Status:
COMPLETED
Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic
Lead Sponsor:
Barcelona Institute for Global Health
Collaborating Sponsors:
Hospital Clinic of Barcelona
Laboratorios Rubió
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
- 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
- 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.
Key Trial Info
Start Date :
April 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT04331834
Start Date
April 3 2020
End Date
December 31 2020
Last Update
May 1 2023
Active Locations (1)
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1
ISGlobal
Barcelona, Spain, 08036