. 2021 May 20;2021(5):CD013600. doi: 10.1002/14651858.CD013600.pub4

NCT04333251.

Study name	Evaluating convalescent plasma to decrease coronavirus associated complications. A phase I study comparing the efficacy and safety of high‐titer anti‐SARS‐CoV‐2 plasma versus best supportive care in hospitalized patients with interstitial pneumonia due to COVID‐19
Methods	Trial design: open‐label, phase I, parallel‐RCT Sample size: 115 Setting: hospital Country: USA Language: English Number of centres: 1
Participants	Inclusion criteria ≥ 18 years Must have been hospitalised with COVID‐19 respiratory symptoms within 3‐7 days from the beginning of illness Patient and/or LAR willing to provide informed consent Patient agrees to storage of specimens for future testing Exclusion criteria ≤ 18 years Receipt of pooled immunoglobulin in past 30 days Contraindication to transfusion or history or prior reactions to transfusion blood products Women who are identified as donors must not be pregnant Donor eligibility criteria ≥ 18 years Must have been hospitalised with COVID‐19 respiratory symptoms and confirmation via COVID‐19 SARS‐CoV‐2 RT‐PCR testing but are now PCR‐negative by 2 nasopharyngeal testing Women of child‐bearing potential must have a negative serum pregnancy test Donor and/or LAR willing to provide informed consent Donor agrees to storage of specimens for future testing
Interventions	CP therapy or hyperimmune immunoglobulin therapy: CP therapy Details of CP: type of plasma: NR volume: NR number of doses: 1‐2 units antibody‐titre > 1:64 pathogen inactivated or not: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): NR For studies including a control group: comparator (type): best supportive care Concomitant therapy: oxygen therapy Treatment cross‐overs: not applicable
Outcomes	Primary study outcome: reduction in oxygen and ventilation support (time frame: through study completion, an average of 4 weeks) Primary review outcomes All‐cause mortality at hospital discharge: NR Time to death: NR Secondary review outcomes 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): NR 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: NR Admission on the ICU: NR Length of stay on the ICU: NR Time to discharge from hospital: NR QoL: NR Additional outcomes: NR
Starting date	1 April 2020
Contact information	NR
Notes	Recruitment status: not yet recruiting Prospective completion date: 31 December 2022 Sponsor/funding: NR