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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318015
Recruitment Status : Completed
First Posted : March 23, 2020
Last Update Posted : February 1, 2022
Sponsor:
Information provided by (Responsible Party):
National Institute of Respiratory Diseases, Mexico

Study Description
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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
COVID-19 Severe Acute Respiratory Syndrome Drug: Hydroxychloroquine Drug: Placebo oral tablet 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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 289 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Triple 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 : April 14, 2020
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. Symptomatic COVID-19 infection rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318015


Locations
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Mexico
Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"
Mexico, City, Mexico, 14080
Sponsors and Collaborators
National Institute of Respiratory Diseases, Mexico
Investigators
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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
More Information
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Responsible Party: National Institute of Respiratory Diseases, Mexico
ClinicalTrials.gov Identifier: NCT04318015    
Other Study ID Numbers: ProfilaxisCOVID
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: February 1, 2022
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Severe Acute Respiratory Syndrome
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Lung Diseases
Respiratory Tract Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents