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

NCT04318015 | Completed Phase 3 DMC

• 1 other identifier: ProfilaxisCOVID
• Study Type: interventional
• Target: 289
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Symptomatic non-COVID viral infection rate

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

• Days of labor absenteeism

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

• Rate of labor absenteeism

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

• 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

Study Arms (4)

High-risk Treatment

EXPERIMENTAL

Hydroxychloroquine 200mg per day for 60 days.

Drug: Hydroxychloroquine

High-risk Placebo

PLACEBO COMPARATOR

Placebo tablet per day for 60 days.

Drug: Placebo oral tablet

Low-risk Treatment

EXPERIMENTAL

Hydroxychloroquine 200mg per day for 60 days

Drug: Hydroxychloroquine

Low-risk Placebo

PLACEBO COMPARATOR

Placebo tablet per day for 60 days.

Drug: Placebo oral tablet

Interventions

Hydroxychloroquine DRUG

All treatment will be administered orally.

Also known as: Plaquenil

High-risk Treatment; Low-risk Treatment

Placebo oral tablet DRUG

All placebo will be administered orally

Also known as: Placebo

High-risk Placebo; Low-risk Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Institute of Respiratory Diseases, Mexico: lead

Study Sites (1)

Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"

Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jorge Rojas-Serrano, MD, PhD.

  National Institute of Respiratory Diseases - México

  PRINCIPAL INVESTIGATOR

• Rogelio Perez-Padilla, MD

  National Institute of Respiratory Diseases - México

  STUDY DIRECTOR

• Felipe Jurado-Camacho, MD. MSc

  National Institute of Respiratory Diseases - México

  STUDY DIRECTOR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will happen after previous assignment of recruited individual to high-risk or low-risk exposure according to he or her activities. An independent member of the team will randomly assign treatment or placebo following a computer based program. Blinding will end in case elimination criteria are met.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Triple blinded, randomized controlled trial

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 23, 2020
• Study Start: April 14, 2020
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2021
• Last Updated: February 1, 2022

Record last verified: 2020-04

Locations

ME (1)