Official Title
Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic: A Multicentre, Double-Blinded Randomized Controlled Trial
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.

Completed
COVID-19

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

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Spain
Locations

ISGlobal
Barcelona, Spain

Jose Muñoz Gutiérrez, MD, PhD, Principal Investigator
Barcelona Institute for Global Health

Barcelona Institute for Global Health
NCT Number
Keywords
PrEP
hydroxychloroquine
prophylaxis
pre-exposure
Healthcare Workers
MeSH Terms
COVID-19
Hydroxychloroquine