Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
Catherine Oldenburg (ucsf)Thuy Doan, MD, PhD (ucsf)
Photo of Thuy Doan
Thuy Doan

Description

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.

Official Title

Azithromycin for Prevention of Disease Progression in Patients With Mild or Moderate COVID-19

Details

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.

Keywords

COVID-19 SARS-CoV-2 Azithromycin

Eligibility

For people ages 18 years and up

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

Location

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientists at UC Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Thomas M. Lietman
ID
NCT04332107
Phase
Phase 3
Study Type
Interventional
Last Updated