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HEalth Care Worker pROphylaxis Against COVID-19: The HERO Trial

NCT04352946 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2020-04-22

No results posted yet for this study

Summary

This is a double-blinded, randomized placebo-controlled trial to determine if pre-exposure prophylaxis (PrEP) with 400mg hydroxychloroquine (HCQ), taken orally once daily, for health care workers in the hospital reduces symptomatic and asymptomatic COVID-19 disease during the pandemic. 374 health care workers will be randomized at a 1:1 allocation between the intervention and placebo arms and followed for 90 days. The cumulative incidence of COVID-19 infection in the intervention group will be compared to the cumulative incidence of COVID-19 in the placebo group with relative (risk ratio and 95% CI) and absolute measures (risk difference and 95% CI).

Conditions

  • Prophylaxis
  • COVID-19
  • Health Care Worker
  • Hydroxychloroquine

Interventions

DRUG

Hydroxychloroquine Pre-Exposure Prophylaxis

HCQ PreP 400mg daily

DRUG

Placebo oral tablet

Placebo tablets 400mg daily

Sponsors & Collaborators

  • GeoSentinel Foundation

    lead OTHER

Principal Investigators

  • Bradley A Connor, MD · Dr. Bradley A. Connor

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-24
Primary Completion
2020-06-24
Completion
2020-08-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04352946 on ClinicalTrials.gov