NCT04415086.

Study name	Treatment of patients with COVID‐19 with convalescent plasma transfusion: a multicenter, open‐labeled, randomized and controlled study
Methods	Trial design: randomised  Sample size: 120 Setting: hospitalised patients Country: Brazil Language: English Number of centres: 1 Trial registration number: NCT04415086 Date of registration: 4 June 2020
Participants	Inclusion criteria: Age ≥ 18 years Laboratory‐proven COVID‐19 infection by RT‐PCR in any clinical sample Time since symptom onset < 10 days at the time of screening Presence of COVID‐19 pneumonia, with a typical, indeterminate or atypical compatible image in a chest tomography exam (see definition below) Presence of one of the following criteria: Need for > 3L of O2 in the catheter/mask or > 25% in the Venturi mask to maintain O2 saturation > 92% presence of respiratory distress syndrome with PaO2/FiO2 < 300 mmHg If intubated, within 48 h of orotracheal intubation Absence of a history of serious adverse reactions to transfusion, for example, anaphylaxis Participation approval by the research clinician Exclusion criteria:  Already enrolled in another clinical trial evaluating antiviral or immunobiological therapy for the treatment of COVID‐19 IgA deficiency Presence of a clinical condition that does not allow infusion of 400 mL of volume at clinical discretion Pregnancy or breastfeeding Receipt of immunoglobulin in the last 30 days Presence of significant risk of death within the next 48 h at clinical discretion Donor eligibility criteria: NR Donor exclusion criteria: NR
Interventions	Intervention(s): CP therapy (3 arms, randomised 1:1:1 into 3 treatment groups: A‐ standard (control); B‐ standard and CP in a volume of 200 mL (150‐300 mL); C‐ standard and CP in a volume of 400 mL (300‐600 mL)  Details of CP: Type of plasma: CP Volume: 200 mL or 400 mL Number of doses: NR Antibody test and antibody‐titre: NR Pathogen inactivated or not: NR RT‐PCR tested: NR Details of donors:  Gender: NR HLA and HNA antibody: NR Severity of disease: NR Timing from recovery from disease: NR Treatment details, including time of plasma therapy (e.g. early stage of disease):  hospitalised patients Comparator: nil Concomitant therapy: standard of care  Duration of follow‐up: 28 days Treatment cross‐overs: nil
Outcomes	Primary study outcome:  Time elapsed until clinical improvement or hospital discharge  Primary review outcomes reported All‐cause mortality at hospital discharge: reported Time to death: reported Secondary review outcomes reported Number of participants with grade 3 and grade 4 AEs, including potential relationship between intervention and adverse reaction (e.g. TRALI, transfusion‐transmitted infection, TACO, TAD, acute transfusion reactions: reported Number of participants with SAEs: reported Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: reported WHO ordinal scale: reported  30‐day and 90‐day mortality: reported Admission on the ICU: NR Length of stay on the ICU: NR Time to discharge from hospital: reported QoL: NR Virological response:  SARS‐CoV‐2 in nasopharyngeal swab (time frame: Days 0, 1, 3, 7, 14 and 28 after transfusion and control groups) IgG, IgM and IgA titres for SARS‐CoV‐2 (time frame: Days 0, 1, 3, 5, 7, 14 and 28 after transfusion and control groups) Neutralising antibodies (time frame: 0,1,7 14 and 28 days after transfusion and control groups) Additional outcomes: nil
Starting date	1 June 2020
Contact information	Contact: Zelinda B Nakagawa, MsC55‐11‐2661‐7214, zelinda.bartolomei@gmail.com Contact: Natália B Cerqueira55‐112661‐2277, natalia.b.cerqueira@gmail.com
Notes	Recruitment status: recruiting  Prospective completion date: April 20, 2022 Sponsor/funding: University of Sao Paulo General Hospital