U1111‐1251‐9286.

Study name	Use of convalescent plasma submitted to pathogen inactivation for the treatment of patients with severe COVID‐19
Methods	Trial design: single‐arm intervention; historic control Sample size: 20 Setting: inpatient Country: Brazil Language: Portuguese Number of centres: 1
Participants	Inclusion criteria  Age ≥ 18 years Severe or critical‐19 COVID‐19 Length of stay < 3 days Laboratory confirmation of COVID‐19 by detection of the viral genome in respiratory secretions, collected by swab Signature, by the patient or a relative, of the informed consent form Exclusion criteria Allergic reactions prior to plasma transfusion Donor eligibility criteria NR Donor exclusion criteria NR
Interventions	Intervention(s): CP therapy Details of CP: Type of plasma: hyperimmune plasma anti‐SARS‐CoV‐2 Volume: NR Number of doses: NR Antibody‐titre: NR Pathogen inactivated: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): NR Comparator: historic control Concomitant therapy: NR Treatment cross‐overs: not applicable
Outcomes	Primary study outcome: Temporal improvement in inflammatory biomarkers and organ dysfunction scores during ICU admission, measured by the daily reduction in 10% of biomarkers in plasma and respiratory secretions, per day for 14 days Primary review outcomes reported All‐cause mortality at hospital discharge: yes Time to death: NR 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: Number of participants with SAEs: NR Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: yes 30‐day and 90‐day mortality: yes Admission on the ICU: yes Length of stay on the ICU: yes Time to discharge from hospital: yes QoL: NR Additional outcomes: NR
Starting date	19 April 2020
Contact information	Pedro Kurtz Address: Rua do Resende 156 City: Ro de Janeiro / Brazil Zip Code: 20231092 Telephone: 2122779352 E‐mail: kurtzpedro@mac.com
Notes	Recruitment status: recruiting Prospective completion date: NR Sponsor/funding: Primary Sponsor: Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti; Secondary Sponsors:  Institution: Paulo Niemeyer State Brain Institute; Source(s) of Monetary or Material Support:  Institution: Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti

AE: adverse event; ALT: alanine transaminase; ARDS: acute respiratory distress syndrome; AST: aspartate transaminase; BAL: bronchoalveolar lavage; BAT: best available therapy; BMI: body mass index; CDC: Centers for Disease Control and Prevention; COI: conflict of interest; COPD: chronic obstructive pulmonary disease; CP: convalescent plasma; CPAP: continuous positive airway pressure; CPK: creatine phosphokinase; CRP: C‐reactive protein; CT: computed tomography; DFPP: double‐filtration plasmapheresis; DVT: deep vein thrombosis; ECMO: extracorporeal membrane oxygenation; ED: emergency department; FDA: US Food and Drug Administration; FiO2: fractional inspired oxygen; GFR: glomerular filtration rate; HBV/HCV: hepatitis B/C; HCPOA: healthcare power of attorney; HLA: human leukocyte antigen; ICU: intensive care unit; IgA (B/G/M): immunoglobulin A (B/G/M); IL‐6: interleukin‐6; IV: intravenous; IVIG: intravenous immunoglobulin; LAR: legal authorised representative; LDH: lactate dehydrogenase; NR: not reported; NYHA: New York Heart Association; PaO2: arterial blood oxygen partial pressure; PCR: polymerase chain reaction; PE: pulmonary embolism; QoL: quality of life; RCT: randomised controlled trial; RNA: ribonucleic acid; RT‐PCR: reverse transcription polymerase chain reaction; SAE: serious adverse event; SARS: severe acute respiratory syndrome; SC: subcutaneous; SOFA: Sequential Organ Failure Assessment; SpO2: peripheral capillary oxygen saturation; TACO: transfusion‐associated circulatory overload; TAD: transfusion‐associated dyspnoea; TB: tuberculosis; TRALI: transfusion‐related acute lung injury; TTP: thrombotic thrombocytopenic purpura; UIP: usual interstitial pneumonia; ULN: upper limit of normal; WBC: white blood count; WHO: World Health Organization