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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Hydroxychloroquine
Placebos
Sponsored by
Barcelona Institute for Global Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring PrEP, hydroxychloroquine, prophylaxis, pre-exposure, healthcare workers

Eligibility Criteria

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

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.

Sites / Locations

  • ISGlobal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pre-exposure prophylaxis of SARS-CoV-2

Control group with placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Confirmed cases of a COVID-19
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

SARS-CoV-2 seroconversion
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.
Occurrence of any adverse event related with hydroxychloroquine treatment
Incidence of clinical and/or laboratory adverse events will be compared in the PrEP group and in the placebo arm.
Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers
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.
Risk ratio for the different clinical, analytical and microbiological conditions to develop COVID-19
COVID-19 Biobank
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.

Full Information

First Posted
April 1, 2020
Last Updated
April 28, 2023
Sponsor
Barcelona Institute for Global Health
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
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1. Study Identification

Unique Protocol Identification Number
NCT04331834
Brief Title
Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic
Acronym
PrEP_COVID
Official Title
Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic: A Multicentre, Double-Blinded Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 3, 2020 (Actual)
Primary Completion Date
June 25, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barcelona Institute for Global Health
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

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
PrEP, hydroxychloroquine, prophylaxis, pre-exposure, healthcare workers

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
275 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-exposure prophylaxis of SARS-CoV-2
Arm Type
Experimental
Arm Description
Participants will receive hydroxychloroquine 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months
Arm Title
Control group with placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
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
Intervention Name(s)
Placebos
Intervention Description
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 Measure Information:
Title
Confirmed cases of a COVID-19
Description
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.
Time Frame
Up to 6 months after start of treatment
Secondary Outcome Measure Information:
Title
SARS-CoV-2 seroconversion
Description
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.
Time Frame
Up to 6 months after start of treatment
Title
Occurrence of any adverse event related with hydroxychloroquine treatment
Description
Incidence of clinical and/or laboratory adverse events will be compared in the PrEP group and in the placebo arm.
Time Frame
Up to 6 months after start of treatment
Title
Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers
Description
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.
Time Frame
Up to 6 months after start of treatment
Title
Risk ratio for the different clinical, analytical and microbiological conditions to develop COVID-19
Time Frame
Up to 6 months after start of treatment
Title
COVID-19 Biobank
Description
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.
Time Frame
Up to 6 months after start of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Muñoz Gutiérrez, MD, PhD
Organizational Affiliation
Barcelona Institute for Global Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
ISGlobal
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34781981
Citation
Grau-Pujol B, Camprubi-Ferrer D, Marti-Soler H, Fernandez-Pardos M, Carreras-Abad C, Andres MV, Ferrer E, Muelas-Fernandez M, Jullien S, Barilaro G, Ajanovic S, Vera I, Moreno L, Gonzalez-Redondo E, Cortes-Serra N, Roldan M, Arcos AA, Mur I, Domingo P, Garcia F, Guinovart C, Munoz J. Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized clinical trial. Trials. 2021 Nov 15;22(1):808. doi: 10.1186/s13063-021-05758-9.
Results Reference
derived
PubMed Identifier
32727613
Citation
Grau-Pujol B, Camprubi D, Marti-Soler H, Fernandez-Pardos M, Guinovart C, Munoz J. Pre-exposure prophylaxis with hydroxychloroquine for high-risk healthcare workers during the COVID-19 pandemic: A structured summary of a study protocol for a multicentre, double-blind randomized controlled trial. Trials. 2020 Jul 29;21(1):688. doi: 10.1186/s13063-020-04621-7.
Results Reference
derived

Learn more about this trial

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

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