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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

289 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-14

Study Completion Date

2021-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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COVID-19 Severe Acute Respiratory Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Triple blinded, randomized controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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High-risk Treatment

Hydroxychloroquine 200mg per day for 60 days.

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

All treatment will be administered orally.

High-risk Placebo

Placebo tablet per day for 60 days.

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

All placebo will be administered orally

Low-risk Treatment

Hydroxychloroquine 200mg per day for 60 days

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

All treatment will be administered orally.

Low-risk Placebo

Placebo tablet per day for 60 days.

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

All placebo will be administered orally

Interventions

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Hydroxychloroquine

All treatment will be administered orally.

Intervention Type DRUG

Placebo oral tablet

All placebo will be administered orally

Intervention Type DRUG

Other Intervention Names

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Plaquenil Placebo

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR