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

Jin 2020.

Study characteristics
Methods
  • Trial design: case series

  • Type of publication: preprint

  • Setting: hospital

  • Recruitment dates: 2 February 2020‐27 April 2020

  • Country: China

  • Language: English

  • Number of centres: 1

  • Inclusion/exclusion criteria: NR

  • Trial registration no.: ChiCTR2000033056 

  • Date of trial registration: 19 May 2020

Participants
  • Age: 51‐75

  • Gender: 2 female, 4 male

  • Ethnicity: NR

  • Number of participants (recruited/allocated/evaluated): 6

  • Severity of disease: general, critical and severe critical

  • Co‐morbidities:

    • Patient 1: coronary disease; diabetes mellitus; cerebral infarction

    • Patient 2: cardiac insufficiency; postoperative oesophageal cancer

    • Patient 3: none

    • Patient 4: none

    • Patient 5: hypertension; hyperlipidaemia; diabetes mellitus, cholecystectomy; hysterectomy; tonsillectomy

    • Patient 6: hypertension; coronary heart disease; cerebral haemorrhage; bilateral renal artery stenosis

  • Inclusion criteria: (1) patients with positive laryngeal swab; (2) difficult to turn negative RT‐PCR of COVID‐19 infections and severe disease developed rapidly; (3) recurrent patients (patients whose throat swab became negative and then had a positive result) and worsening symptoms after empirically treated with antivirals. The enrolled patients were not allergic to plasma contents; negative for HBV, HCV, HIV; and not mixed with other bacterial infections. The patients continued to use antivirals while using CP therapy.

  • Exclusion criteria: NR

  • Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): oxygen therapy through nasal catheter, various antivirals, systemic steroids

Interventions
  • Intervention(s): CP therapy

  • Details of CP:

    • Type of plasma: NR

    • Volume: 200 mL once

    • Number of doses: 1

    • Type of antibody test(s) and antibody‐titre(s): serum SARS‐CoV‐2‐specific ELISA antibody titre > 1: 1000 and a neutralising antibody titre > 40

    • Pathogen inactivated: NR

    • RT‐PCR tested: NR

  • Details of donors:

    • Gender: NR

    • HLA and HNA antibody‐negative: NR

    • Severity of disease: NR

    • Timing from recovery from disease: NR

    • RT‐PCR tested: negative for SARS‐CoV‐2 nucleic acid for consecutive two RT‐PCR tests

  • Treatment details, including time of plasma therapy (e.g. early stage of disease): administered between day 22 and day 64 of hospitalisation

  • Comparator: not applicable

  • Concomitant therapy: oxygen therapy through nasal catheter, various antivirals, systemic steroids. Unclear whether these treatments were stopped before plasma transfusion or continuously given.

  • Duration of follow‐up: 49‐64 days

  • Treatment cross‐overs: not applicable

  • Compliance with assigned treatment: good

Outcomes
  • Primary study outcome(s): NR

  • Primary review outcomes

    • All‐cause mortality at hospital discharge: reported (1 patient not discharged at study end)

    • Time to death: not applicable

  • 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): reported

    • Number of participants with SAEs: reported

    • Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: reported

    • 30‐day and 90‐day mortality: not applicable

    • Admission on the ICU: NR

    • Length of stay on the ICU: NR

    • Time to discharge from hospital: reported

    • QoL: NR

  • Additional study outcomes: chest CT, PaO2/FiO2; laboratory data, including lymphocyte count, CRP and IL‐6; changes in complications and the time for the laryngeal swab to change from positive to negative

Notes
  • Sponsor/funding: this study was supported by Science and Technology Support Plan of Guizhou Province in 2019 (Qian Ke He Support [2019] 2834) and Science and Technology Plan of Guizhou Province in 2020 (Qian Ke He Fundamental [2020] 1Z061)

  • COIs: the authors have no potential conflicts of interest to disclose

  • Other: this study was approved by the Biomedical Ethics Committee of Affiliated Hospital of Zunyi Medical University. We have obtained written informed consent from each participant. This study was registered at the Chinese Clinical Trial Register (CCTR number: ChiCTR2000033056, registered 19 May 2020). URL: www.chictr.org.cn/edit.aspx?pid=53859&htm=4