NCT04391101.

Study name	Efficacy of convalescent plasma for the treatment of severe SARS‐CoV‐2 infection: a randomized, open label clinical trial
Methods	Trial design: open‐label, RCT Sample size: 231 Setting: ICU Country: Colombia Language: English Number of centres: 8
Participants	Inclusion criteria > 18 years of age SARS‐CoV‐2 infection confirmed by PCR in any sample Hospitalised in the ICU due to shock or respiratory failure, with < 24 h after entering the ICU Exclusion criteria Serious volume overload or other condition that contraindicates plasma transfusion History of anaphylaxis or serious adverse reaction to plasma Previous diagnosis of immunoglobulin A deficiency Donor eligibility criteria > 18 years of age men or nulliparous women with no history of recent abortions or transfusions SARS‐CoV‐2 infection by PCR in any sample or serological test with a maximum of 60 days from resolution of symptoms If donation is done within 14‐28 days after resolution of symptoms, the patient must have a negative PCR test for SARS‐CoV‐2. If donation is done after 28 days of resolving symptoms, no negative control test will be required. Donor exclusion criteria Severe SARS‐CoV‐2 infections with an ICU requirement or those with asymptomatic infections will not be accepted as donors. Nor will a person who has received CP as part of the COVID‐19 treatment
Interventions	Intervention(s): CP therapy Details of CP: Type of plasma: NR Volume: 400‐500 mL total Number of doses: 2 Antibody‐titre: NR Pathogen inactivated: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): ICU patients within 24 h of entering ICU Comparator: standard management Concomitant therapy: NR Treatment cross‐overs: not applicable
Outcomes	Primary study outcome: In‐hospital mortality from any cause (up to 28 days) Primary review outcomes reported All‐cause mortality at hospital discharge: 28‐day mortality 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): yes Number of participants with SAEs: yes 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 (28‐day and 60‐day mortality) Admission on the ICU: no (only ICU patients included) Length of stay on the ICU: NR Time to discharge from hospital: yes (up to 60 days) QoL: NR Additional study outcomes: none
Starting date	June 2020
Contact information	Oliver G Perilla Suarez, Hematologist +573136395608 gerardoperilla@gmail.com         Fabian A Jaimes Barragan, Epidemiologist +5742192420 fabian.jaimes@udea.edu.co
Notes	Recruitment status: not yet recruiting Prospective completion date: December 2021 Sponsor/funding: Hospital San Vicente Fundación, Clínica León XIII, Grupo de Inmunodeficiencias primarias Universidad de Antioquia, Clínica Universitaria Bolivariana, Hospital Pablo Tobón Uribe, Clínica Rosario El Tesoro, Clínica Las Américas, Clínica Cardiovid