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.
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
All treatment will be administered orally.
Other Name: Plaquenil
Drug: Placebo oral tablet
All placebo will be administered orally
Other Name: Placebo
- 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.
- 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)
Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"
Mexico, City, Mexico