| Study characteristics |
| Methods |
Trial design: case series
Type of publication: novel report in Chest journal
Setting: hospitals in China
Recruitment period: 30 January‐17 March 2020
Country: China
Language: English
Number of centres: 4
Trial registration number: NR (case series)
Date of trial registration: NR
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| Participants |
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Age: 31‐73 years
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Gender: 2 male, 2 female
Ethnicity: not stated
Number of participants (recruited/allocated/evaluated): 4
Severity of disease: critical
Comorbidities: hypertension (participants 1 and 3), COPD (participant 2), chronic kidney impairment (participant 3), pregnancy (participant 4)
Inclusion criteria: NR
Exclusion criteria: NR
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Additional diagnoses:
participant 1: bacterial pneumonia, fungal pneumonia, pneumorrhagia, ARDS, septic shock
participant 2: ARDS
participant 3: ARDS, renal failure, fungal pneumonia, multiple organ failure, septic shock, pneumorrhagia, cystorrhagia, GI bleeding, pneumothorax
participant 4: ARDS, septic shock, multiple organ failure, cardiac failure, newborn death due to asphyxia, bacterial infection
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Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation)
participant 1: antiviral therapy (arbidol, lopinavir‐ritonavir, interferon alpha), antibacterial therapy, antifungal therapy, supportive care, IVIG, albumin, zadaxin, mechanical ventilation
participant 2: antiviral therapy (arbidol, lopinavir‐ritonavir, interferon alpha 2a), noninvasive mechanical ventilation/high‐flow nasal cannula, corticosteroids (methylprednisolone)
participant 3: antiviral therapy (arbidol, lopinavir‐ritonavir, interferon alpha 2b, oseltamivir, ribavirin), mechanical ventilation, renal replacement therapy, antifungal therapy (caspofungin, voriconazole), venovenous ECMO
participant 4: antiviral therapy (lopinavir‐ritonavir, ribavirin), mechanical ventilation, renal replacement therapy, antibacterial therapy (imipenem, vancomycin), caesarean section, venovenous ECMO
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| Interventions |
CP therapy or hyperimmune immunoglobulin therapy: CP
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Details of CP:
Type of plasma: prepared from recovered patients, no other information provided
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Volume: 200‐2400 mL
participant 1: 900 mL
participant 2: 200 mL
participant 3: 2400 mL
participant 4: 300 mL
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Number of doses: 1‐8 doses
participant 1: 3 doses (200 mL, 400 mL, 300 mL each)
participant 2: 1 dose
participant 3: 8 doses (each dose not stated)
participant 4: 1 dose
Antibody test and antibody‐titre: NR
Pathogen inactivated or not: NR
RT‐PCR tested: NR
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Details of donors:
Treatment details, including time of plasma therapy (e.g. early stage of disease): days 11‐41 admission
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participant 1: days 19, 29, 30 admission
participant 2: day 11 admission
participant 3: day 15, 23, 27, 30, 32, 34, 38, 41 admission
participant 4: day 19 admission
For studies including a control group: comparator (type): none (not applicable)
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Concomitant therapy:
participant 1: antiviral therapy (arbidol, lopinavir‐ritonavir, interferon alpha), antibacterial therapy, antifungal therapy, supportive care, IVIG, albumin, zadaxin, mechanical ventilation
participant 2: antiviral therapy (arbidol, lopinavir‐ritonavir, interferon alpha 2a), noninvasive mechanical ventilation/high‐flow nasal cannula, corticosteroids (methylprednisolone)
participant 3: antiviral therapy (arbidol, lopinavir‐ritonavir, interferon alpha 2b, oseltamivir, ribavirin), mechanical ventilation, renal replacement therapy, antifungal therapy (caspofungin, voriconazole), venovenous ECMO
participant 4: antiviral therapy (lopinavir‐ritonavir, ribavirin), mechanical ventilation, renal replacement therapy, antibacterial therapy (imipenem, vancomycin), caesarean section, venovenous ECMO
Duration of follow‐up: up to 51 days
Treatment cross‐overs: none
Compliance with assigned treatment: good (all compliant)
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| Outcomes |
Primary study outcome: 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): 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: yes (extubation date reported), 15 days post‐first plasma infusion (participant 1) and 22 days post‐first plasma infusion (participant 4), participant 2 already off respiratory support prior to plasma infusion, participant 3 remained in ICU up to the time of report writing
30‐day and 90‐day mortality: NR (all alive)
Admission on the ICU: all in ICU at baseline
Length of stay on the ICU: NR
Time to discharge from hospital: 3 participants, 1 remained in ICU up to the time of report writing
QoL‐ NR
Additional study outcomes: viral load, antibody (ELISA), chest imaging results
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| Notes |
Sponsor/funding: NR
COIs: none disclosed
Other: NR
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