Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic

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

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-03

Study Completion Date

2020-12-31

Brief Summary

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The investigators aim to evaluate the efficacy of pre-exposure prophylaxis with hydroxychloroquine in healthcare workers with high-risk of SARS-CoV-2 infection.

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Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pre-exposure prophylaxis of SARS-CoV-2

Participants will receive hydroxychloroquine 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

Hydroxychloroquine with the following dosage:

* day 0: 400 mg (2 tablets)
* day 1: 400 mg (2 tablets)
* day 2: 400 mg (2 tablets)
* day 3: 400 mg (2 tablets)
* weekly: 400 mg (2 tablets) for a period of six months

Control group with placebo

Participants will receive placebo 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Placebo with the following dosage:

* day 0: 400 mg (2 tablets)
* day 1: 400 mg (2 tablets)
* day 2: 400 mg (2 tablets)
* day 3: 400 mg (2 tablets)
* weekly: 400 mg (2 tablets) for a period of six months

Interventions

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Hydroxychloroquine

Hydroxychloroquine with the following dosage:

* day 0: 400 mg (2 tablets)
* day 1: 400 mg (2 tablets)
* day 2: 400 mg (2 tablets)
* day 3: 400 mg (2 tablets)
* weekly: 400 mg (2 tablets) for a period of six months

Intervention Type DRUG

Placebos

Placebo with the following dosage:

* day 0: 400 mg (2 tablets)
* day 1: 400 mg (2 tablets)
* day 2: 400 mg (2 tablets)
* day 3: 400 mg (2 tablets)
* weekly: 400 mg (2 tablets) for a period of six months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Negative PCR and negative serology on day 0
* Healthcare worker at any of the trial sites
* Female participants: negative for pregnancy test
* Willing to participate in the study
* Able to sign the informed consent form

Exclusion Criteria

* Age \<18 years
* Pregnancy or breastfeeding
* Ongoing antiviral or antiretroviral treatment or HIV positive
* Ongoing anti-inflammatory treatment (corticosteroids)
* Ongoing or previous (1 month) chloroquine or hydroxychloroquine treatment
* Confirmed case of SARS-CoV-2 infection (positive PCR) at day 0
* Positive serology for SARS-CoV-1 infection at day 0
* Impossibility of signing the informed consent form
* Rejection of participation
* Working less than 3 days a week in the Hospital Clinic of Barcelona.
* Any contraindication for hydroxychloroquine treatment:

* Hydroxychloroquine hypersensitivity or 4-aminoquinoline hypersensitivity
* Retinopathy, visual field or visual acuity disturbances
* QT prolongation, bradycardia (\<50bpm), ventricular tachycardia, other arrhythmias, as determined on day 0 ECG or medical history
* Potassium \< 3 mEq/L or AST or ALT \> 5 upper normal limit, as determined on day 0 blood test
* Previous myocardial infarction
* Myasthenia gravis
* Porphyria
* Glomerular clearance \< 10ml/min
* Previous history of severe hypoglycaemia
* Ongoing treatment with antimalarials, antiarrhythmic, tricyclic antidepressants, selective serotonin reuptake inhibitors, natalizumab, quinolones, macrolides, agalsidase alfa and beta.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes