Clinical trial NCT04331834: Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Keywords: PrEP
hydroxychloroquine
prophylaxis
pre-exposure
healthcare workers
Lead sponsor: Barcelona Institute for Global Health
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
name: Laboratorios Rubió
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Hospital Plató
name: Hospital de Granollers
First posted: 2020-04-02
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Confirmed cases of a COVID-19
timeFrame: Up to 6 months after start of treatment
Secondary outcomes:
measure: SARS-CoV-2 seroconversion
timeFrame: Up to 6 months after start of treatment
measure: Occurrence of any adverse event related with hydroxychloroquine treatment
timeFrame: Up to 6 months after start of treatment
measure: Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers
timeFrame: Up to 6 months after start of treatment
measure: Risk ratio for the different clinical, analytical and microbiological conditions to develop COVID-19
timeFrame: Up to 6 months after start of treatment
measure: COVID-19 Biobank
timeFrame: Up to 6 months after start of treatment
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: ISGlobal
Study officials:
affiliation: Barcelona Institute for Global Health
name: Jose Muñoz Gutiérrez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.