Trial NCT04345991
Publication CORIPLASM - Lacombe K, Vox Sang (2022) (unpublished results)
Dates: 2020-04-16 to 2021-04-21
Funding: Public/non profit (Programme Hospitalier de Recherche Clinique ; Fondation pour la Recherche Médicale ; Sorbonne Université Paris )
Conflict of interest: *

Methods
RCT
Blinding: Unblinded
Location : Multicenter / France
Follow-up duration (days): 28
Inclusion criteria
  • Patients included in the CORIMUNO-19 cohort
  • Onset of COVID19 functional signs <8 days (plasma transfusion may occur up to day 10 of onset)
  • Mild severity as described in the WHO scale
Exclusion criteria
  • Pregnancy
  • Current documented and uncontrolled bacterial infection
  • Prior severe (grade 3) allergic reactions to plasma transfusion
Interventions
Treatment
Convalescent plasma
2 units/day IV for 2 days
Control
Standard care

Participants
Randomized
participants :
Convalescent plasma=60
Standard care=60
Characteristics of participants
N= 120
Mean age : NR
76 males
Severity : Mild: n=0 / Moderate: n=120 / Severe: n=0 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
1. Survival without needs of ventilator utilization or use of immunomodulatory drugs (other than steroids) [ Time Frame: At day 14 after randomization ]; 2. WHO progression scale ≥6 [ Time Frame: at day 4 of randomization ]
In the report
The proportion of patients with WHO CPS greater than 5 on the 10-point scale on day 4 and survival without ventilation or additional immunomodulatory treatment by day 14
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Not reported
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment The conference abstract and trial registry were used in data extraction and risk of bias assessment. The CORIPLASM study is a randomized adaptive trial, nested within the CORIMUNO-19 cohort. The study achieved the target sample size specified in the trial registry (n=120). There is no change from the trial registration in the intervention and control treatments. The registry primary outcome reflects the reported primary outcome. Some outcomes from the registry are not reported in the abstract (e.g., Time from randomization to discharge). Adverse events are not reported. On Oct 5, 2022, this study was updated with information provided by contact with authors. Of note, all time to event outcomes have been adjusted for age and centre.