NCT04318015

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

Chemoprophylaxis With Hydroxychloroquine in Healthcare Personnel in Contact With COVID-19 Patients: A Randomized Controlled Trial (PHYDRA Trial)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 289 (actual)
• Sponsor: National Institute of Respiratory Diseases, Mexico · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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 effects. Nevertheless, hydroxychloroquine is a low cost, limited toxicity and broadly used agent. Since there is currently no treatment for COVID-19 exposure prophylaxis, the investigators will implement a triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) for 60 days.

Conditions

• COVID-19
• Severe Acute Respiratory Syndrome

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	All treatment will be administered orally.
DRUG	Placebo oral tablet	All placebo will be administered orally

Timeline

• Start date: 2020-04-14
• Primary completion: 2020-12-31
• Completion: 2021-03-31
• First posted: 2020-03-23
• Last updated: 2022-02-01

Locations

1 site across 1 country: Mexico