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University of Utah COVID-19 Hydrochloroquine Trial

NCT04342169 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2023-02-15

Study results available
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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.

Conditions

Interventions

DRUG

Hydroxychloroquine

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

DRUG

Placebo oral tablet

Placebo to be taken on the same schedule as HCQ.

Sponsors & Collaborators

Principal Investigators

  • Adam Spivak, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-04
Primary Completion
2021-10-30
Completion
2021-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

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 NCT04342169 on ClinicalTrials.gov