Efficacy of Hydroxychloroquine, Telmisartan and Azithromycin on Survival in Elderly Hospitalized Patients with VIDOC-19 : A Randomized, Multi-Centre, Adaptive, Blinded Study - COVID-Aging

Hôpitaux Universitaires de Strasbourg0 个研究点目标入组 1,600 人开始时间: 2020年3月29日最近更新: 2022年3月14日

试验速览

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•- Subject Male or female age = 75, or = 60 if dementia
•- Subject infected with COVID 19 (confirmed by RT-PCR SARS-CoV-2 detectable less than 5 days old and clinical picture)
•- Clinical manifestation of COVID 19 requiring hospitalization
•- Subject affiliated to a social health insurance scheme
•- Subject capable of understanding the objectives and risks of the research and of giving dated and signed informed consent, or agreement given by a trusted person, guardian or trustee.
•- Subject who has been informed of the results of the prior medical examination
•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 500
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1100

•Patients with a negative RT-PCR SARS-CoV-2 result
•- Patients with COVID19 pneumopathy requiring resuscitative breathing support
•- Patient on Sartan (Telmisartan, Candesartan, Valsartan, etc...), another antihypertensive, Hydroxychloroquine or Chloroquine, or macrolides (Azithromycin, Clarythromycyin...) within the last 24 hours.
•- Patient with a contraindication to one of the treatments proposed in the study
•- Contraindication Hydroxychloroquine: citalopram, escitalopram, hydroxyzine, domperidone, piperaquine, QT prolongation (>470ms for men and >480 ms for women), retinopathy, hypersensitivity to the active substances or to one of the excipients.
•- Contraindication Azithromycin: combination with ergot derivatives, combination with colchicine, patients at risk of developing cardiac arrhythmia (diagnosis of QT interval prolongation (>470ms for men and >480 ms for women), severe hepatic impairment, history of allergy to macrolides or any of the excipients used in this study.
•- Contraindication Telmisartan: Combination with drugs containing aliskiren, severe hepatic impairment, biliary obstruction, hypersensitivity to the active substance or to any of the excipients used in this study.
•- Subject under safeguard of justice

发起方

Hôpitaux Universitaires de Strasbourg