Azithromycin for COVID-19 Treatment in Outpatients Nationwide

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NCT04332107

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Study Location
University of California San Francisco
San Francisco, California, 94143, United States
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Contact
(415) 514-1582
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
COVID-19, SARS-CoV-2
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

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COVID-19, SARS-CoV-2Azithromycin for COVID-19 Treatment in Outpatients Nationwide
NCT04332107
  1. San Francisco, California
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Azithromycin for COVID-19 Treatment in Outpatients Nationwide
Official Title  ICMJE Azithromycin for Prevention of Disease Progression in Patients With Mild or Moderate COVID-19
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • SARS-CoV-2
Intervention  ICMJE
  • Drug: Azithromycin
    Participants will be shipped a single 1.2 g dose of oral azithromycin
  • Drug: Placebos
    Participants will be shipped a dose of matching placebo
Study Arms  ICMJE
  • Experimental: Azithromycin
    1.2g of oral azithromycin
    Intervention: Drug: Azithromycin
  • Placebo Comparator: Placebo
    Matching placebo
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 1, 2020)		2271
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jessica M Brogdon, MPH(415) 514-1582[email protected]
Contact: Catherine Cook, MPH[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04332107
Other Study ID Numbers  ICMJE 20-30504
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Supporting Materials:Study Protocol
Supporting Materials:Statistical Analysis Plan (SAP)
Supporting Materials:Informed Consent Form (ICF)
Supporting Materials:Clinical Study Report (CSR)
Supporting Materials:Analytic Code
Responsible Party Thomas M. Lietman, University of California, San Francisco
Study Sponsor  ICMJE Thomas M. Lietman
Collaborators  ICMJE
  • Bill and Melinda Gates Foundation
  • Pfizer
  • Stanford University
Investigators  ICMJE
Principal Investigator:Catherine Oldenburg, ScD, MPHUniversity of California, San Francisco
Principal Investigator:Thuy Doan, MD, PhDUniversity of California, San Francisco
PRS Account University of California, San Francisco
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP