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

Primary Purpose

COVID-19, Severe Acute Respiratory Syndrome

Status

Completed

Phase

Phase 3

Locations

Mexico

Study Type

Interventional

Intervention

Hydroxychloroquine

Placebo oral tablet

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

High-risk Treatment

High-risk Placebo

Low-risk Treatment

Low-risk Placebo

Arm Description

Hydroxychloroquine 200mg per day for 60 days.

Placebo tablet per day for 60 days.

Hydroxychloroquine 200mg per day for 60 days

Placebo tablet per day for 60 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Symptomatic non-COVID viral infection rate

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

Number of days absent from labor due to COVID-19 symptomatic infection

Rate of labor absenteeism

Absenteeism from labor rate due to COVID-19 symptomatic infection

Rate of severe respiratory COVID-19 disease in healthcare personnel

Full Information

NCT ID

NCT04318015

First Posted

March 19, 2020

Last Updated

January 17, 2022

Sponsor

National Institute of Respiratory Diseases, Mexico

1. Study Identification

Unique Protocol Identification Number

NCT04318015

Brief Title

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

Acronym

PHYDRA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

April 14, 2020 (Actual)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Respiratory Diseases, Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, Severe Acute Respiratory Syndrome

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Triple blinded, randomized controlled trial

Masking

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

289 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High-risk Treatment

Arm Type

Experimental

Arm Description

Hydroxychloroquine 200mg per day for 60 days.

Arm Title

High-risk Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo tablet per day for 60 days.

Arm Title

Low-risk Treatment

Arm Type

Experimental

Arm Description

Hydroxychloroquine 200mg per day for 60 days

Arm Title

Low-risk Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo tablet per day for 60 days.

Intervention Type

Drug

Intervention Name(s)

Hydroxychloroquine

Other Intervention Name(s)

Plaquenil

Intervention Description

All treatment will be administered orally.

Intervention Type

Drug

Intervention Name(s)

Placebo oral tablet

Other Intervention Name(s)

Placebo

Intervention Description

All placebo will be administered orally

Primary Outcome Measure Information:

Title

Symptomatic COVID-19 infection rate

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Symptomatic non-COVID viral infection rate

Description

Time Frame

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

Title

Days of labor absenteeism

Description

Number of days absent from labor due to COVID-19 symptomatic infection

Time Frame

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

Title

Rate of labor absenteeism

Description

Absenteeism from labor rate due to COVID-19 symptomatic infection

Time Frame

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

Title

Rate of severe respiratory COVID-19 disease in healthcare personnel

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jorge Rojas-Serrano, MD, PhD.

Organizational Affiliation