Military COVID-19 Hydroxychloroquine Pre-exposure and Post-exposure Prophylaxis Study

• Status: Not yet recruiting
• Trial end date: 2020-08-01
• Target enrollment: 1450
• Participant gender: All

Summary

There is significant interest throughout the United States in performing a well-designed study to evaluate whether there is value in using Hydroxychloroquine or Chloroquine as a pre-exposure prophylaxis or post-exposure prophylaxis regimen for COVID-19 patients and at risk personnel.

We have designed a prospective double blinded randomized controlled clinical trial to answer just this question.

The study will consist of 4 arms:

1. A placebo control arm of 450 patients

2. A low dose prophylaxis arm of 450 patients treated with 200mg Hydroxychloroquine daily

3. A high dose prophylaxis arm of 450 patients treated with 400mg Hydroxychloroquine daily

4. A post-exposure arm of 100 patients treated with 400mg Hydroxychloroquine daily for 7 days.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: United States Department of Defense
• Treatments: Hydroxychloroquine

Criteria

Inclusion Criteria:

All mission critical personnel enrolled to the DiLorenzo Tricare Health Clinic or Pentagon Flight Medicine Clinic unable to telework or appropriately socially distance with access to the Pentagon during the declared public health crisis.

Exclusion Criteria:

Known recovered COVID-19 patient, G6PD deficient individuals, individuals with significant QT abnormalities, non-compliant patients, and patients who refuse randomization or consent.