Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT04331834
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04331834
Study Brief:
Protocol Section:
NCT04331834