NCT04432272.

Trial design: controlled trial, non‐randomised with 2 arms, both receiving CP 

Sample size: 500

Setting: hospitalised patients 

Country: USA

Language: English

Number of centres: 8

Trial registration number: NCT04432272

Date of registration: 16 June 2020

Inclusion criteria:

• Participants must be ≥ 18 years

• Hospitalised with confirmed COVID‐19 infection via COVID‐19 SARS‐CoV‐2 RT‐PCR testing

• Symptoms consistent with COVID‐19 infection (fever, acute onset cough, shortness of breath) at time of screening

• Patient requires > 6 L nasal cannula oxygen (Group A) or intubated (Group B)

• Patient (or their LAR) is willing and able to provide written informed consent and comply with all protocol requirements

Exclusion criteria:

• For participants in Group A admitted for > 14 days

• Female participants with positive pregnancy test, breastfeeding, or planning to become pregnant or breastfeed during the study period

• Receipt of pooled immunoglobulin in past 30 days

• Contraindication to transfusion or history of prior reactions to transfusion blood products

• Patients currently undergoing cancer treatment or those who are presently immunocompromised

• Patient who in the opinion of the investigator will not be a good study candidate

Donor eligibility criteria: NR

Donor exclusion criteria: NR

Intervention(s): CP therapy 

• Participants will be assigned to a study group depending on how sick they are

• Group A: those who require > 6 L of supplemental oxygen but are not on a ventilator

• Group B: those who require a ventilator to preserve their life

Details of CP:

• Type of plasma: CP

• Volume: 200 mL

• Number of doses: 1

• Antibody test and antibody‐titre: NR

• Pathogen inactivated or not: NR

• RT‐PCR tested: NR

Details of donors: 

• Gender: NR

• HLA and HNA antibody: NR

• Severity of disease: variable 

• Timing from recovery from disease: variable 

  • donors either: 1) been symptom‐free for 14 days and screen negative via nasopharyngeal swab or 2) symptom‐free for at least 28 days or 3) individuals who have never had symptoms of COVID‐19 but were found to have elevated anti‐SARS‐CoV‐2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA

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

Comparator: nil

Concomitant therapy: standard of care 

Duration of follow‐up: 28 days

Treatment cross‐overs: nil

Primary study outcome: 

• Avoidance of intubation at 28 days (group A) (time frame: 28 days)

• Mortality (group B) (time frame: 28 days)

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: 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: reported

• WHO ordinal scale: reported 

• 30‐day and 90‐day mortality: reported 

• Admission on the ICU: reported

• Length of stay on the ICU: reported

• Time to discharge from hospital: reported

• QoL: NR

• Virological response: reported (count of participants with presence of SARS‐CoV‐2 RNA detected by RT‐PCR‐tested nasopharyngeal swabs

Additional outcomes: renal failure, liver failure, presence of ARDS, ventilator‐free days 

Recruitment status: not yet recruiting

Prospective completion date: August 2021

Sponsor/funding: William Beaumont Hospitals