans have signed up to be part of a COVID-19 clinical trial, but more volunteers are needed to complete the trials, including people from high-risk populations and underserved communities. Anyone wishing to volunteer can register at https://coronaviruspreventionnetwork.org/.

Editor’s Note: Keck Medicine of USC is involved in an international phase 3 clinical trial for a COVID-19 vaccine sponsored by AstraZeneca and the University of Oxford.

The phase 3 clinical trial, which is also funded by the US Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases, aims to register 30,000 adult volunteers nationally: Keck Medicine plans on enrolling 500 of them.

“Participating in this trial is a historic moment that has great significance not only in the United States but for the entire world,” says the co-investigator of the study Edward Jones-Lopez, MD, MS, an infectious disease specialist at Keck Medicine. “It is an honor to have been selected as one of the trial sites, and we look forward to being part of the solution in the search for a vaccine for COVID-19.”
 

Prioritizing access for at-risk populations

Keck Medicine is enrolling participants at the greatest risk of contracting the coronavirus, such as those from the Latino and Black communities, those older than 65 and factory workers.

“We want to help those who could benefit the most,” says co-investigator Michael Dube, MD, an infectious disease specialist at Keck Medicine and interim chief of thedivision of infectious diseases at the Keck School of Medicine of USC.

The clinical trial will operate out of two locations: Keck Hospital of USC and a satellite location in Vernon, California, five miles south of downtown Los Angeles. The researchers, with the support of local health officials, selected Vernon because the city has a high concentration of factories and warehouses, including meat-packing plants. Many meat-packing houses have experienced high infection rates throughout the country during the pandemic.
 

Study protocol and background

The trial is a randomized, blind, placebo-controlled study. Two-thirds of the subjects will receive the vaccine in the form of two shots one month apart. The other third will receive a placebo injection.

Those receiving the vaccine will be asked to keep a symptom diary and receive periodic follow-up in-person and over the phone. Any subject who develops symptoms of COVID-19 will be seen and evaluated as needed. Researchers will measure the rate of symptomatic infection between the group receiving the vaccine and the placebo.

“At the end of the study, if the vaccine proves effective, those who received the placebo will have the option to be vaccinated,” Dube says.

The vaccine was developed by the University of Oxford in partnership with AstraZeneca, a global biopharmaceutical company. An earlier Phase 1/2 trial of more than 1,000 participants found that the vaccine induced a strong immune response to COVID-19, producing antibodies to fight infection, with most participants experiencing only mild side effects, such as fatigue and headaches. Early animal-model research yielded a similar immune response.

The vaccine is made from a weakened version of the common cold virus called an adenovirus that has been genetically modified to contain the coronavirus spike protein, a protein that binds to and infects the cells, explains Jones-Lopez. Once the protein is introduced into the body, the vaccine theoretically works by priming the immune system to attack the COVID-19 virus if it later infects the body.
 

Participating in the clinical trial

To volunteer for the study, individuals must be 18 or older who are at high risk of COVID-19 infection and able to comply with study procedures. Participants may have preexisting health conditions, however, must be in stable condition with no hospitalization or worsening of the disease three months before enrollment. People over the age of 65 years are encouraged to participate in this study.

To volunteer for this trial or other federally supported coronavirus vaccine trials either currently underway or planned for the future, please visit the COVID-19 Prevention Network.

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For more information about Keck Medicine of USC, please visit news.KeckMedicine.org.

DAS181 has demonstrated to be effective in fighting respiratory viruses, and limited preliminary data has suggested the drug may be beneficial for COVID-19 patients.

“The medication is thought to stop SARS-CoV-2, the virus that causes COVID-19, from penetrating and attaching to the cells lining the respiratory tract, therefore reducing the impact of the virus,” says Richard Castriotta, MD, a pulmonary critical care physician with Keck Medicine. “This drug may also improve patients’ immune response to the virus. Both actions should help reduce the severity and duration of COVID-19.”

Castriotta, who is also a professor of clinical medicine at Keck School of Medicine of USC,  is leading the trial for Keck Medicine with fellow researchers Janice Liebler, MD, and Aniket Sharma, MD.

This Phase 3 clinical trial is a double-blind, randomized controlled study. Half the participants will receive DAS181 through a nebulizer that delivers a vaporized form of the medication to the lungs and half will receive a placebo. The nebulizer is fitted with a mesh device that minimizes the risk of virus spread to health care workers.

Patients will receive the treatment twice a day from between 10 to 14 days, depending on their response. “The sooner someone recovers, the sooner they can stop the course of treatment,” says Castriotta. Participants will be tracked for approximately one month after treatment.

The study is open to individuals 18 years or older with a confirmed case of COVID-19 who have pneumonia and require supplemental oxygen. Those on ventilators are excluded from the study. However, participants who require a ventilator during the course of the treatment may remain in the trial.

Participants will be enrolled at Keck Hospital of USC, which is one of more than 30 sites across the United States and in Australia, South Korea and Taiwan participating in the trial.

DAS181 is manufactured by Ansun Biopharma, Inc., which is sponsoring the study.

Learn more about the clinical trial here.

Bottom line: Face coverings are critical for stopping the dramatic surge of COVID-19 cases statewide

“In just the last few days, California has seen a steep rise in the number of positive COVID-19 cases, particularly among people ages 18-40. In response, local health officials have scaled back reopenings to enforce social distancing. However, any time people are in public spaces, their faces must be covered. Masking is a sign of mutual respect and those choosing not to wear a mask are putting people around them at risk, which ultimately contributes to the growing numbers of new cases.

“Universal masking needs to be the new norm. It will require a proactive effort on everyone’s part to modify our practices and make face masks a part of the culture so we can outsmart this virus.”

Neha Nanda, MD, is an infectious disease specialist who serves as the healthcare epidemiologist and medical director of infection prevention and antimicrobial stewardship for Keck Medicine of USC.

A clean face covering is one line of defense against COVID-19

“The infectious particles that transmit SARS-CoV-2, the novel coronavirus that causes COVID-19 disease, are not laser-guided missiles. By creating obstacles that prevent transmission, we can limit the spread of the disease.

“The three easiest, cheapest and most effective obstacles to interrupt transmission are:

• Increase ventilation — air currents blow away and evaporate the particles containing the virus.
• Maintain safe distances from others — particles are not likely to travel beyond six feet.
• Wear a face covering — this is an easy and effective way to prevent particles from leaving and entering the nose and mouth.

“In line with recommendations from the Centers for Disease Control and Prevention, reusable face masks should be washed after each use or added to the laundry to prevent the virus from staying on tabletops and other surfaces. We recommend that families use different patterns to prevent sharing used masks."

Edward Jones-Lopez, MD, MS, is an infectious disease specialist with Keck Medicine of USC.

Cover your face while exercising — but be vigilant about your heart health

“Face coverings can dramatically reduce the risk of transmission in public spaces, so it is essential to wear them even while doing physical activity, particularly if you are exercising indoors with others around you. Face coverings should allow you to stay safe and still maintain a healthy flow of oxygen, so if you feel lightheaded or too short of breath, you should decrease your exercise intensity."

Vivian Mo, MD, is a cardiologist with Keck Medicine of USC and chief medical officer of USC Care Medical Group.

Keep your face and mask clean to avoid mask-related acne, or “maskne”

“Wearing a face covering for extended periods of time can trap bacteria, dirt, oil and moisture in the skin, causing “maskne,” skin irritation and exacerbation of underlying skin conditions. It is important to wear breathable fabrics such as cotton and to wash your face before and after wearing the mask with a gentle cleanser followed by a moisturizing cream, which can help calm irritation and restore the skin's natural barrier. We recommend avoiding makeup, toners and harsh scrubs. If your skin's condition is worsening or not improving, set up an appointment with a board-certified dermatologist for further evaluation and treatment.”

Nada Elbuluk, MD is a dermatologist with Keck Medicine of USC and the director of the USC Skin of Color and Pigmentary Disorders Program.

