CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,312 enrolled
Drug / intervention
Hydroxychloroquine +1 moredrug
Likely dose
Hydroxychloroquine 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04308668
NCT04308668Phase 3Completed

Post-exposure Prophylaxis or Preemptive Therapy for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial

University of Minnesota·interventional·Posted Mar 16, 2020·Updated May 13, 2021

In Brief

A Phase 3 clinical trial evaluating Hydroxychloroquine and Placebo for Corona Virus Infection and 4 related conditions. Completed, enrolled 1,312 participants across 5 sites in 2 countries.

Detailed Summary

Study Objective: 1. To test if post-exposure prophylaxis with hydroxychloroquine can prevent symptomatic COVID-19 disease after known exposure to the SARS-CoV-2 coronavirus. 2. To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity.

Study Details

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedMar 16, 2020
Enrollment StartMar 17, 2020
Primary CompletionMay 20, 2020
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 6.3 years ago

Interventions

Hydroxychloroquinedrug

200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days

Placeboother

4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days