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

Severe Acute Respiratory Syndrome

Drug: Hydroxychloroquine

All treatment will be administered orally.
Other Name: Plaquenil

Drug: Placebo oral tablet

All placebo will be administered orally
Other Name: Placebo

Eligibility 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

- 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)

Eligibility Gender
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A

Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"
Mexico, City, Mexico

National Institute of Respiratory Diseases, Mexico
NCT Number
MeSH Terms
Severe Acute Respiratory Syndrome