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

• Status: Completed
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Barcelona Institute for Global Health
• Collaborators: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Hospital Clinic of Barcelona; Hospital de Granollers; Hospital Plató; Laboratorios Rubió
• Treatments: Hydroxychloroquine

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.