NCT04377568.

Trial design: open‐label, phase 2, RCT

Sample size: 100

Setting: inpatient children

Country: Canada

Language: English

Number of centres: 12 

Age 0 to < 19 years old

hospitalised with symptoms compatible with COVID‐19 illness

Laboratory‐confirmed SARS‐CoV‐2 infection as determined by PCR, or other commercial or public health assay in any specimen prior to randomisation

ABO‐compatible CP available

Onset of symptoms began > 12 days before screening

History of adverse reactions to blood products or other contraindication to transfusion

Refusal of plasma for religious or other reasons

Acute heart failure with fluid overload

Any condition or diagnosis, that could in the opinion of the Site Principal Investigator interfere with the participant's ability to comply with study instructions, or put the participant at risk

Anticipated discharge within 24 h

Intervention(s): CP

Details of CP:

• Type of plasma: NR

• Volume: proportional to their weight (10 mL/kg), up to a maximum of 500 mL

• Number of doses: 1

• Antibody‐titre: NR

• Pathogen inactivated: NR

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

Comparator: standard of care

Concomitant therapy: NR

Treatment cross‐overs: no

Primary study outcome: 

• Clinical recovery at day 30

Secondary review outcomes reported

• All‐cause mortality at hospital discharge: NR

• 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

• Admission on the ICU: NR

• Length of stay on the ICU: yes

• Time to discharge from hospital: yes

• QoL: yes

Additional outcomes

• Clinical recovery (time frame: at day 30) defined in the last 24 h as normal respiratory and heart rate (or return to baseline, absence of fever, absence of low blood pressure, oxygen saturation > 94% or room air (or return to baseline), no need for intravenous fluids (or return to baseline)

• Combined mortality/intubation at day 30

• Time to intubation

• Mean number of ventilator‐free days in 30 days

• Mean number of ventilator days in 30 days

• The number of oxygen‐free days in the first 30 days or the incidence and duration of new oxygen use during the trial, defined as oxygen use that was not present at time of randomisation but occurs subsequently

• The proportion of participants needing ECMO in 30 days

• The proportion of participants needing renal replacement therapy

• The proportion of participants developing myocarditis

• Proportion of participants with negative virology (time frame: at day 3, 5, 10 and 15) 

• Modulation of biomarkers (time frame: up to 365 days)

• Resolution of fever (time frame: h)

• Levels of IgG, IgA antibodies and neutralising antibody titres (time frame: at 30 days)

• Efficacy of COVID‐19 CP on respiratory measures using pediatric‐validated dyspnoea (breathlessness) scales

• Evaluate the efficacy of COVID‐19 CP on rehospitalisation after discharge

Recruitment status: 

Prospective completion date: 1 December 2021

Sponsor/funding: The Hospital for Sick Children, C17 Council (regulatory sponsor)