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NCT Number: NCT04318015

Hydroxychloroquine Chemoprophylaxis in Healthcare Personnel in Contact With COVID-19 Patients (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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"

Mexico City, 14080, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hydroxychloroquine

Drug

All treatment will be administered orally.

Other names: Plaquenil

Placebo oral tablet

Drug

All placebo will be administered orally

Other names: Placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

National Institute of Respiratory Diseases, Mexico

Other Gov

Registry information

Official study title

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

Acronym: PHYDRA

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Mar 23, 2020
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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