Home treatment of elderly patients with symptomatic SARS-CoV-2 infection (COVID-19) : a multiarm, multi-stage (MAMS) randomized trial to assess the efficacy and safetyof several experimental treatments to reduce the risk of hospitalization or death(COVERAGE trial) - COVERAGE

CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX, ETABLISSEMENT PUBLIC0 个研究点目标入组 845 人开始时间: 2020年4月1日最近更新: 2022年1月17日

适应症

试验速览

暂无简介。

•? Positive SARS-CoV-2 test on nasopharyngeal swab
•? Onset of symptoms < 5 days prior to nasopharyngeal swabbing
•? Age = 60 years old
•? Valid, ambulatory person, fully capable of understanding the challenges of the trial
•? No hospitalization criteria according to current recommendations
•? Signed informed consent
•? Covered by Health Insurance
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1057

•?Inability to make a decision to participate (dementia, guardianship)
•?Long QT syndrome, or QTc space > 500 ms
•?Heart rate <50 / min
•?Hyperkalemia > 5.5 mmol/L or hypokalemia < 3.5 mmol/L
•?Treatment with dasatinib, nilotinib, ibrutinib, , potent inhibitors of cytochrome P450 CYP3A4 isoenzyme, potent inducers of cytochrome P450 CYP3A4 isoenzyme, repaglinide, azathioprine, 6-mercaptopurine, theophylline, pyrazinamide, warfarin.
•?Hypersensitivity to any of the trial drugs, , ARA2 or sartan.
•?Liver failure (stage = Child-Pugh B), stage 4 or 5 chronic kidney disease (DFG <30 mL/min/1.73 m²), person on dialysis, malabsorption syndrome, symptomatic gout/hyperuricemia, ileus, colitis or enterocolitis, chronic infection with the hepatitis B virus.

发起方

CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX, ETABLISSEMENT PUBLIC