| 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
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| 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
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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
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| Interventions |
Intervention(s): CP therapy
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Details of CP:
-
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
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| Outcomes |
Primary study outcome(s): NR
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Primary review outcomes
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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
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| 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
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