Why are we conducting this study?
There is currently a lack of evidence about how to treat COVID-19. Our team at the Proctor Foundation at UCSF is conducting this study to evaluate whether azithromycin reduces the severity of illness for patients who have COVID-19 but are not in the hospital. We do not know if azithromycin will help to reduce the severity of illness although there is limited evidence to suggest that it may have activity against some viruses. We will compare the efficacy of azithromycin to a placebo pill, like a sugar pill, which has no effect against the virus. If azithromycin reduces the severity of illness, this treatment could be used in patients with COVID-19 globally.
The azithromycin dose used in this study is similar to what is used for treatment of many common bacterial infections. You will only take the study medication once. This dose is generally safe. The most common side effects are upset stomach or abdominal discomfort, and it is usually mild. Side effects stop when you are no longer taking the medication.
What is involved in participating in this study?
If you agree to participate in this study, we will ask you to:
- Agree to be randomly assigned to receive a single dose of azithromycin or a placebo pill (sugar pill). If you agree, you will have a 2:1 chance of receiving azithromycin or the placebo pill (67% chance of azithromycin, 33% chance of placebo).
- Answer 4 short online or telephone follow-up surveys.
- Optional: you can opt-in to self-collect samples after enrollment and ship them back to our laboratory. The study coordinator will ask you during the informed consent procedure if you would like to opt-in to the swab study. The swabs will help us understand if the study treatment has an effect on the virus itself. Participation in the swab study is NOT required to participate in the trial.
This study is not a substitute for your normal medical care. You will not need to complete any in-person visits for this study, and you may participate from anywhere in the United States.
Additional details of this study can be found at ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT04332107