Reconvalescent plasma/Camostat mesylate early in Sars-CoV-2 Q-PCR positive high risk individuals - RES-Q HR

Heinrich-Heine-University Düsseldorf0 个研究点目标入组 497 人开始时间: 2020年10月15日最近更新: 2021年12月21日

适应症

试验速览

暂无简介。

•1.Individuals (female, male diverse) = 18 years with SARS-CoV-2 infection, confirmed by PCR before study enrollment
•2.SARS-CoV-2 positive PCR = 3 days old (date of NP swab)
•3.Ability to provide written informed consent
•4.Potassium values between 3.5-4.9 mmol/l
•5.Platelets on full blood count must be = 50.000/µl
•6.Presence of at least one of the following criteria:
•- Patients = 55 years
•- BMI = 35 kg/m2,
•- coronary artery disease (CAD),
•- chronic kidney disease (CKD) with GFR <60 ml/min but = 30 ml/min,
•- diabetes mellitus,
•- active tumor disease
•-Patients with chronic pulmonary disease, e.g. obstructive pulmonary disease (COPD), pulmonary fibrosis
•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 398
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 95

•1.Age <18 years
•2.Unable to give informed consent
•3.Pregnant women or breast-feeding mothers
•4.Known hypersensitivity to camostat mesylate and/or severe pancreatitis
•5.Life expectancy < 6 months
•6.Duration SARS-CoV-2 typical symptoms > 3 days
•7.SARS-CoV-2 PCR detection older than 3 days
•8.SARS-CoV-2 associated clinical condition = WHO stage 3 (patients hospitalized for other reasons than mAB treatment, pAB-treatment, CP-treatment,
•social reasons and COVID-19 may be included if they fulfill all inclusion and none of the exclusion criteria)
•9.Previously or currently hospitalized due to SARS-CoV-2
•10.Previous antiviral therapy for SARS-CoV-2
•11.ALT or AST > 5 x ULN at screening
•12.Liver cirrhosis > Child A (patients with Child B/C cirrhosis are excluded from the trial)
•13.Chronic kidney disease with GFR < 30 ml/min
•14.Concurrent or planned anticancer treatment during trial period
•15.Accommodation in an institution due to legal orders (§40(4) AMG).
•16.Any psycho-social condition hampering compliance with the study protocol.
•17.Evidence of current drug or alcohol abuse.
•18.Use of other investigational treatment within 5 half-lives of enrollment is prohibited
•19.Concomitant proven influenza A infection
•20.Patients with organ or bone marrow transplant in the three months prior to Screening Visit

发起方

Heinrich-Heine-University Düsseldorf