| Study characteristics |
| Methods |
Trial design: case report
Type of publication: open‐access article
Setting: inpatient/ICU
Recruitment period: NR
Country: China
Language: English
Number of centres: 1
Trial registration number: NR (case report)
Date of trial registration: NR
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| Participants |
Age: 64 years
Gender: female
Ethnicity: NR
Number of participants (recruited/allocated/evaluated): 1
Severity of disease: severe
Comorbidities: hypertension, diabetes
Inclusion criteria: NR
Exclusion criteria: NR
Additional diagnoses: NR
Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): mechanical ventilation
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| Interventions |
CP therapy or hyperimmune immunoglobulin therapy: CP
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Details of CP:
Type of plasma: IgM reactive plasma; free of hepatitis B and C virus, HIV, syphilis, and residual SARS‐CoV‐2
Volume: 200 mL
Number of doses: unclear
Type of antibody test and antibody‐titre: IgG titrated by semiquantitative ELISA: 1:1: 6.59; 1:10: 5.33; 1:20: 4.87; 1:40: 3.87; 1:80: 3.24; 1:160: 2.20; 1:320: 2.17/> 1:160
Pathogen inactivated or not: NR
RT‐PCR tested: NR
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Details of donors:
Gender: 4 male, 2 female,
HLA and HNA antibody‐negative: NR
Severity of disease: laboratory‐confirmed SARS‐CoV‐2 infection
Timing from recovery from disease: NR
RT‐PCR tested: recovery certificated by 2 consecutively negative SARS‐CoV‐2 PCR assay
Treatment details, including time of plasma therapy (e.g. early stage of disease): 1 week after admission to ICU
For studies including a control group: comparator (type): not applicable
Concomitant therapy: NR
Duration of follow‐up: 11 days after transfusion; then transferred to general ward
Treatment cross‐overs: none
Compliance with assigned treatment: good (compliant), transferred to general ward
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| Outcomes |
Primary study outcome: antibody levels in CP
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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): none
Number of participants with SAEs: none
Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: reported for day 11
30‐day and 90‐day mortality: NR (all alive)
Admission on the ICU: reported
Length of stay on the ICU: reported
Time to discharge from hospital: remains on general ward
Additional study outcomes: lymphocyte count, renal and liver function, prothrombin time, CPK, LDH and myocardial enzymes
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| Notes |
Sponsor/funding: "this study was supported by Medical Science and Technology Development Foundation, Nanjing Department of Health (ZKX18050). Dr. Xiang Xue is supported by the National Institutes of Health (K01DK114390) and a Research Scholar Grant from the American Cancer Society (RSG‐18‐050‐01‐NEC)."
COIs: declared to have no conflicts of interest
Other: case series focusing on CP donors
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