COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001565-37/ES

ISGlobal - Jose Muñoz Gutiérrez

jose.munoz@isglobal.org

2020-04-07

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

- 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 - Edad ≥ 18 - PCR y serología negativas en día 0 - Trabajador de salud en el Hospital Clinic of Barcelona - Mujeres: Negativas para el test de embarazo - Voluntad de participar en el estudio - Posibilidad de firmar el consentimiento informado

- 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. - Edad <18 - Embarazo o lactancia - Tratamiento antiviral o VIH+ - Tratamiento antiinflamatorio - Tratamiento con cloroquina o hidroxicloroquina - Caso confirmado de SARS-CoV-2 por PCR - Serología positiva para SARS-CoV-2 - Imposibilidad de firmar consentimiento informado - Rechazo a participar en el estudio - Trabajar menos de 5 días a la semana en el Hospital Clinic of Barcelona. - Contraindicaciones hidroxicloroquina: o Hipersensibilidad o Retinopatía o alteraciones visuales o QT largo, bradicardia (<50bpm), taquicardia ventricular, otras arrhythmias o Potasio< 3 mEq/L or AST or ALT > 5 o Antecedente de infarto de miocardio o Myasthenia gravis o Psoriasis o porfiria o Filtrado glomerular < 10ml/min o Historia de hipoglicemia severa o Tratamiento con: antimaláricos, antiarrítmicos, antidepresivos triciclicos, natalizumab, quinolonas, macrolidos, agalsidasa alfa y beta.

2

ISGlobal

18

None

Spain

Health workers

N/A

440

Confirmed cases of a COVID-19 (defined by symptoms compatible with COVID-19 and/or a positive PCR for SARS-CoV-2) in the PrEP group compared to the placebo group at any time during the 6 months of the follow-up in healthcare workers with negative PCR for SARS-CoV-2 at day 0. Casos confirmados de COVID-19 (definidos como sintomatología compatible con COVID-19 y/o PCR positiva por SARS-CoV-2) en el grupo PrEP comparado con el grupo placebo en cualquier momento de los 6 meses de seguimiento en trabajadores sanitarios con PCR negativa en el día 0.

Declared number of arm (3.0) differs from found arms (2.0)

Phase 3

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]