The investigators aim to evaluate the efficacy of pre-exposure prophylaxis with hydroxychloroquine in healthcare workers with high-risk of SARS-CoV-2 infection.
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
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.
ISGlobal
Barcelona, Spain
Jose Muñoz Gutiérrez, MD, PhD, Principal Investigator
Barcelona Institute for Global Health