Status:
COMPLETED
Hydroxychloroquine Chemoprophylaxis in Healthcare Personnel in Contact With COVID-19 Patients (PHYDRA Trial)
Lead Sponsor:
National Institute of Respiratory Diseases, Mexico
Conditions:
COVID-19
Severe Acute Respiratory Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 t...
Detailed Description
Healthcare personnel infection with COVID-19 is a major setback in epidemiological emergencies. Hydroxychloroquine has proven to inhibit coronavirus in-vitro but no data to date has proven in-vivo eff...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
289 Patients enrolled
Trial Details
Trial ID
NCT04318015
Start Date
April 14 2020
End Date
March 31 2021
Last Update
February 1 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"
Mexico City, Mexico, 14080