Trial With or Without Infusion of SARS-CoV-2 Antibody Containing Plasma in High-Risk Patients With COVID-19

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 thepartial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) of lessthan 300 mm Hg.
3. High risk due to either pre-existing or concurrent hematological malignancy and/oractive cancer therapy (incl. chemotherapy, radiotherapy, surgery) within the last 24months or less (group 1) and/or chronic immunosuppression not meeting the criteria ofgroup 1 (group 2) and/or Age ≥ 50 -75 years meeting neither the criteria of group 1nor group 2 (group 3) and at least one of these criteria: Lymphopenia < 0.8 x G/land/or D-dimer > 1μg/mL and/or Age ≥ 75 years meeting neither the criteria of group 1nor 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 thestudy, 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 childbearingpotential: negative urine or serum pregnancy test within 14 days prior to studytreatment.

Exclusion Criteria:

1. Dementia, psychiatric or cognitive illness or recreational drug/alcohol use that inthe opinion of the principle investigator, would affect subject safety and/orcompliance.
2. Contraindication to transfusion or history of prior reactions to transfusion bloodproducts.
3. Patients with selective IgA deficiency.
4. Patients with mechanical ventilation and/or extracoporal membrane oxygenation (ECMO)at time of initial inclusion into the trial. Mechanical ventilation is defined aseither NIV - non-invasive ventilation or positive pressure ventilation. Enrollmentinto another clinical trial evaluating specific therapies for COVID-19 is encouraged.
5. Participation in another trial with an investigational medicinal product.
6. Treatment with SARS-CoV-2 convalescent/vaccine-boosted plasma in the past.