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. 2020 Jul 10;2020(7):CD013600. doi: 10.1002/14651858.CD013600.pub2

NCT04373460.

Study name Comparison of the efficacy and safety of human coronavirus immune plasma (HCIP) vs. control (SARS‐CoV‐2 non‐immune) plasma among outpatients with symptomatic COVID‐19
Methods

  • Trial design: phase 2, double‐blind, RCT

  • Sample size: 1344

  • Setting: inpatient

  • Country: USA

  • Language: English

  • Number of centres: 1
Participants Inclusion criteria:

  • ≥ 18 years of age

  • Competent and capable to provide informed consent

  • Positive RNA test for presence of SARS‐CoV‐2 in fluid collected by oropharyngeal or nasopharyngeal swab

  • Experiencing any symptoms of COVID‐19 including but not limited to fever (T> 100.5º F), cough, or other COVID‐associated symptoms like anosmia

  • ≤ 8 days since the first symptoms of COVID‐19

  • ≤ 8 days since first positive SARS‐CoV‐2 RNA test

  • Able and willing to comply with protocol requirements listed in the informed consent


Exclusion criteria:

  • Hospitalised or expected to be hospitalised within 24 h of enrolment

  • Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect participant safety and/or compliance

  • History of prior reactions to transfusion blood products

  • Inability to complete therapy with the study product within 24 h after enrolment

  • Receiving any treatment drug for COVID‐19 within 14 days prior to screening evaluation (off‐label like hydroxychloroquine, compassionate use or study trial related)
Interventions

  • Intervention(s): SARS‐CoV‐2 CP

  • Details of CP:

    • Type of plasma: plasma obtained from volunteers who have recovered from SARS‐Cov‐2 infection

    • Volume: ~200‐250 mL 

    • Number of doses: 1

    • Antibody‐titre: titre ≥ 1:320 or current FDA standard titre

    • Pathogen inactivated: NR

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

  • Comparator: standard control plasma

  • Concomitant therapy: NR

  • Treatment cross‐overs: no
Outcomes

  • Primary study outcome:

    • Cumulative incidence of hospitalisation or death prior to hospitalisation (time frame: Up to day 28)

    • Cumulative incidence of treatment‐related SAEs (time frame: Up to day 28)

    • Cumulative incidence of treatment‐related grade 3 or higher AEs (time frame: Up to day 90 

  • Primary review outcomes reported

    • All‐cause mortality at hospital discharge: Cumulative incidence of hospitalisation or death prior to hospitalisation (time frame: Up to day 28)

    • 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 (Incidence of adverse plasma transfusion reactions: Cumulative incidence of treatment‐related SAEs (time frame: Up to day 28), Cumulative incidence of treatment‐related grade 3 or higher AEs (time frame: Up to day 90)

    • 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: invasive mechanical ventilation during infection;  ECMO duration during infection: NR

    • 30‐day and 90‐day mortality: NR

    • Admission on the ICU: yes, (time to ICU admission, invasive mechanical ventilation or death in hospital (time frame: up to day 90)

    • Length of stay on the ICU: NR

    • Time to discharge from hospital: NR

    • QoL: NR

  • Additional study outcomes

    • Change in serum SARS‐CoV‐2 antibody titres (time frame: Days 0, 14, 28 and 90)

    • Time to SARS‐CoV‐2 PCR‐negativity (time frame: up to day 28)

    • Change in level of SARS‐CoV‐2 RNA (time frame: Day 0‐Day 28)

    • Change in oxygen saturation levels (time frame: Day 0‐Day 28)

    • Rate of participant‐reported secondary infection of housemates (time frame: up to day 90)

    • Time to resolution of COVID‐19 symptoms (time frame: up to day 90)

    • Impact of CP on outcome as assessed by change in hospitalisation rate (time frame: Day 0‐Day 90)

    • Impact of donor antibody titres on hospitalisation rate of CP recipients (time frame: Day 0‐Day 90)

    • Impact of donor antibody titres on antibody levels of CP recipients (time frame: Day 0‐Day 90)

    • Impact of donor antibody titres on viral positivity rates of CP recipients (time frame: Day 0‐Day 90)
Starting date 19 May 2020
Contact information David J Sullivan, MD 410‐502‐2522 dsulliv7@jhmi.edu, David Sullivan, MD 410‐502‐2522 dsulliv7@jhmi.edu
Notes Recruitment status: not yet recruiting
Prospective completion date: 21 December 2022
 Sponsor/funding: Johns Hopkins University, State of Maryland, Bloomberg Foundation, Principal Investigator: David J Sullivan, MD The Johns Hopkins University