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

National Institute of Respiratory Diseases, Mexico

Status and phase: Completed; Phase 3

Conditions: COVID-19; Severe Acute Respiratory Syndrome

Treatments: Drug: Placebo oral tablet; Drug: Hydroxychloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT04318015

ProfilaxisCOVID

Details and patient eligibility

About

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.

Full 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.

Enrollment: 289 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

289 participants in 4 patient groups, including a placebo group

High-risk Treatment

Experimental group

Description:

Hydroxychloroquine 200mg per day for 60 days.

Treatment:

Drug: Hydroxychloroquine

High-risk Placebo

Placebo Comparator group

Description:

Placebo tablet per day for 60 days.

Treatment:

Drug: Placebo oral tablet

Low-risk Treatment

Experimental group

Description:

Hydroxychloroquine 200mg per day for 60 days

Treatment:

Drug: Hydroxychloroquine

Low-risk Placebo

Placebo Comparator group

Description:

Placebo tablet per day for 60 days.

Treatment:

Drug: Placebo oral tablet