Trial NCT04429854
Publication DAWN-plasma trial - Devos T, Eur Respir J (2021) (published paper)
Dates: 2020-05-02 to 2021-01-26
Funding: Public/non profit (Fonds Wetenschappelijk Onderzoek (FWO) [Research Foundation – Flanders]; Belgian Health Care Knowledge Centre (KCE))
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Belgium
Follow-up duration (days): 30
Inclusion criteria
  • Adult (≥18 years)
  • hospitalised
  • laboratory or radiological confirmed COVID-19
  • Illness of any duration
  • at least one of the following: a) Radiographic infiltrates by imaging (chest X-ray, CT scan or other), or b) Abnormalities on clinical assessment (evidence of rales/crackles on exam) and oxygen saturation (SpO2) ≤ 94% on room air, or c) Requiring supplemental oxygen.
Exclusion criteria
  • Patients receiving mechanical ventilation upon assessment or a therapy restriction code excluding mechanical ventilation and/or endotracheal intubation
  • pregnancy or lactation
  • documented previous grade 3 allergic reaction to plasma transfusions
  • treatment with rituximab or another anti-CD20 monoclonal antibody during the past year
  • Any medical condition which would impose an unacceptable safety hazard by participation to the study, as deemed by the investigator.
Interventions
Treatment
Convalescent plasma
Two units (200-250 mL) intravenously within 12 hours after randomisation, with a second administration of two units 24-36 hours after the first administration (81% from donors with neutralising antibody titres ≥ 1/320; NT50).
Control
Standard care

Participants
Randomized
participants :
Convalescent plasma=326
Standard care=163
Characteristics of participants
N= 489
Mean age : NR
332 males
Severity : Mild: n=57 / Moderate: n=* / Severe: n=* Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Patients requiring mechanical ventilation or death [ Time Frame: No mechanical ventilation at day 15 after hospitalization.] Primary outcome of the study is the number of patients alive without mechanical ventilation at day 15 after hospitalization.
In the report
Number and proportion of patients alive without mechanical ventilation at Day 15.
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:

N
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 In addition to the published article, the protocol, statistical analysis plan and study registry were used in data extraction and risk of bias assessment. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome reflects the reported primary outcome. The study (n=489) achieved the target sample size specified in the paper (n=483).