RECOVER: A Randomized Open-label Phase-II Trial with or without Infusion of Convalescent Plasma in High-Risk Patients with Severe COVID-19 Disease

clinical trial - Convalescent plasma (CP) has been hypothesized to improve outcome in COVID-19 patients. Randomized trials are urgently needed for high-risk patients especially prior to full blown ARDS and mechanical ventilation. This multicenter phase II trial will analyze the effects of CP in high-risk patients with COVID-19 infection. Patients at high risk for a poor outcome due to underlying disease (group 1, pre-existing or concurrent hematological malignancy and/or ongoing chemotherapy for cancer; group 2, chronic immunosuppression not meeting criteria group 1; group 3, age 50-75 years and lymphopenia <0>1µg/mL not meeting criteria groups 1 or 2; group 4, age = 75 years not meeting criteria for either 1, 2 or 3) are eligible for enrollment. Eligibility also requires PCR confirmed SARS-CoV-2 infection and O2 saturation =93% while breathing ambient air. Patients are randomized to receive (experimental arm) or not receive (standard arm) convalescent plasma from two different donors (day1, day2). A cross-over from the standard arm into the experimental arm is possible after day 10 in case of not improving or worsening clinical condition. The primary endpoint is the time to clinical improvement defined as two points improvement on a seven-point ordinal scale of patient state of health or discharge alive from the hospital. Secondary outcomes are mortality, changes in clinical scores, inflammatory cytokine changes and viral load dynamics. This trial systematically assesses the therapeutic role of convalescent plasma for treating SARS-CoV-2 infection in a high-risk patient population.