Hydroxychloroquine sulfate early administration in symptomatic out of hospital COVID-19 positive patients. Hydro-Stop-COVID19 Trial - Hydro-STOP-COVID19 Trial

ASUR (Azienda Sanitaria Unica Regionale) Marche0 个研究点目标入组 216 人开始时间: 2020年6月26日最近更新: 2021年1月5日

适应症

试验速览

暂无简介。

•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.
•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 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•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.

发起方

ASUR (Azienda Sanitaria Unica Regionale) Marche