Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE April 1, 2020
First Posted Date  ICMJE April 2, 2020
Last Update Posted Date February 16, 2021
Actual Study Start Date  ICMJE April 3, 2020
Actual Primary Completion Date June 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
  • 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.
  • 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.
  • 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.
  • Risk ratio for the different clinical, analytical and microbiological conditions to develop COVID-19 [ Time Frame: Up to 6 months after start of treatment ]
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic
Official Title  ICMJE Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic: A Multicentre, Double-Blinded Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: Hydroxychloroquine
  • 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
    Intervention: Drug: Placebos
Publications * Grau-Pujol B, Camprubí D, Marti-Soler H, Fernández-Pardos M, Guinovart C, Muñoz 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2021)
275
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2020)
440
Actual Study Completion Date  ICMJE December 31, 2020
Actual Primary Completion Date June 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04331834
Other Study ID Numbers  ICMJE PrEP_COVID
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Barcelona Institute for Global Health
Study Sponsor  ICMJE Barcelona Institute for Global Health
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Jose Muñoz Gutiérrez, MD, PhD Barcelona Institute for Global Health
PRS Account Barcelona Institute for Global Health
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP