Pragmatic Factorial Trial of Hydroxychloroquine, Azithromycin, or Both for Treatment of Severe SARS-CoV-2 Infection

SARS-CoV-2 Clinical Trial

Official title: Pragmatic Factorial Trial of Hydroxychloroquine, Azithromycin, or Both for Treatment of Severe SARS-CoV-2 Infection

Status Terminated

Clinical Trial Summary

This is a pragmatic, randomized, open-label, incomplete factorial with nested randomization clinical trial evaluating the efficacy and safety of two potential treatments for hospitalized patients with confirmed SARS-CoV-2 infection. Participants who are hospitalized and have a positive nucleic acid amplification test for SARS-CoV-2 will undergo an initial randomization in a 1:1 ratio to one of the following regimens:

Arm 1: Standard of care alone

Arm 2: Standard of care plus hydroxychloroquine

Participants who meet eligibility criteria to receive azithromycin will undergo a second randomization in a 1:1 ratio to receive additional concurrent therapy. This will effectively result in four treatment groups:

1. Standard of care alone

2. Standard of care plus hydroxychloroquine

3. Standard of care plus azithromycin

4. Standard of care plus hydroxychloroquine plus azithromycin

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Infection
• SARS-CoV-2

• NCT number: NCT04335552
• Study type: Interventional
• Source: Duke University
• Status: Terminated
• Phase: Phase 2
• Start date: April 17, 2020
• Completion date: June 26, 2020