A Randomized Open label Phase-II Clinical Trial with or without Infusion of Plasma from Subjects after Convalescence of SARS-CoV-2 Infection in High-Risk Patients with Confirmed Severe SARS-CoV-2 Disease - RECOVER

Ruprecht-Karls-Universität Heidelberg, Medical Faculty, University Hospital Heidelberg -0 个研究点目标入组 174 人开始时间: 2020年4月20日最近更新: 2022年4月25日

适应症

试验速览

暂无简介。

•1. PCR confirmed SARS-CoV-2 infection in a respiratory tract sample.
•2. Oxygen saturation (SaO2) of 94 % or less while breathing ambient air or a ratio of the
•partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) of less than 300 mm Hg.
•3. High risk due to either pre-existing or concurrent hematological malignancy and/or active cancer therapy (incl. chemotherapy, radiotherapy, surgery) within the last 24 months or less (group 1)
•chronic immunosuppression not meeting the criteria of group 1 (group 2)
•Age = 50 - 75 years meeting neither the criteria of group 1 nor group 2 (group 3)
•and at least one of these criteria: Lymphopenia < 0.8 x G/l
•D-dimer > 1µg/mL
•Age = 75 years meeting neither the criteria of group 1 nor group 2 (group 4).
•4. Blood hemoglobin concentration = 8 g/dl.
•5. Provision of written informed consent.
•6. Patient is able to understand and comply with the protocol for the duration of the study, including treatment and scheduled visits and examinations.
•7. Male or female patient aged = 18 years.
•8. Postmenopausal or evidence of non-childbearing status. For women of childbearing potential: negative urine or serum pregnancy test within 14 days prior to study treatment.
•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 87
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 87

•1. Dementia, psychiatric or cognitive illness or recreational drug/alcohol use that in the
•opinion of the principle investigator, would affect subject safety and/or compliance.
•2. Contraindication to transfusion or history of prior reactions to transfusion blood
•3. Patients with known selective IgA deficiency.
•4. Patients with mechanical ventilation and/or extracoporal membrane oxygenation
•(ECMO) at time of initial inclusion into the trial.
•5. Participation in another trial with an investigational medicinal product.
•6. Treatment with SARS-CoV-2 convalescent plasma in the past.

发起方

Ruprecht-Karls-Universität Heidelberg, Medical Faculty, University Hospital Heidelberg -