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

National Institute of Respiratory Diseases, Mexico289 enrolled

Overview

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 60 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

289

Conditions

COVID-19 Severe Acute Respiratory Syndrome

Interventions

HydroxychloroquineDRUG

All treatment will be administered orally.

Placebo oral tabletDRUG

All placebo will be administered orally

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"

Mexico City, Mexico

Outcomes

Primary Outcomes

Symptomatic COVID-19 infection rate

Symptomatic infection rate by COVID-19 defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive COVID-19 real-time polymerase chain reaction test.

Time frame: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start

Secondary Outcomes

Symptomatic non-COVID viral infection rate

Symptomatic infection rate by other non-COVID-19 viral etiologies defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive viral real time polymerase chain reaction test.

Time frame: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start

Days of labor absenteeism

Number of days absent from labor due to COVID-19 symptomatic infection

Time frame: From date of randomization until study completion 60 days after treatment start

Rate of labor absenteeism

Absenteeism from labor rate due to COVID-19 symptomatic infection

Time frame: From date of randomization until study completion 60 days after treatment start

Rate of severe respiratory COVID-19 disease in healthcare personnel

Time frame: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start

Data from ClinicalTrials.gov

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