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

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

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.

Study Overview

• Status: Completed
• Conditions: Severe Acute Respiratory Syndrome; COVID-19
• Intervention / Treatment: Drug: Hydroxychloroquine; Drug: Placebo oral tablet

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 Type: Interventional
• Enrollment (Actual): 289
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Mexico, City, Mexico, 14080
    • Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-risk Treatment; Hydroxychloroquine 200mg per day for 60 days.	Drug: Hydroxychloroquine; All treatment will be administered orally.; Other Names: Plaquenil
Placebo Comparator: High-risk Placebo; Placebo tablet per day for 60 days.	Drug: Placebo oral tablet; All placebo will be administered orally; Other Names: Placebo
Experimental: Low-risk Treatment; Hydroxychloroquine 200mg per day for 60 days	Drug: Hydroxychloroquine; All treatment will be administered orally.; Other Names: Plaquenil
Placebo Comparator: Low-risk Placebo; Placebo tablet per day for 60 days.	Drug: Placebo oral tablet; All placebo will be administered orally; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From date of randomization until the appearance of symptoms or study completion 60 days after treatment start

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	From date of randomization until study completion 60 days after treatment start
Rate of severe respiratory COVID-19 disease in healthcare personnel	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

Collaborators and Investigators

• Sponsor: National Institute of Respiratory Diseases, Mexico
• Investigators: Principal Investigator: Jorge Rojas-Serrano, MD, PhD., National Institute of Respiratory Diseases - México; Study Director: Rogelio Perez-Padilla, MD, National Institute of Respiratory Diseases - México; Study Director: Felipe Jurado-Camacho, MD. MSc, National Institute of Respiratory Diseases - México; Study Chair: Ireri Thirion-Romero, MD, MSc, National Institute of Respiratory Diseases - México; Study Chair: Sebastian Rodríguez-Llamazares, MD, MPH, National Institute of Respiratory Diseases - México; Study Chair: Carmen Hernandez Cárdenas, MD, MSc, National Institute of Respiratory Diseases - México; Study Chair: Cristobal Guadarrama-Pérez, MD, National Institute of Respiratory Diseases - México; Study Chair: Alejandra Ramírez-Venegas, MD, MSc, National Institute of Respiratory Diseases - México

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: March 19, 2020
• First Posted (Actual): March 23, 2020

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Hydroxychloroquine
• Other Study ID Numbers: ProfilaxisCOVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No