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

Phase 3

Completed

• Conditions: Severe Acute Respiratory Syndrome; COVID-19
• Interventions: Drug: Placebo oral tablet; Drug: Hydroxychloroquine

• Registration Number: NCT04318015
• Lead Sponsor: National Institute of Respiratory Diseases, Mexico

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.

Study Timeline

• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-23
• Status Verified: 2020-04
• Study Start: 2020-04-14
• Primary Completion: 2020-12-31
• Study Completion: 2021-03-31
• Last Update Submitted: 2022-01-17
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 289

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-risk Placebo	Placebo oral tablet	Placebo tablet per day for 60 days.
Low-risk Placebo	Placebo oral tablet	Placebo tablet per day for 60 days.
High-risk Treatment	Hydroxychloroquine	Hydroxychloroquine 200mg per day for 60 days.
Low-risk Treatment	Hydroxychloroquine	Hydroxychloroquine 200mg per day for 60 days

Primary Outcome Measures

Name	Time	Method
Symptomatic COVID-19 infection rate	From date of randomization until the appearance of symptoms or study completion 60 days after treatment start	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.

Secondary Outcome Measures

Name	Time	Method
Days of labor absenteeism	From date of randomization until study completion 60 days after treatment start	Number of days absent from labor due to COVID-19 symptomatic infection
Rate of labor absenteeism	From date of randomization until study completion 60 days after treatment start	Absenteeism from labor rate due to COVID-19 symptomatic infection
Rate of severe respiratory COVID-19 disease in healthcare personnel	From date of randomization until the appearance of symptoms or study completion 60 days after treatment start	Rate of severe respiratory COVID-19 disease in healthcare personnel
Symptomatic non-COVID viral infection rate	From date of randomization until the appearance of symptoms or study completion 60 days after treatment start	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.

Trial Locations

Locations (1)

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