Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Azithromycin
1.2g of oral azithromycin
  • Drug: Azithromycin
    Participants will be shipped a single 1.2 g dose of oral azithromycin
Placebo Comparator
Placebo
Matching placebo
  • Drug: Placebos
    Participants will be shipped a dose of matching placebo

Recruiting Locations

University of California San Francisco
San Francisco, California 94143
Contact:
Jessica M Brogdon, MPH
415-514-1582
ACTIONTrial@ucsf.edu

More Details

NCT ID
NCT04332107
Status
Recruiting
Sponsor
Thomas M. Lietman

Study Contact

Jessica M Brogdon, MPH
(415) 514-1582
ACTIONTrial@ucsf.edu

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 progression to hospitalization. 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.