CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 368 enrolled
Drug / intervention
Hydroxychloroquine +1 moredrug
Likely dose
Hydroxychloroquine 400mgfrom 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/NCT04342169
NCT04342169Phase 2Completed

Hydroxychloroquine for Outpatients With Confirmed COVID-19

University of Utah·interventional·Posted Apr 10, 2020·Updated Feb 15, 2023

In Brief

A Phase 2 clinical trial evaluating Hydroxychloroquine and Placebo oral tablet for Coronavirus Infection and 2 related conditions. Completed, enrolled 368 participants across 1 site.

Detailed Summary

A novel coronavirus, SARS-CoV-2, is responsible for a rapidly spreading pandemic that has reached 160 countries, infecting over 500,000 individuals and killing more than 24,000 people. SARS-CoV-2 causes an acute and potentially lethal respiratory illness, known as COVID-19, that is threatening to overwhelm health care systems due to a dramatic surge in hospitalized and critically ill patients. Patients hospitalized with COVID-19 typically have been symptomatic for 5-7 days prior to admission, indicating that there is a window during which an effective intervention could significantly alter the course of illness, lessen disease spread, and alleviate the stress on hospital resources. There is no known treatment for COVID-19, though in vitro and one poorly controlled study have identified a potential antiviral activity for HCQ. The rationale for this clinical trial is to measure the efficacy and safety of hydroxychloroquine for reducing viral load and shedding in adult outpatients with confirmed COVID-19.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedApr 10, 2020
Enrollment StartApr 4, 2020
Primary CompletionOct 30, 2021
Study CompletionNov 15, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 6.2 years ago

Interventions

Hydroxychloroquinedrug

HCQ 400mg po BID x 1 day, then 200mg po BID x 4 days

Placebo oral tabletdrug

Placebo to be taken on the same schedule as HCQ.