Study characteristics |
Methods |
Trial design: case series
Type of publication: preprint
Setting and dates: inpatient
Recruitment period: 31 January 2020‐22 March 2020
Country: China
Language: English
Number of centres: 1
Trial registration number: NR
Date of trial registration: NR
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Participants |
Age: 28‐75 years (participants 1‐6: 69, 75, 56, 63, 28, 57)
Gender: 3 male, 3 female (participants 1‐6: M, F, M, F, F, M)
Ethnicity: NR
Number of participants (recruited/allocated/evaluated): 6
Severity of disease: critical (note: participant 5 was not critically ill), late course of disease, laboratory values mostly normal
Comorbidities: bronchitis and Sjogren's in participants 3 and 4, none in other participants
Inclusion criteria: (1) laboratory‐confirmed cases; (2) patients with abnormalities in chest CT (participant 5 was an exception); (3) patients with deteriorated symptoms after standard treatment; (4) patients with persistent positive result of throat swab; (5) critically ill patients
Exclusion criteria: (1) patients allergic to plasma contents; (2) patients positive for HBV, HCV and HIV; (3) patients with uncontrolled bacterial mixed infection; (4) patients with malignant tumours; (5) patients who developed MODS
Additional diagnoses: none
Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): oxygen therapy (nasal) in 4 participants, antiviral therapy (arbidol in all participants), antibiotics (levofloxacin in 1 participant)
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Interventions |
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Treatment details, including time of plasma therapy (e.g. early stage of disease): critically ill participants in later stages of infection
admission to study centre on 7 February, first transfusion on 10 March, repeated transfusions on 13 and 16 March
admission to study centre on 12 February, first transfusion on 5 March, repeated transfusion on 9 March
admission to study centre on 12 February, first transfusion on 5 March, repeated transfusion on 6 and 9 March
admission to study centre on 11 February, first transfusion on 10 March
admission to study centre on 5 March, first transfusion on 13 March
admission to study centre on 12 March, first transfusion on 18 March
For studies including a control group: comparator (type): none
Concomitant therapy: oxygen therapy, antiviral therapy (arbidol in all participants), antibiotics (levofloxacin in 1 participant)
Duration of follow‐up: up to discharge (5 participants; 1 further monitored after negative swab tests (follow‐up unclear))
Treatment cross‐overs: none
Compliance with assigned treatment: good (all compliant)
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Outcomes |
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Primary study outcome:
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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, none occurred (3‐day follow‐up)
Number of participants with SAEs: reported, none occurred (3‐day follow‐up)
Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: specific time of recovery NR
30‐day and 90‐day mortality: reported (all alive and time point not reached)
Admission on the ICU: none admitted to ICU
Length of stay on the ICU: reported, none admitted to ICU
Time to discharge from hospital: reported in 5 participants, range 10‐34 days, 1 further monitored after negative swab tests (follow‐up unclear)
QoL: NR
Additional study outcomes: Blood and swab samples were obtained to measure serum anti‐SARS‐CoV‐2 IgM and IgG titres and throat SARS‐CoV‐2 nucleic acid, respectively
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Notes |
Sponsor/funding: "this study was partially sponsored by grants National Natural Science Foundation of China (#81802301 to Mingxiang Ye, #81772500 to Tangfeng Lv), and Jiangsu Provincial Key Research and Development Program (BE2018713 to Xinyi Xia)."
COIs: study authors declare no competing interests
Other: "this study was reviewed and approved by the Medical Ethical Committee of Wuhan Huoshenshan Hospital. Written informed consent was obtained from each participant. The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding authors had full access to all the data in the study and had final responsibility for the decision to submit for publication."
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