NCT04497779.

Trial design: observational 

Sample size: 800

Setting: not specified

Country: USA

Language: English

Number of centres: 1

Inclusion criteria:

• Be willing to provide blood samples

• Permit medical record review

• Have documented informed consent

• ≥ 18 years

Exclusion criteria: NR

Details of CP:

• Type of plasma: CP

• Volume: NR

• Number of doses: NR

• Antibody test and antibody‐titre: SARS‐CoV‐2 immunoassay, coronavirus (CoV) PepSeq assay, and SARS‐CoV‐2 lenti‐based neutralising antibody titre

• Pathogen inactivated or not: NR

• RT‐PCR tested: NR

Treatment details, including time of plasma therapy (e.g. early stage of disease): NR

Comparator: nil 

Concomitant therapy: NR

Duration of follow‐up: 12 months 

Treatment cross‐overs: nil

Primary study outcome

• CP units infused in COVID‐19 patients (time frame: up to 12 months after enrolment)

• All‐cause mortality (time frame: at day 28 post‐CP infusion)

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: NR

• Admission on the ICU: NR

• Length of stay on the ICU: NR

• Time to discharge from hospital: reported

• QoL: NR

• Virological response: NR

Additional outcomes: nil 

Recruitment status: recruiting

Prospective completion date: August 21, 2021

Sponsor: City of Hope Medical Center