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

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ClinicalTrials.gov Identifier: NCT04318015
Recruitment Status : Recruiting
First Posted : March 23, 2020
Last Update Posted : April 17, 2020
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
National Institute of Respiratory Diseases, Mexico

Tracking Information
First Submitted Date  ICMJE March 19, 2020
First Posted Date  ICMJE March 23, 2020
Last Update Posted Date April 17, 2020
Actual Study Start Date  ICMJE April 14, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2020)
  • 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.
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hydroxychloroquine Chemoprophylaxis in Healthcare Personnel in Contact With COVID-19 Patients (PHYDRA Trial)
Official Title  ICMJE Chemoprophylaxis With Hydroxychloroquine in Healthcare Personnel in Contact With COVID-19 Patients: A Randomized Controlled Trial (PHYDRA Trial)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • COVID-19
  • Severe Acute Respiratory Syndrome
Intervention  ICMJE
  • Drug: Hydroxychloroquine
    All treatment will be administered orally.
    Other Name: Plaquenil
  • Drug: Placebo oral tablet
    All placebo will be administered orally
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: High-risk Treatment
    Hydroxychloroquine 200mg per day for 60 days.
    Intervention: Drug: Hydroxychloroquine
  • Placebo Comparator: High-risk Placebo
    Placebo tablet per day for 60 days.
    Intervention: Drug: Placebo oral tablet
  • Experimental: Low-risk Treatment
    Hydroxychloroquine 200mg per day for 60 days
    Intervention: Drug: Hydroxychloroquine
  • Placebo Comparator: Low-risk Placebo
    Placebo tablet per day for 60 days.
    Intervention: Drug: Placebo oral tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 19, 2020)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Felipe Camacho-Jurado, MD +52 55871700 ext 5305 lfjcamacho@comunidad.unam.mx
Contact: Rogelio Perez-Padilla, MD. PhD. +52 55871700 ext 5305 perezpad@gmail.com
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04318015
Other Study ID Numbers  ICMJE ProfilaxisCOVID
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party National Institute of Respiratory Diseases, Mexico
Study Sponsor  ICMJE National Institute of Respiratory Diseases, Mexico
Collaborators  ICMJE Sanofi
Investigators  ICMJE
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
PRS Account National Institute of Respiratory Diseases, Mexico
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP