| Study characteristics |
| Methods |
Trial design: RCT
Type of publication: journal publication
Setting: hospital
Recruitment dates: 14 February 2020‐1 April 2020
Country: China
Language: English
Number of centres: 7
Trial registration number: ChiCTR2000029757
Date of registration: NR
|
| Participants |
Age: median 70 years, IQR 62‐78 years
Gender: 60 male (58.3%), 43 female (41.7%)
Ethnicity: NR
Number of participants (recruited/allocated/evaluated): 103 (52 CP, 51 standard treatment)
Severity of disease: severe or life‐threatening
Co‐morbidities: hypertension, cardiovascular disease, cerebrovascular disease, diabetes, liver disease, cancer, kidney disease
-
Inclusion criteria:
signed informed consent
aged at least 18 years
COVID‐19 diagnosis based on PCR testing
positive PCR result within 72 h prior to randomisation
pneumonia confirmed by chest imaging
clinical symptoms meeting the definitions of severe or life‐threatening COVID‐19
acceptance of random group assignment
hospital admission
willingness to participate in all necessary research studies and be able to complete the study follow‐up
no participation in other clinical trials, such as antiviral trials, during the study period
-
Exclusion criteria:
pregnancy or lactation
immunoglobulin allergy
IgA deficiency
pre‐existing comorbidity that could increase the risk of thrombosis
life expectancy < 24 h
disseminated intravascular coagulation
severe septic shock
PaO2/FIO2 of < 100
severe congestive heart failure
detection of high titre of S protein–RBD‐specific IgG antibody (≥ 1:640)
other contraindications as determined by the patient’s physicians
participation in any antiviral clinical trials for COVID‐19 within 30 days prior to enrolment
Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): antivirals, antibiotics, steroids, human Ig, Chinese herbal medicines, interferon
|
| Interventions |
CP therapy or hyperimmune immunoglobulin therapy: CP therapy
-
Details of CP:
Type of plasma: plasmapheresis
Volume: 4‐13 mL/kg of recipient body weight, median 200 mL, IQR 200‐300 mL
Number of doses: 1 (96%) or more
Antibody test and antibody‐titre: only the plasma units with an S‐RBD–specific IgG titre of at least 1:640 were used correlating to serum neutralisation titre of 1:80
Pathogen inactivated or not: NR
RT‐PCR tested: NR
-
Details of donors:
Gender: both, 18‐55 years suitable for blood donation
HLA and HNA antibody‐negative: NR
Severity of disease: NR
Timing from recovery from disease: discharged from hospital > 2 weeks
RT‐PCR tested: lab‐confirmed COVID‐19 diagnosis, 2 negative PCR results from nasopharyngeal swabs at least 24 h apart prior to hospital discharge
Treatment details, including time of plasma therapy (e.g. early stage of disease): severe to life‐threatening
For studies including a control group: comparator (type): standard therapy
Concomitant therapy: antivirals, antibiotics, steroids, human Ig, Chinese herbal medicines, interferon
Duration of follow‐up: 28 days
Treatment cross‐overs: none
Compliance with assigned treatment: 1 participant in control arm received CP, 1 participant in CP arm discontinued study
|
| Outcomes |
Primary study outcome(s): clinical improvement within 28 days (patient discharged alive or reduction of 2 points on a 6‐point disease severity scale)
-
Primary review outcomes
-
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: reported
Admission on the ICU: NR
Length of stay on the ICU: NR
Time to discharge from hospital: reported
QoL: NR
Additional study outcomes: rate of viral PCR to negative at up to 72 h
|
| Notes |
Sponsor/funding: this work was supported by the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences (CIFMS) grants 2020‐I2M‐CoV19‐006, 2016‐I2M‐3‐024 (Dr Z. Liu), and 2017‐I2M‐1‐009 (Dr L. Li) and the Nonprofit Central Research Institute Fund of Chinese Academy of Medical Sciences grant 2018PT32016 (Dr Z. Liu)
COIs: Dr Liu reports holding a pending patent on COVID‐19 testing. Dr Wu reports consulting for Verax Medical and Grifols, receiving royalties from UptoDate and AABB, and being a volunteer visiting professor and receiving travel support for giving medical education from the Chinese Institute of Blood Transfusion. No other disclosures were reported.
Other: nil
|