| Study characteristics |
| Methods |
Trial design: case series
Type of publication: journal publication
Setting: ICU
Recruitment dates: 22 February 2020‐29 March 2020
Country: South Korea
Language: English
Number of centres: 1
Trial registration number: NR
Date of trial registration: NR
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| Participants |
Age: 67 and 71
Gender: 1 male, 1 female
Ethnicity: NR
Number of participants (recruited/allocated/evaluated): 2
Severity of disease: critical
Co‐morbidities: case 2 ‐ medical history of hypertension
Inclusion criteria: NR
Exclusion criteria: NR
Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): 400 mg of hydroxychloroquine once daily and lopinavir/ritonavir 400 mg/100 mg twice daily, empirical antibiotics, 4 L/min oxygen flow via nasal cannula, high‐flow oxygen therapy
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| Interventions |
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Details of donors:
Gender: male
HLA and HNA antibody‐negative: NR
Severity of disease: pneumonia
Timing from recovery from disease: 18‐21 days
RT‐PCR tested: yes in 1 participant
Treatment details, including time of plasma therapy (e.g. early stage of disease): administered 7 (case 2) and 22 (case 1) days after admission
Comparator: not applicable
Concomitant therapy: 400 mg of hydroxychloroquine once daily and lopinavir/ritonavir 400 mg/100 mg twice daily, empirical antibiotics, intubation and mechanical ventilator care, IV methylprednisolone (0.5/1 mg/kg/day daily). Unclear whether these treatments were stopped before plasma transfusion or continuously given
Duration of follow‐up: up to 26 days
Treatment cross‐overs: not applicable
Compliance with assigned treatment: good (all compliant)
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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 to the ICU: reported
Length of stay on the ICU: reported
Time to discharge from hospital: reported
QoL: NR
Additional study outcomes: SARS‐CoV‐2 RNA by rRT‐PCR, IL‐6 and CRP, white blood cell count, lymphocyte count, arterial blood gas analysis (PaO2/FiO2), chest X‐ray, overall improvement of clinical symptoms
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| Notes |
Sponsor/funding: funding was provided by: Ministry of Health and Welfare (HI14C1324), Korea HIV/AIDS Cohort Study (2019‐ER5101‐00)
COIs: the authors have no potential conflicts of interest to disclose
Other: "this study was approved by the IRB of Severance Hospital (IRB No. 4‐2020‐0076) and with participants' written informed consent. The images are published under agreement of the patients."
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