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

NCT04331834 | Completed Phase 3

• 1 other identifier: PrEP_COVID
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

PrEP; hydroxychloroquine; prophylaxis; pre-exposure; healthcare workers

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 6 months after start of treatment

Secondary Outcomes (5)

• SARS-CoV-2 seroconversion

  Up to 6 months after start of treatment

• Occurrence of any adverse event related with hydroxychloroquine treatment

  Up to 6 months after start of treatment

• Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers

  Up to 6 months after start of treatment

• Risk ratio for the different clinical, analytical and microbiological conditions to develop COVID-19

  Up to 6 months after start of treatment

• COVID-19 Biobank

  Up to 6 months after start of treatment

Study Arms (2)

Pre-exposure prophylaxis of SARS-CoV-2

EXPERIMENTAL

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

Drug: Hydroxychloroquine

Control group with placebo

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

Hydroxychloroquine 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

Pre-exposure prophylaxis of SARS-CoV-2

Placebos 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

Control group with placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barcelona Institute for Global Health: lead
• Hospital Clinic of Barcelona: collaborator
• Laboratorios Rubió: collaborator
• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: collaborator
• Hospital Plató: collaborator
• Hospital de Granollers: collaborator

Study Sites (1)

ISGlobal

Barcelona, 08036, Spain

Location

Related Publications (2)

• 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.

  PMID: 34781981 DERIVED

• 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.

  PMID: 32727613 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jose Muñoz Gutiérrez, MD, PhD

  Barcelona Institute for Global Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 2, 2020
• Study Start: April 3, 2020
• Primary Completion: June 25, 2020
• Study Completion: December 31, 2020
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)