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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04331834
Recruitment Status : Recruiting
First Posted : April 2, 2020
Last Update Posted : April 7, 2020
Sponsor:
Collaborators:
Hospital Clinic of Barcelona
Laboratorios Rubió
Information provided by (Responsible Party):
Barcelona Institute for Global Health

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 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 Unicentric, Double-Blinded Randomized Controlled Trial
Actual Study Start Date : April 3, 2020
Estimated Primary Completion Date : October 3, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


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




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 symptoms compatible with COVID-19 and/or a positive PCR for SARS-CoV-2) 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 at 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 at day 0
  • Healthcare worker at Hospital Clínic de Barcelona
  • 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 (NSAID, corticosteroids)
  • Ongoing 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 5 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
    • Psoriasis or porphyria
    • Glomerular clearance < 10ml/min
    • Previous history of severe hypoglycaemia
    • Ongoing treatment with: antimalarials, antiarrhythmic, tricyclic antidepressants, natalizumab, quinolones, macrolides, agalsidase alfa and beta.

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 Recruiting
Barcelona, Spain, 08036
Contact: Jose F Muñoz Gutiérrez, MD, PhD    608774071    jose.munoz@isglobal.org   
Contact: Marc Fernández Pardos, MSc    618868720    marc.fernandez@isglobal.org   
Sponsors and Collaborators
Barcelona Institute for Global Health
Hospital Clinic of Barcelona
Laboratorios Rubió
Investigators
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Principal Investigator: Jose Muñoz Gutiérrez, MD, PhD Barcelona Institute for Global Health
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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: April 7, 2020
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
Additional relevant MeSH terms:
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Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents