COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001558-23/IT

ASUR MARCHE - UOC Cardiologia ASUR AV5

hcq.stop.covid19.trial@gmail.com

2020-06-26

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Patients with SARS-CoV-2 infection in a nasopharyngeal sample, with diagnosis, carried out in a centralized core-lab. 2. Patients confined at home because their clinical picture was judged by the local Health authorities not severe enough to require hospitalization. 3. Patients agree to maintain seclusion at home up to viral negativization of the nasopharyngeal test in two consecutive samples, according to Italian laws. 4. Patients with 1 or more of the following symptoms/signs on the day of nasopharyngeal sample: 1) Fever (>37.0° Celsius), 2) Cough. 1. Pazienti con infezione da SARS-CoV-2 (diagnosi effettuata in un laboratorio centrale centralizzato con modalità definite) > 18 aa ed in isolamento domiciliare obbligato 2. Che dopo informativa hanno firmato il consenso 3. in isolamento domiciliare per quadro clinico lieve caratterizzato dalla presenza si 1 o più dei seguenti sintomi / segni nel giorno del campione nasofaringeo positivo: Febbre (> 37,0 ° Celsius), Tosse.

1. Age <18 years. 2. Allergy to HCQ or chloroquine. 3. Contraindication to treatment with the study drug for one or more of the following conditions: retinopathy, G6PD deficiency, Long-QT syndrome or treatment with drugs associated with QTc prolongation (unless these drugs can be safely discontinued during HCQ treatment). Appendix 1 shows a table, derived from AIFA, which lists these drugs. 4. Breastfeeding and pregnant patients will be excluded based on their declaration and pregnancy test results when required. 1. Allergia a HCQ o clorochina. 2. Controindicazione al trattamento con il farmaco in studio per una o più delle seguenti condizioni: retinopatia, deficit di G6PD, sindrome del QT lungo o trattamento con farmaci associati al prolungamento del QTc (a meno che questi farmaci non possano essere interrotti in modo sicuro durante il trattamento con HCQ). (viene fornito elenco) 3. L'allattamento e gravidanza (definita in base ad auto dichiarazione e ai risultati dei test di gravidanza quando richiesto).

2

ASUR (Azienda Sanitaria Unica Regionale) Marche

18

100

Italy

Mild disease at enrollment

1: Mild disease at enrollment

216

virological clearance (nasopharyngeal sample negative for SARS-CoV-2 virus) at the sample taken on days 8. Co-primary end-point: Hospital admission over the time-interval between day 0 (randomization) and day 15. clearance virologica (campione rinofaringeo negativo per il virus SARS-CoV-2) al campione prelevato nei giorni 7-9. (viene fatto anche un2° test al giorno 14-17)

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"}]