Trial ISRCTN85216856
Publication Baldeon ME, Transfus Med (2022) (published paper)
Dates: 2020-05-10 to 2020-10-31
Funding: Public/non profit (Salvar Vidas Ecuador (SalvarVidasEC))
Conflict of interest: No

Methods
RCT
Blinding: triple blinding
Location : Multicenter / Ecuador
Follow-up duration (days): 28
Inclusion criteria
  • Signed informed consent
  • ≥18 years of age
  • both sexes
  • COVID-19 diagnosis based on: any molecular testing-polymerase chain reaction (RT-PCR), clinical diagnosis or lung imaging tests
  • patients with impairment of previously normal lung function defined with a SaO2 <90% at 0.5FiO2 and/or with an increased O2 need in the previous 24 h upon admission
  • patients with a score of 5–6 on the New Early Warning Scale for COVID-19 patients.
Exclusion criteria
  • Pregnant or lactating
  • had diagnosis of cancer, HIV infection, superimposed systemic infections, liver failure, renal failure, chronic obstructive pulmonary disease, pulmonary fibrosis, and restrictive pulmonary pathologies
  • had been receiving immunosuppressants for a different condition than SARS-CoV-2 infection
  • were participating in any other clinical trial
  • patients with history of previous blood/derivate transfusion
Interventions
Treatment
Convalescent plasma
5 ml/kg intravenously once-off
Control
Placebo

Participants
Randomized
participants :
Convalescent plasma=63
Placebo=95
Characteristics of participants
N= 158
Mean age : NR
107 males
Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=*
Number of vaccinated participants: NR
Primary outcome
In the register
Case fatality rate assessed through data collected from the follow-up instrument and medical record at 21 and 28 days
In the report
Survival rate before 28 days since onset of plasma transfusion treatment.
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Yes
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 study registry was used in data extraction and risk of bias assessment. The protocol and statistical analysis plan were not available. There is no change from the trial registration in the intervention and control treatments. The primary outcome in the article reflected that in the registry. The study (n=158) did not achieve its target sample size (n=200) as it was suspended early due to futility after a planned interim analysis."