A polarized political environment is preventing widespread adoption of face coverings

"In general, Americans are mindful of public health recommendations, but today we find ourselves in an unfortunate situation. Political polarization is colliding with a crisis of expertise and a long strain of suspicion of government intervention. It’s all contributing to the difficulty of getting some people to engage in a simple public health measure of mask-wearing in public."

Andrew Lakoff, PhD is a professor of sociology at USC Dornsife College of Letters, Arts and Sciences. He was trained as an anthropologist of science and medicine. His areas of interest include globalization processes, the history of the human sciences, contemporary social theory, and risk society. 

To keep your cool in the mask debate, focus on what you can control

“Masks are the new badge of honor. Wearing your mask in public is a statement that can help put people around you at ease. It says that you care about the health and welfare of your neighbors. Not wearing a mask in public says just the opposite and may cause others around you to feel anxious.

“If you are anxious about being outside around other people who do not wear masks, you can cross the street or move to the side. In short, focus your effort where it belongs. We have power over our own choices and behavior, but we cannot control the rest of the world.”

Steven Siegel, MD, PhD, is a psychiatrist with Keck Medicine of USC and chair of the Department of Psychiatry and Behavioral Sciences at the Keck School of Medicine of USC. He recently helped create the Care for the Caregiver program, which offers mental health support along with other essential services for Keck Medicine health care workers during the COVID-19 pandemic.

“During this time when the American public is already mentally stretched thin due to the stresses of COVID-19, the expression of national outrage is a normal and understandable response. During turmoil, as always, it is key that we acknowledge and address all forms of trauma, including the psychological trauma caused by racism. The recent events leading up to protests nationwide have made the call for mental health support all the more urgent across all communities.”

Steven Siegel, MD, PhD, is a psychiatrist with Keck Medicine of USC and chair of the Department of Psychiatry and Behavioral Sciences at the Keck School of Medicine of USC. He recently launched the Care for the Caregiver program, which offers mental health support for Keck Medicine health care workers during the COVID-19 pandemic.

 

Safety tips for protesting in a pandemic

“Protests, which often put people in close contact with others for extended periods of time, pose the risk of increasing transmission of COVID-19 if physical distancing and hand hygiene are forgone. While being outside may dilute the virus, especially if the wind is blowing, it’s still important to take basic precautions to reduce the risk of COVID-19:

• Avoid close contact whenever possible and maintain a distance of at least six feet between you and others.
• Sanitize your hands, either with soap and water or hand sanitizer, regularly and immediately after touching someone or something, or coughing or sneezing. Carry hand sanitizer with you at all times.
• Wear a mask or face covering while outside and around people at all times.
• Minimize bringing unnecessary items with you, as you will have less items to disinfect later
• Wash all clothes and items you wore or brought immediately after returning home.

“After attending a protest, it is also important to closely monitor your health. Keep a close eye out for symptoms such as a cough, fever or chills, shortness of breath, muscle aches, headaches, new loss of taste or smell, sore throat, nausea, vomiting or diarrhea. Call your doctor if these symptoms develop. If you’re sick or have serious preexisting medical conditions, consider alternative ways to support protestors.”

Neha Nanda, MD, is the medical director of infection prevention and antimicrobial stewardship for Keck Medicine of USC.

How tear gas affects the respiratory system and eyes

“Tear gas causes excessive irritation to the eyes, nose, mouth and upper respiratory system, causing choking, gasping and respiratory secretions. The effects generally last a few minutes, and most will quickly recover. However, for those with underlying lung conditions, the particles can affect the lower airways in the lung and cause bronchospasm and even respiratory failure. This group should seek medical help at a hospital if exposed.

“Coughing is a normal reaction to tear gas, which clears out the lungs, but people should make sure they separate from others when coughing or around those coughing to avoid the spread of COVID-19.”

Richard J. Castriotta, MD, is a pulmonary critical care physician with Keck Medicine of USC. He is an internationally recognized leader in pulmonary, critical care and sleep medicine as a clinician, teacher and researcher.

