NCT04332107

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
263

participants targeted

Target at P25-P50 for phase_3 covid19

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 22, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
5 months until next milestone

Results Posted

Study results publicly available

September 9, 2021

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

10 months

First QC Date

March 30, 2020

Results QC Date

August 9, 2021

Last Update Submit

February 1, 2023

Conditions

COVID-19SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

  • 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)

    14 days

Secondary Outcomes (13)

  • Viral Load - Nasal Swab

    3 days

  • Viral Load - Saliva Swab

    3 days

  • Mortality

    14 days

  • Adverse Events

    3 days

  • Positive SARS-CoV-2 Test - Nasal Swab

    3 days

  • +8 more secondary outcomes

Study Arms (2)

Azithromycin

EXPERIMENTAL

1.2g of oral azithromycin

Drug: Azithromycin

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebos

Interventions

AzithromycinDRUG

Participants will be shipped a single 1.2 g dose of oral azithromycin

Azithromycin
PlacebosDRUG

Participants will be shipped a dose of matching placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

  • 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.

    PMID: 34269813DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Limitations and Caveats

This trial was terminated early by the DSMC for futility on March 16, 2021. Therefore, we were not able to complete the analysis for all secondary outcomes because funds were returned to the sponsor following the completion of the study. Please note that the number of participants varies by period as participants could opt to complete some questionnaires but not others. For example, a participant may skip the day 3 questionnaire, but complete the day 14 questionnaire.

Results Point of Contact

Title
Dr. Thomas Lietman, Director of the UCSF FI Proctor Foundation
Organization
University of California, San Francisco FI Proctor Foundation
tom.lietman@ucsf.edu
415-476-1442

Study Officials

  • Catherine Oldenburg, ScD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Thuy Doan, MD, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 2, 2020

Study Start

May 22, 2020

Primary Completion

March 16, 2021

Study Completion

March 30, 2021

Last Updated

March 2, 2023

Results First Posted

September 9, 2021

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US(1)