COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001987-28/IT

IRCCS Ospedale San Raffaele

comi.giancarlo@hsr.it

2020-06-24

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

1. Informed consent for participation to the study 2. Age between 18 and 70 years 3. RT-PCR negative for SARS-CoV-2 4. Antibody test for negative SARS-CoV-2 1. Consenso informato per la partecipazione allo studio 2. Età compresa tra i 18 ed i 70 anni 3. RT-PCR negativo per SARS-CoV-2 4. Test anticorpale per SARS-CoV-2 negativo

1. Presence of co-morbidity or concomitant intake of drugs that can interfere with the risk of contracting the infection or influence its course: diabetes, heart failure, neoplastic pathologies, etc.) 2. Immunoactive treatments ongoing 3.State of pregnancy or breastfeeding 4. Contraindications to the use of hydroxychloroquine: History of hypersensitivity or allergy to hydroxychloroquine b.Deficit of glucose-6 phosphate dehydrogenase c.Porfiria d.Psoriasi e.Weight <40 kg f) Previously referred to as retinopathy or visual field disturbances or concomitant intake of drugs known to induce retinopathy (e.g. tamoxifen) g. Previous ventricular cardiac dysrhythmias or proarrhythmic conditions (e.g. bpm <50 / min) h. Concomitant use of digoxin or drugs known to prolong the QT interval (class IA and III antiarrhythmics, tricyclic antidepressants, antipsychotics, halofantrine), insulin or oral hypoglycaemic agents, phenylbutazone, cyclosporine, mefloquine or other antimalarial drugs, anti-septal drugs I. severe chronic renal failure (creatinine clearance <10 ml / min) 5. Hydroxychloroquine treatment at any dose, and for any duration and motivation in the last 6 months 6. Previous diagnosis of COVID-19 or previous symptoms suggestive of disease 1.Presenza di co-morbilità o assunzione concomitante di farmaci che possono interferire col rischio di contrarre l’infezione o influenzarne il decorso: diabete, insufficienza cardiaca, patologie neoplastiche, ecc) 2.Trattamenti immunoattivi in corso 3.Stato di gravidanza e allattamento 4.Controindicazioni all’utilizzo di idrossiclorochina: a.Storia di ipersensibilità o allergia ad idrossiclorochina b.Deficit di glocosio-6 fosfato deidrogenasi c.Porfiria d.Psoriasi e.Peso < 40 kg f.Pregressa riferita retinopatia o disturbi del campo visivo o concomitante assunzione di farmaci noti per indurre retinopatia (es tamoxifene) g.Pregresse disritmie cardiache ventricolari o condizioni proaritmiche (es bpm< 50/min) h.Utilizzo concomitante di digossina o di farmaci noti per prolungare l’intervallo QT (antiaritmici di classe IA e III, antidepressivi triciclici, antipsicotici, alofantrina), insulina o ipoglicemizzanti orali, fenilbutazone, ciclosporina, meflochina o altri antimalarici, farmaci antiepilettici i.Insufficienza renale cronica di grado severo (clearance della creatinina < 10 ml/min) 5.Assunzione di idrossiclorochina per qualsiasi dose, durata e motivazione negli ultimi 6 mesi 6.Pregressa diagnosi di COVID-19 o pregressi sintomi suggestivi di malattia

2

OSPEDALE SAN RAFFAELE

18

100

Italy

Health workers

N/A

1000

• Proportion of hydroxychloroquine treated subjects treated with SARS-CoV-2 positive nasopharyngeal swab compared to controls • Proporzione dei soggetti trattati con idrossiclorochina con tampone nasofaringeo positivo per SARS-CoV-2 rispetto ai controlli

Declared number of arm (2.0) differs from found arms (1.0)

Phase 3

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]