“Tear gas burns the front of the eyes (the cornea), which is the window that allows us to see. If the cornea is burned and scarred, it can lead to blindness. The best thing to do if tear gassed is to flush the eye with water for at least 30 minutes. It’s important to make sure the eye is open when doing so, and that water is getting into the eye, as well as under the eyelid. People should flush the eye immediately and without delay on-site using bottled water, if at all possible.”

Kimberly Gokoffski, MD, PhD, is an ophthalmologist with the USC Roski Eye Institute, Keck Medicine of USC. She has a clinical specialty in neuro-ophthalmology.

Come prepared and seek medical help if needed

“Those who peacefullly protest should bring a first-aid kit that contains the basics like band-aids and antibiotic ointment, as well as drink plenty of water to guard against dehydration.

“If anyone becomes injured and needs immediate medical help, visit your local emergency department. Emergency departments are open and safe for all urgent and emergency needs. Hospitals are putting numerous safety practices in place to ensure patients are safeguarded from the possible spread of the coronavirus, so people should feel comfortable going there if needed.”

Armand Dorian, MD, MMM, is the chief medical officer of USC Verdugo Hills Hospital, overseeing all medical operations at the hospital, including the hospital’s Emergency Department.

“We are learning that in some COVID-19 cases, inflammation might be driving the need for intubation and causing poor outcomes,” says Michael Dube, MD, an infectious disease specialist at Keck Medicine and interim chief of the division of infectious diseases at the Keck School of Medicine of USC.

Dube is heading up the trial with Heinz-Josef Lenz, MD, associate director of clinical research of the USC Norris Comprehensive Cancer Center, who serves as the principal investigator.

For certain patients, COVID-19 may trigger a “cytokine storm,” explains Dube. Cytokines are small proteins in the body that help the immune system battle infection. However, having a large amount released into the body all at once can result in excess inflammation that causes tissue damage and organ failure.

Baricitinib has been shown to lower levels of a cytokine known as interleukin-6, as well as other cytokines.

“Our premise is that by using baricitinib to reduce the inflammation, we may be able to slow down the progress of the disease, stop the need for a ventilator and save lives,” says Dube.

The drug is one of several anti-inflammatories being tested for use in patients with COVID-19.

Dube and Lenz will collaborate with Bodour Salhia, PhD, an assistant professor of translational genomics at the Keck School, on related but different research. Salhia will collect blood samples drawn during the trial to look for molecular biomarkers to identify COVID-19 patients who are at high-risk for developing severe outcomes. Salhia will use a liquid biopsy methodology she has already developed for cancer research.

“Finding such biomarkers will lead to better management and protection of high-risk individuals,” she says.

The clinical trial is a double-blind, randomized controlled study. Half the participants will receive baricitinib in the form of a daily tablet medication and the other half will receive a placebo. Researchers plan to enroll 144 patients from Keck Hospital of USC, USC Verdugo Hills Hospital and Los Angeles County + USC Medical Center.

Participants will include patients who exhibit COVID-19 symptoms but have not reached the stage where they have to be intubated. Patients with a heightened risk factor for the virus, such as those 60 or older, with a chronic heart or lung condition, obesity, hypertension or diabetes, are also eligible.

The pharmaceutical company Eli Lilly and Company provided funding for this study.

Photo credit: Ricardo Carrasco III

The program is available to staff who have had direct exposure to COVID-19 and wish to self-quarantine away from home or safeguard family members. Additionally, housing is available for workers needing a respite. Housing may include accommodations on the Health Sciences Campus, the USC Hotel or in corporate housing downtown.  

“Our health care workers are on the frontline of the COVID-19 pandemic, and their personal safety, and that of their loved ones, is our number one priority,” says Tammy Capretta, RN, MPH, chief transformation and risk officer for Keck Medicine. “We have been humbled by their commitment and dedication to our patients, and we want to do everything we can to help ease any burdens they are facing.”  

