Prevention of novel Coronavirus infection with hydroxychloroquine

Phase 1

• Conditions: COVID-19; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001565-37-ES
• Lead Sponsor: ISGlobal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-07
• Last Update Posted: 14 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

- Age = 18 years
- Negative PCR and negative serology at day 0
- Healthcare worker at Hospital Clinic of Barcelona
- Female participants: negative for pregnancy test
- Willing to participate in the study
- Able to sign the informed consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 435
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Age <18 years
- Pregnancy or breastfeeding
- Ongoing antiviral or antiretroviral treatment or HIV positive
- Ongoing anti inflammatory treatment (NSAID, corticosteroids)
- Ongoing 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 5 days a week in the Hospital Clinic of Barcelona.
- Any contraindication for hydroxychloroquine treatment (9):
o Hydroxychloroquine hypersensitivity or 4-aminoquinoline hypersensitivity
o Retinopathy, visual field or visual acuity disturbances
o QT prolongation, bradycardia (<50bpm), ventricular tachycardia, other arrhythmia, as determined on day 0 ECG or medical history
o Potassium < 3 mEq/L or AST or ALT > 5 upper normal limit, as determined on day 0 blood test
o Previous myocardial infarction
o Myasthenia gravis
o Psoriasis or porphyria
o Glomerular clearance < 10ml/min
o Previous history of severe hypoglycaemia
o Ongoing treatment with: antimalarials, antiarrhythmic, tricyclic antidepressants, natalizumab, quinolones, macrolides, agalsidase alfa and beta.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified