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

Sponsor
National Institute of Respiratory Diseases, Mexico (Other)
Overall Status
Completed
CT.gov ID
NCT04318015
Collaborator
(none)
289
Enrollment
1
Location
4
Arms
11.5
Actual Duration (Months)
25.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
289 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Triple blinded, randomized controlled trialTriple blinded, randomized controlled trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Prevention
Official Title:
Chemoprophylaxis With Hydroxychloroquine in Healthcare Personnel in Contact With COVID-19 Patients: A Randomized Controlled Trial (PHYDRA Trial)
Actual Study Start Date :
Apr 14, 2020
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Mar 31, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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

    3. 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

    4. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas" Mexico, City Mexico 14080

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Institute of Respiratory Diseases, Mexico
    ClinicalTrials.gov Identifier:
    NCT04318015
    Other Study ID Numbers:
    • ProfilaxisCOVID
    First Posted:
    Mar 23, 2020
    Last Update Posted:
    Feb 1, 2022
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Severe Acute Respiratory Syndrome
    Hydroxychloroquine

    Study Results

    No Results Posted as of Feb 1, 2022