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

NCT04264858.

Study name Treatment of acute severe 2019‐nCoV pneumonia with immunoglobulin from cured patients
Methods

  • Trial design: non‐randomised, parallel‐assigned, open trial

  • Sample size: 10

  • Setting: inpatient

  • Country: China

  • Language: English

  • Number of centres: 1
Participants

  • Inclusion criteria

    • Volunteers who have understood and signed the informed consent

    • Age ≥ 18 years, gender unlimited

    • Patients diagnosed with acute severe COVID‐19 pneumonia

      • laboratory (RT‐PCR)‐confirmed infection with COVID‐19

      • lung involvement confirmed with pulmonary CT scan

      • at least 1 of the following conditions should be met: respiratory distress, respiratory rate ≥ 30 times/min; oxygen saturation ≤ 93% in resting state; PaO2/FiO2 ≤ 300 mmHg; respiratory failure and mechanical ventilation are required; shock occurs; ICU monitoring and treatment is required in combination with other organ failure

  • Exclusion criteria

    • Viral pneumonia with other viruses besides COVID‐19

    • Patients are not suitable for immunoglobulin therapy

    • Participation in other studies

    • Other circumstances in which the investigator determined that the patient is not suitable for the clinical trial
Interventions

  • CP therapy or hyperimmune immunoglobulin therapy: immunoglobulin of cured patients

  • Details of CP:

    • type of plasma: immunoglobulin

    • volume: 0.2 g/kg

    • number of doses: daily for 3 doses

    • antibody‐titre: NA

    • 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): gamma globulin 0.2 g/kg

  • Concomitant therapy: NR

  • Treatment cross‐overs: NR
Outcomes

  • Primary study outcome: time to clinical improvement, defined as the time (in days) from initiation of study treatment (active or placebo) until a decline of 2 categories from admission status on a six‐category ordinal scale of clinical status which ranges from 1 (discharged) to 6 (death) (for categories ordinal scale, see Additional outcomes).

  • Primary review outcomes

    • All‐cause mortality at hospital discharge: yes (up to day 28)

    • Time to death: NR

  • Secondary review outcomes

    • 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: NR

    • 30‐day and 90‐day mortality: NR

    • Admission on the ICU: NR

    • Length of stay on the ICU: NR

    • Time to discharge from hospital: NR

    • QoL: NR

  • Additional outcomes

    • Time to clinical improvement using 6 category ordinal scale (time frame: up to 28 days)

      • 6. Death;

      • 5. ICU, requiring ECMO and/or IMV;

      • 4. ICU/hospitalization, requiring NIV/ HFNC therapy;

      • 3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC);

      • 2. Hospitalization, not requiring supplemental oxygen;

      • 1. Hospital discharge.

    • Clinical status assessed by the ordinal scale (on days 7, 14, 21, and 28)

    • The differences in oxygen intake methods (time frame: up to 28 days)

      • no need for supplemental oxygenation

      • nasal catheter oxygen inhalation

      • mask oxygen inhalation

      • noninvasive ventilator oxygen supply

      • invasive ventilator oxygen supply

    • Duration (days) of supplemental oxygenation (time frame: up to 28 days)

    • Duration (days) of mechanical ventilation (time frame: up to 28 days)

    • Mean PaO2/FiO2 (time frame: up to 28 days)

    • Lesions of the pulmonary segment numbers involved in pulmonary CT (every 7 days) (time frame: up to 28 days)

    • Time to COVID‐19 RT‐PCR negativity in respiratory tract specimens (every 3 days) (time frame: up to 28 days)

    • Dynamic changes of COVID‐19 antibody titre in blood (time frame: up to 28 days)

    • Length of hospital stay (days) (time frame: up to 28 days)
Starting date 17 March 2020
Contact information Xiang Cheng
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Notes

  • Recruitment status: recruiting

  • Prospective completion date: 31 May 2020

  • Sponsor/funding: Wuhan Union Hospital, China