Hydroxychloroquine Chemoprophylaxis in Healthcare Personnel in Contact With COVID-19 Patients (PHYDRA Trial)

• Status: Recruiting
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: All

Summary

Triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) aiming to prove hydroxychloroquine's security and efficacy as prophylaxis treatment for healthcare personnel exposed to COVID-19 patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Respiratory Diseases, Mexico
• Collaborator: Sanofi
• Treatments: Hydroxychloroquine

Criteria

Inclusion Criteria:

• 18 years old upon study start

• Healthcare personnel exposed to patients with COVID-19 respiratory disease:

physicians, nurses, chemists, pharmacists, janitors, stretcher-bearer, administrative and respiratory therapists.

• Signed consent for randomization to any study arm.

Exclusion Criteria:

• Known hypersensitivity to hydroxychloroquine manifested as anaphylaxis

• Current treatment to chloroquine or hydroxychloroquine

• Women with last menstruation date farther than a month without negative pregnancy test.

• Women with positive pregnancy test

• Breastfeeding women

• Chronic hepatic disease history (Child-Pugh B or C)

• Chronic renal disease (GFR less or equal to 30)