Study sites and trial eligibility
cancer, hematological cancer
CANCER, VIRUS, DISEASES, SELECTIVE IMMUNOGLOBULIN A DEFICIENCY
Fifteen trial sites in Germany enrolled study participants (ten university hospitals and five urban hospitals; Supplementary Tables Group 1 (cancer): patients with pre-existing or concurrent hematological cancer and/or receiving active cancer therapy for any cancer (including chemotherapy, radiotherapy and surgical treatments) within the past 24 monthsGroup 2 (immunosuppression): patients experiencing chronic immunosuppression, either pharmacological or due to underlying diseases not meeting group 1 criteriaGroup 3 (lymphopenia/elevated Group 4 (age >75 years): patients aged >75 years and not meeting group 1, 2 or 3 criteriaInclusion criteria were consecutively checked for groups 1–4 in ascending order.Patients with a history of reaction to blood products, patients requiring mechanical ventilation (including noninvasive ventilation), patients with selective immunoglobulin A deficiency and patients participating in another trial of investigational medicinal products were excluded. Further details on inclusion/exclusion are provided in the published protocolEligible patients underwent randomization into the experimental (plasma) or control arm at a 1:1 ratio using block randomization for the patient group strata defined above (groups 1–4). Patients randomized into the control arm were offered to crossover on day 10 (plus a maximum of 2 d) after randomization in the absence of clinical improvement. Control arm patients received the standard of care as defined by the respective hospital at the time of trial inclusion. Patients in the plasma arm received two units of ABO-compatible plasma (238–337 ml each from two different donors) on the day of randomization (day 1) and on a later day. This was administered intravenously in addition to the standard of care. Convalescent and/or vaccinated donor plasma was obtained at the IKTZ Heidelberg. Plasma donor eligibility required high titers of neutralizing antibody activity in a live virus neutralization assay (titers ≥ 1:80; <20% of potential donors) (see the information on plasma donation and the neutralization assay used for determination of titers in donors in the 