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Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2

NCT04308668 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1312

Last updated 2021-05-13

Study results available
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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.

Conditions

  • Corona Virus Infection
  • Acute Respiratory Distress Syndrome
  • SARS-CoV Infection
  • Coronavirus
  • Coronavirus Infections

Interventions

DRUG

Hydroxychloroquine

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

OTHER

Placebo

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

Sponsors & Collaborators

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    collaborator OTHER

  • University of Manitoba

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • University of Minnesota

    lead OTHER

Principal Investigators

  • David Boulware, MD, MPH · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-17
Primary Completion
2020-05-20
Completion
2020-05-20
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

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 NCT04308668 on ClinicalTrials.gov