Staff will also have access to sessions over the phone or through virtual visits as well as access to a video support group with a live therapist to promote well-being and emotional support. Sixty therapists are available for consultations, with 120 more available as needed.  

“Our health care providers are working under taxing conditions and dealing with anxiety, sadness and other painful emotions as they face an unprecedented health crisis,” says Steven Siegel, MD, PhD, Keck Medicine psychiatrist and chair of the Department of Psychiatry and Behavioral Sciences at the Keck School of Medicine of USC. “It’s crucial for their well-being that they have access to free professional mental health care during this time.”  

Those in the program will also have access to meals, groceries, toiletries and other essential and comfort items to help them recover and unwind.  

The Care for the Caregiver program will continue to roll out more amenities for staff in the upcoming weeks. 

Keck Medicine will also be inviting the community to donate self-care items to the health care workers. Those interested in donating can check the Keck Medicine website for information as it becomes available.  

New Procedures: 

• Many elective inpatient and outpatient surgeries will be rescheduled on a case-by-case basis. 

• Keck Medicine has established an isolated screening facility for health care workers and patients exhibiting viral symptoms at its Keck Hospital of USC location.  

• An increased number of patients are using telemedicine for appointments. 

New Preventive Measures:  

• Keck Hospital and USC Norris Cancer Hospital have initiated a no-visitor policy for admitted patients, with exceptions for patients who are at end of life or other critical situations. 

• Keck Medical Center of USC buildings have limited entry points and fever screenings are taking place at all clinical entry points. Visitors to outpatient locations will be screened for fever upon check-in.  

• Anyone with respiratory symptoms or fever will be given a mask and redirected based on assessment of their clinical condition.  

• Medical students at the Keck School of Medicine of USC have been pulled from clinical rounds and from working directly with patients at Keck Medicine clinical locations. 

“As COVID-19 spreads, we will continue to take all necessary precautions to protect our patients, staff and community and to effectively manage this virus,” says Rodney Hanners, COO of Keck Medicine and CEO of Keck Medical Center. “All of our efforts right now are directed at developing procedures and protocols to provide our patients and community with compassionate care while ensuring their safety.” 

Learn more about Keck Medicine COVID-19 efforts by visiting its COVID-19 website. For more information about how USC is handling the outbreak, please visit usc.edu. 

Visitors & Patients 

• All patients are being screened for COVID-19 and triaged for appropriate treatment, including remote treatment at home by a recently activated clinical team. 

• When visiting hospitalized patients, only one visitor over the age of 14 will be permitted at a time; compassionate exceptions for critical situations will be granted. 

• Non-essential visitors (such as vendors or community members) will not be granted access to any facility.  

Staff 

• All health care providers with Keck Medicine have been credentialed to practice telemedicine in order to expand capacity, enabling virtual visits with patients instead of in-person. 

• Domestic and international travel has been restricted for staff. Those who have returned from international travel are being screened for COVID-19 and managed accordingly. 

• An automated re-order system for supplies has been in effect to ensure facilities remained stocked. The health system is confident in its ability to provide sufficient supplies for our staff and patients and will continuously monitor the situation. 

• Surge planning is underway, including temporary structures for additional clinical screening and isolation.  

“We are being incredibly proactive and are enacting all necessary precautions at our facilities, both acute and outpatient, to protect our community and slow the spread of COVID-19,” says Rodney Hanners, COO of Keck Medicine of USC and CEO of Keck Medical Center of USC.  “The well-being of our staff, patients and loved ones is foremost in our planning as we continue to provide a safe environment without compromising our exceptional patient care.”  

“All of our procedures are developed for the maximum safety and care of our patients,” says Stephanie Hall, MD, chief medical officer of Keck Medicine. “The ability of our providers to provide virtual visits is an especially important development as we fight this outbreak, and just one of many ways we are protecting both our staff and patients.” 

The World Health Organization has labeled COVID-19 a pandemic. In an ongoing effort to keep the public informed about the disease, Keck Medicine has created a COVID-19 website that will be updated regularly.