EXCLUSIVE: Questions for Ann Collier, MD on her latest study on a COVID-19 treatment
May 28, 2020 | MK Scott
As we announced last week, Dr. Ann Collier, well known AIDS researcher and Director of the UW AIDS Clinical Trials Unit is heading up a new study for a potential COVID-19 treatment. I had a chance to chat with Dr. Collier via email earlier this week.
MK Scott: Please refresh our readers on your background?
Dr. Ann Collier: I am a doctor, Professor of Medicine and Infectious Diseases at the University of Washington, and Director of the UW AIDS Clinical Trials Unit. I have been involved with the care of people living with HIV and clinical research to improve treatment of HIV for over 30 years.
MK: You just launched a new study for a COVID-19 treatment. Can you briefly explain this study?
DC: This national study compares a combination of 2 medicines to 2 inactive "look-alike" (placebo) pills. The visits for this study are done by telephone. Participants are adults (with or without HIV) with mild COVID-19 symptoms who were diagnosed by nasal swab collected within the past 96 hours. The medicine is taken for 7 days; it is a combination of low dose hydroxychloroquine and azithromycin. There has been a lot of social media controversy about this combination based upon "observational" studies of hospitalized persons. There is still no FDA-approved treatment for COVID-19 and we need rigorous clinical trials to help us identify safe and effective treatments. It is also important to know that this study was designed with a lot of safeguards, including dose of the medication and excluding people at risk for side effects. Participants are asked to keep a simple diary about their symptoms for 20 days. Reimbursement is $50 at day 20.
MK: You are known as an AIDS researcher. Can you explain the difference between the HIV virus vs the coronavirus?
DC: HIV and coronaviruses are members of different virus "families". Both are RNA viruses. HIV is a retrovirus. The virus that causes COVID-19 is called SARS-CoV-2. It is a member of the coronavirus family. Other differences include the types of cells that these viruses infect (enter) and the way these viruses enter human cells.
MK: What are your hopes for the study?
DC: My main hope is that this study will generate valuable and valid information about whether this combination of medicines and low dose of hydroxychloroquine is safe and effective for treatment of mild COVID-19.
MK: What have been the challenges so far?
DC: One major challenge is that the visits are being done by phone. This creates lots of new issues, including about how to provide informed consent via phone, how to confirm who the participant is, how to deliver the study medicine, how to collect the study diary, and provide the study reimbursement. The news about results of observational studies in hospitalized patients have led many people to think this combination has toxicity and decreased interest in studies of hydroxychloroquine. In addition, there is a short window of opportunity for people to join the study. They must enroll within 96 hours of the swab collection that shows they have COVID-19. I am proud that our team was able to screen, enroll, and deliver the first participant's study medication to them all in one day.
MK: I have heard rumors that PReP (Truvada) has helped in decreasing the risk to COVID-19. Do you think that is possible?
DC: There are multiple medications that have been shown in the test tube to suppress SARS-CO-V2, and Truvada, the first medicine to be used as PrEP, is not one. The one anti-HIV medicine (antiretroviral) that is being studied for treatment of COVID-19 is the protease inhibitor lopinavir boosted by ritonavir. It has the trade name Kaletra®, and consists of two medicines in one pill.
MK: How long do you think the social distancing will last?
DC: There is a lot of variability across the state and the U.S. Sorry, I don't have a crystal ball.
MK: Nursing homes are experiencing the most cases. How can they maintain safety?
DC: Important actions include the testing of staff, frequent handwashing with soap for at least 20 seconds, keeping residents apart by closing common areas, excluding visitors with symptoms of COVID-19, and the wearing of masks by occupants, staff, and visitors.
Many nursing homes have banned visitors and encourage communication via Facebook, Zoom, Facetime, or other electronic tools.
If you test positive for COVID-19 and would like to participate in this study, please call or text 206-773-7129 or email firstname.lastname@example.org.
NOTE: PLEASE CONTINUE TO BE SAFE. Wear a face mask when out in public. Maintain 6 feet social distance when possible. Wash hands with soap and hot water for 20 seconds. https://www.cdc.gov/handwashing/index.html.
If you're feeling sick, stay home. If you have symptoms of COVID-19, a cough, fever, or trouble breathing, contact your health care provider before going to a medical facility. If you have an emergency, call 911.
Washington State COVID-19 Hotline: 800-525-0127; Washington State Crisis Connection: 866-4-CRISIS (866-427-4747).