MedTrace Logo

Azithromycin Plus Hydroxychloroquine for COVID-19 Infection

NCT05026801 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-10-28

No results posted yet for this study

Summary

This is a randomized, double-blinded, Phase 3, multi-center trial of the clinical and microbiologic response of patients with a respiratory tract infection (RTI) due to coronavirus treated with a combination of azithromycin and hydroxychloroquine.

Approximately 200 patients with symptoms of an RTI who test positive for SARS-CoV-2 by polymerase chain reaction (PCR) will receive a combination of azithromycin 500 mg and hydroxychloroquine 600 mg or matching placebos for six consecutive days. There will be two treatment regimens into which patients are randomized so that all patients will receive some active therapy.

Conditions

  • Respiratory Tract Infection Viral

Interventions

DRUG

Azithromycin plus hydroxychloroquine

All patients will receive active comparator. One group will receive placebo on D1-3 followed by active comparator D4-9, while the other group will receive active comparator D1-6 followed by placebo D7-9.

Sponsors & Collaborators

  • Waterbury Hospital

    collaborator UNKNOWN

  • Iterum Therapeutics, International Limited

    lead INDUSTRY

Principal Investigators

  • Michael Dunne, MD · Iterum Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-08
Primary Completion
2021-08-26
Completion
2021-08-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05026801 on ClinicalTrials.gov