This individually randomized telemedicine-based trial aims to evaluate the efficacy of a single dose of azithromycin for prevention of progression of COVID-19 in patients with a recent positive SARS-CoV-2 test who are not currently hospitalized.
Identification of a safe, effective treatment for individuals with mild or moderate COVID-19 that prevents disease progression and reduces hospitalization would reduce the burden on the health system. High dose hydroxychloroquine is being evaluated for SARS-CoV-2 prevention and COVID-19 disease treatment, but has a high risk of a number of potentially severe adverse events. Recent evidence has indicated that the broad-spectrum macrolide azithromycin may have some activity against coronaviruses. Here we propose an individually-randomized, placebo-controlled trial to determine the efficacy of a single dose of azithromycin for prevention of COVID-19. Potential participants will undergo remote eligibility screening with study staff prior to enrollment. Upon determination of eligibility and signing electronic informed consent documents, participants will be emailed baseline study forms and will be mailed their randomized study treatment. At the end of the study (21 days), participants will be emailed a final study questionnaire. Note that there will no contact between study staff and participants in this trial, minimizing risk of infection spread.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
263
Participants will be shipped a single 1.2 g dose of oral azithromycin
Participants will be shipped a dose of matching placebo
University of California San Francisco
San Francisco, California, United States
Number of Participants Who Were Symptom Free at Day 14
Binary assessment of whether the participant is experiencing any symptoms at Day 14 (yes or no)
Time frame: 14 days
Viral Load - Nasal Swab
Viral load by self-collected nasal swab
Time frame: 3 days
Viral Load - Saliva Swab
Viral load by self-collected saliva swab
Time frame: 3 days
Mortality
All-cause mortality
Time frame: 14 days
Adverse Events
Percentage of participants experiencing adverse events, including gastrointestinal side effects and rash
Time frame: 3 days
Positive SARS-CoV-2 Test - Nasal Swab
Prevalence of positive SARS-CoV-2 test by self-collected nasal swab
Time frame: 3 days
Positive SARS-CoV-2 Test - Saliva Swab
Prevalence of positive SARS-CoV-2 test by self-collected saliva swab
Time frame: 3 days
Positive SARS-CoV-2 Test - Rectal Swab
Prevalence of positive SARS-CoV-2 test by self-collected rectal swab
Time frame: 3 days
Genetic Macrolide Resistance Determinants
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Prevalence of genetic macrolide resistance determinants by self-collected rectal swab
Time frame: 3 days
Secondary Outcomes Through Day 21
Prevalence of cough, fever, myalgia, anosmia, shortness of breath, fatigue, conjunctivitis, and orthostatic symptoms through Day 21
Time frame: Cumulative over 21 days reported (assessed at 3, 7, 14, 21 days)
Number of Participants With Emergency Room Visits
Number of emergency room visits \<24 hours
Time frame: 21 days
Number of Household Members With COVID-19 (Confirmed or Symptomatic)
Number of household members with confirmed or symptomatic COVID-19 through Day 21
Time frame: 21 days
Number of Participants That Died
Deaths within the study
Time frame: 21 days
Number of Participants Reporting Hospitalization
Number of hospitalizations defined as a hospital stay or ER stay longer than 24 hours through 21 days post enrollment
Time frame: 21 Days