NCT04524507.

Study name	COVID‐19 antibody plasma research study in hospitalized patients (UNC CCP RCT)
Methods	Trial design: randomised, double‐blinded, phase 2 trial Sample size: 56 Setting: inpatient Country: United States Language: English Number of centres: 1
Participants	Inclusion criteria Age at least 18 years Ability and willingness of participant or Legally Authorised Representative (LAR) to give written informed consent. Laboratory confirmed diagnosis of infection with SARS‐CoV‐2 by PCR Hospitalised for COVID‐19 with one or more respiratory or gastrointestinal (GI) symptoms: COVID‐19 associated respiratory symptoms include but are not limited to: cough, shortness of breath, difficulty breathing, or sore throat COVID‐19 associated GI symptoms include but are not limited to: loss of taste, loss of sense of smell, diarrhoea, nausea, or vomiting Exclusion criteria Receipt of pooled immunoglobulin in past 30 days Current or prior enrolment in a SARS‐CoV‐2 antibody or T‐cell therapeutic study. Contraindication to transfusion or history of prior reactions to transfusion blood products. This may include religious or cultural objections to receiving blood products and transfusions. ABO‐compatible titered plasma is not available > 10 days from noted COVID‐related subjective or objective fever at randomization. Patients without subjective or objective fever, > 10 days from symptom onset as determined by study PI.
Interventions	CP therapy or hyperimmune immunoglobulin therapy: CP  Details of CP: type of plasma: NR volume: NR number of doses: 2‐3 doses antibody‐titre: high‐titre 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): 2‐3 doses of low titre plasma Concomitant therapy: NR Treatment cross‐overs: NR
Outcomes	Primary study outcome:  Cumulative Incidence of serious adverse events (SAEs)at 14 days Primary review outcomes All‐cause mortality at hospital discharge: NR 30‐day mortality: NR 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: yes (day 28) 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: NR 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: yes Additional study outcomes none
Starting date	27 August 2020
Contact information	Corresponding Author Name: JoAnn Kuruc, RN, MSN Affiliation: NR Full Address: NR Email: joann_kuruc@med.unc.edu
Notes	Recruitment status: recruiting Prospective completion date: May 2021 Sponsor/funding: University of North Carolina, Chapel Hill