Clinical trial NCT04332107: Azithromycin for COVID-19 Treatment in Outpatients Nationwide
Official title: Azithromycin for Prevention of Disease Progression in Patients With Mild or Moderate COVID-19
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: COVID-19
SARS-CoV-2
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Pfizer
name: Stanford University
First posted: 2020-04-02
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Evidence of a positive SARS-CoV-2 test and test results received within the previous seven days
* Not currently hospitalized
* Willing and able to receive study drug by mail
* Willing and able to do the study questionnaires at baseline, day 3, 7, 14, 21 days via email or over the phone
* No known allergy or other contraindication to macrolides
* Age 18 years or older at the time of enrollment
* No known history of prolongation of the QT interval (eg. History of torsades de pointes, congenital long QT syndrome, bradyarrhthmia)
* No recent use of hydroxychloroquine within the past 7 days for participants \>55 years of age
* Not currently taking nelfinavir or warfarin (Coumadin)
* Provision of informed consent
* Not currently pregnant

Primary outcomes:
measure: Number of Participants Who Were Symptom Free at Day 14
timeFrame: 14 days
Secondary outcomes:
measure: Viral Load - Nasal Swab
timeFrame: 3 days
measure: Viral Load - Saliva Swab
timeFrame: 3 days
measure: Mortality
timeFrame: 14 days
measure: Adverse Events
timeFrame: 3 days
measure: Positive SARS-CoV-2 Test - Nasal Swab
timeFrame: 3 days
measure: Positive SARS-CoV-2 Test - Saliva Swab
timeFrame: 3 days
measure: Positive SARS-CoV-2 Test - Rectal Swab
timeFrame: 3 days
measure: Genetic Macrolide Resistance Determinants
timeFrame: 3 days
measure: Secondary Outcomes Through Day 21
timeFrame: Cumulative over 21 days reported (assessed at 3, 7, 14, 21 days)
measure: Number of Participants With Emergency Room Visits
timeFrame: 21 days
measure: Number of Household Members With COVID-19 (Confirmed or Symptomatic)
timeFrame: 21 days
measure: Number of Participants That Died
timeFrame: 21 days
measure: Number of Participants Reporting Hospitalization
timeFrame: 21 Days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Catherine Oldenburg, ScD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Thuy Doan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oldenburg CE, Pinsky BA, Brogdon J, Chen C, Ruder K, Zhong L, Nyatigo F, Cook CA, Hinterwirth A, Lebas E, Redd T, Porco TC, Lietman TM, Arnold BF, Doan T. Effect of Oral Azithromycin vs Placebo on COVID-19 Symptoms in Outpatients With SARS-CoV-2 Infection: A Randomized Clinical Trial. JAMA. 2021 Aug 10;326(6):490-498. doi: 10.1001/jama.2021.11517.