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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04331834
Recruitment Status : Completed
First Posted : April 2, 2020
Last Update Posted : February 16, 2021
Sponsor:
Collaborators:
Hospital Clinic of Barcelona
Laboratorios Rubió
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Hospital Plató
Hospital de Granollers
Information provided by (Responsible Party):
Barcelona Institute for Global Health

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

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Hydroxychloroquine Drug: Placebos Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 275 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic: A Multicentre, Double-Blinded Randomized Controlled Trial
Actual Study Start Date : April 3, 2020
Actual Primary Completion Date : June 25, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Drug: 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
Placebo Comparator: Control group with placebo
Participants will receive placebo 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months
 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


Outcome Measures
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Primary Outcome Measures :
  1. Confirmed cases of a COVID-19 [ Time Frame: Up to 6 months after start of treatment ]
    Confirmed cases of a COVID-19 (defined by a positive PCR for SARS-CoV-2 or symptoms compatible with COVID-19 with seroconversion) in the PrEP group compared to the placebo group at any time during the 6 months of the follow-up in healthcare workers with negative PCR for SARS-CoV-2 on day 0 and negative serology for SARS-CoV-2 on day 0.


Secondary Outcome Measures :
  1. SARS-CoV-2 seroconversion [ Time Frame: Up to 6 months after start of treatment ]
    SARS-CoV-2 seroconversion in the PrEP group compared to placebo in during 6 months of follow-up in healthcare workers with negative serology at day 0.

  2. Occurrence of any adverse event related with hydroxychloroquine treatment [ Time Frame: Up to 6 months after start of treatment ]
    Incidence of clinical and/or laboratory adverse events will be compared in the PrEP group and in the placebo arm.

  3. Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers [ Time Frame: Up to 6 months after start of treatment ]
    Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers will be estimated by the number of healthcare workers diagnosed with COVID-19 in the placebo group, among the total of healthcare workers included in the non-PrEP group during the study period.

  4. Risk ratio for the different clinical, analytical and microbiological conditions to develop COVID-19 [ Time Frame: Up to 6 months after start of treatment ]
  5. COVID-19 Biobank [ Time Frame: Up to 6 months after start of treatment ]
    A repository (biobank) of serum samples obtained from healthcare workers confirmed COVID-19 cases for future research on blood markers to predict SARS-CoV-2 infection.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04331834


Locations
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Spain
ISGlobal
Barcelona, Spain, 08036
Sponsors and Collaborators
Barcelona Institute for Global Health
Hospital Clinic of Barcelona
Laboratorios Rubió
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Hospital Plató
Hospital de Granollers
Investigators
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Principal Investigator: Jose Muñoz Gutiérrez, MD, PhD Barcelona Institute for Global Health
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Barcelona Institute for Global Health
ClinicalTrials.gov Identifier: NCT04331834    
Other Study ID Numbers: PrEP_COVID
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Barcelona Institute for Global Health:
PrEP
hydroxychloroquine
prophylaxis
pre-exposure
healthcare workers
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Lung Diseases
Respiratory Tract Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents