NCT04649879.

Trial design: open‐label randomised controlled trial (2:1)

Sample size: 920

Setting: inpatient

Country: Sweden

Language: English

Number of centres: 3

Inclusion criteria

• Age greater than or equal to 18

• Admitted to a study hospital

• Active COVID‐19 defined as symptoms + SARS‐CoV‐2 identified from upper or lower airway samples and blood

• Negative pregnancy test taken before inclusion and use of an acceptable effective method of contraception until treatment discontinuation if the participant is a woman of childbearing potential

• Written informed consent after meeting with a study physician and ability and willingness to complete follow up

Exclusion criteria

• No matching plasma donor (Exact matching in the ABO system is required)

• Unavailability of plasma

• Estimated glomerular filtration rate < 30 (kidney failure stage III or more)

• Pregnancy (urinary‐hcg)

• Breast feeding

• Inability to give informed consent

CP therapy or hyperimmune immunoglobulin therapy: CP 

Details of CP:

• type of plasma: convalescent plasma

• volume: 200 ml over 2 hours

• number of doses: daily infusion until SARS‐CoV‐2 is no longer detectable in the blood up to a maximum of 10 CP infusions

• antibody‐titre: NR

• 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): standard of care for COVID‐19 patients

Concomitant therapy: If steroid therapy has not already been initiated, betamethasone 3 mg daily will be given concomitantly with steroid therapy or longer if clinically indicated but for a maximum of 10 days.

Treatment cross‐overs: none

Primary study outcome: 

• COVID‐19 related mortality within 28 days

Primary review outcomes

• All‐cause mortality at hospital discharge: NR

• 30‐day mortality: reported

Secondary review outcomes

• Clinical status, assessed by need for respiratory support with standardised scales (e.g. WHO Clinical Progression Scale, WHO Ordinal Scale for Clinical Improvement at up to 7 days, 8 to 15 days, 16 to 30 days: NR

• Mortality (time to event): NR

• 90‐day mortality: NR

• Time to discharge from hospital: NR

• Admission to the intensive care unit (ICU): NR

• Length of stay on the ICU: NR

• Viral clearance, assessed with RT‐PCR test at baseline, up to 3, 7, and 15 days: probably reported

• QoL: NR

• Number of participants with grade 3 and grade 4 adverse events, including potential relationship between intervention and adverse reaction (e.g. transfusion‐related acute lung injury (TRALI), transfusion‐transmitted infection, transfusion‐associated circulatory overload (TACO), transfusion‐associated dyspnoea (TAD), acute transfusion reactions): NR

• Number of participants with serious adverse events: NR

• Number of participants with serious adverse events: reported 

Additional study outcomes

• COVID‐19 related mortality within 60 days

• Requirement of invasive ventilation or Pao₂/FiO₂ ≤ 70 for ≥ 12 hours in the case of patients not eligible for intensive care

• Adverse events

• Dose of plasma needed to clear viraemia 

• Time to clearance of viraemia

Recruitment status: Not yet recruiting

Prospective completion date:  1 February 2022

Sponsor/funding: Joakim Dillner