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

NCT04374565.

Study name Efficacy and safety of high‐titer anti‐SARS‐CoV‐2 (COVID19) convalescent plasma for hospitalized patients with infection due to COVID‐19 to decrease complications: a phase II trial
Methods

  • Trial design: single‐arm phase II trial

  • Sample size: 29

  • Setting: inpatient

  • Country: USA

  • Language: English

  • Number of centres: 2 
Participants Inclusion criteria:

  • Patients must be ≥ 18 years

  • Patients hospitalised with COVID‐19 respiratory symptoms within 72 h of admission to a "floor" bed (non‐ICU bed) and confirmation via SARS‐CoV‐2 RT‐PCR testing

  • Patient and/or surrogate is willing and able to provide written informed consent and comply with all protocol requirements.

  • Patients with haematologic malignancies or solid tumours are eligible.

  • Patients with autoimmune disorders are eligible.

  • Patients with immunodeficiency and organ or stem cell transplant recipients are eligible.

  • Patients who have received or are receiving hydroxychloroquine or chloroquine are eligible (but will be taken off the drug).

  • Prior use of IVIG is allowed but the investigator should consider the potential for a hypercoagulable state.


Exclusion criteria:

  • Patients requiring mechanical ventilation or > 6 L/min nasal cannula oxygen

  • Patients on other anti‐COVID‐19 trials being treated with tocilizumab (anti‐IL‐6 receptor), siltuximab (anti‐IL‐2), remdesivir, or other pharmacological trials that may be initiated hereafter.

  • A pre‐existing condition or use of a medication that, in the opinion of the site investigator, may place the individual at a substantially increased risk of thrombosis (e.g. cryoglobulinemia, severe refractory hypertriglyceridemia, or clinically significant monoclonal gammopathy)

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

  • Medical conditions for which receipt of 500‐600 mL of IV fluid may be dangerous to the subject (e.g. decompensated congestive heart failure)
Interventions

  • Intervention(s): high‐titre anti‐SARS‐CoV‐2 (COVID 19) CP

  • Details of CP:

    • Type of plasma: NR

    • Volume: ~200 mL

    • Number of doses: 2 given preferably in 1 day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day

    • Antibody‐titre: high‐titre

    • Pathogen inactivated: NR

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

  • Comparator: historical control group via retrospective chart review

  • Concomitant therapy: NR

  • Treatment cross‐overs: no
Outcomes

  • Primary study outcome:

    • Transfer to ICU (time frame: Days 0‐60)

    • 28 day mortality (time frame: Days 0‐60)

  • Primary review outcomes reported

    • All‐cause mortality at hospital discharge: 28‐day mortality (time frame: Days 0‐60)

    • 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 (cumulative incidence of AEs (AE), grades 3 and 4 AE), Incidence of adverse plasma transfusion reactions: yes (grade 3 or 4 AEs; time frame: days 0‐60) 

    • Number of participants with SAEs: yes (Cumulative incidence of SAEs (time frame: Days 0 ‐ 60)

    • Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days:  yes (ventilator‐free days (time frame: Days))

    • 30‐day and 90‐day mortality: yes (60‐day mortality)

    • Admission on the ICU: yes, (ICU‐free days (time frame: Days 0‐28), transfer to ICU (time frame: Days 0 ‐ 60),

    • Need for ECMO (time frame: Days 0‐60)

    • Length of stay on the ICU: yes (ICU LOS (time frame: days 0‐60)

    • Time to discharge from hospital: yes (hospital length of stay (LOS) (time frame: Days 0‐60))

    • QoL: NR

  • Additional study outcomes

    • Rates and duration of SARS‐CoV‐2 (time frame: Days 0, 7, 14, and 21)

    • Sequential organ failure assessment score (time frame: days 0, 1, 4, 7, 14, 21, 28)

    • Serum of plasma antibody titre to SARS‐CoV‐2 (time frame: Days 0, 7, 14, and 28)

    • Cellular and humoral immune response (time frame: Days 0, 7, 14, 28)

    • Supplemental oxygen‐free days (time frame: Days 0‐28)

    • Ventilator‐free days (time frame: Days 0 ‐ 28)

    • Need for vasopressors (time frame: Days 0 ‐ 60)

    • Need for renal replacement therapy (time frame: Days 0 ‐ 60)
Starting date 5 May 2020
Contact information Kristen M Petros De Guex, MA 434) 924‐5059 KMP6F@hscmail.mcc.virginia.edu
William B Harrington, MPH 434‐409‐5060 wh7fd@hscmail.mcc.virginia.edu
Notes Recruitment status: recruiting
Prospective completion date: 5 April 2021
Sponsor/funding: