Coronavirus disease 2019 (COVID-19) / SARS-CoV-2 Disease MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations MedDRA version: 23.1 Level: PT Classification code 10084460 Term: COVID-19 treatment System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 23.0 Level: LLT Classification code 10084270 Term: SARS-CoV-2 acute respiratory disease System Organ Class: 10021881 - Infections and infestat
Conditions
Interventions
Product Name: RECOVER CT SARS-CoV-2-ab Plasma COVID-19 (HD)
Product Code: CP/PVP COVID19
Pharmaceutical Form: Infusion
Sponsors
Ruprecht-Karls-Universität Heidelberg, Medical Faculty, University Hospital Heidelberg -
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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) and/or chronic immunosuppression not meeting the criteria of group 1 (group 2) and/or Age = 50 - 75 years meeting neither the criteria of group 1 nor group 2 (group 3) and at least one of these criteria: Lymphopenia 1µg/mL and/or 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
Exclusion criteria
Exclusion criteria: 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 products. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the time from randomization until an improvement within 84 days defined as two points on a seven point ordinal scale or live discharge from the hospital in high-risk patients (group 1 to group 4) with SARS-CoV-2 infection requiring hospital admission by infusion of plasma from subjects after convalescence of SARS-CoV-2 infection or standard of care. ;Secondary Objective: 1. To assess overall survival, and the overall survival rate at 28, 56 and 84 days. 2. To assess SARS-CoV-2 viral clearance and load, cytokine changes over time as well as antiviral antibody titers. 3. To assess percentage of patients that required mechanical ventilation. 4. To assess time from randomization until discharge.;Primary end point(s): Time to clinical improvement (within 84 days) by two points on a seven point ordinal scale or live discharge from the hospital.;Timepoint(s) of evaluation of this end point: Treatment response is assessed daily until day 28, thereafter weekly until day 56 and finally at day 84. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall survival, defined as the time from randomization until death from any cause. - 28-day, 56-day and 84-day overall survival rates. - SARS-CoV-2 viral clearance and load as well as antibody titers. - Requirement mechanical ventilation at any time during hospital stay (yes/no). - Time until discharge from randomization, taking death as competing risk into account. - Viral load, changes in antibody titers and cytokine profiles are analyzed in an exploratory manner using paired non-parametric tests (before – after treatment).;Timepoint(s) of evaluation of this end point: Continuously. | — |
Countries
Germany
Contacts
Public ContactProf. Dr. Carsten Müller-Tidow
University Hospital Heidelberg; Dpt. of Internal Medicine V Hematology, Oncology and Rheumatology
Outcome results
None listed