Trial RBR-7f4mt9f
Publication De Santis GC, Emerg Infect Dis (2022) (published paper)
Dates: 2020-04-14 to 2020-11-30
Funding: Public/non profit (Fundação de Amparo à Pesquisa do Estado de São Paulo)
Conflict of interest: *

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Brazil
Follow-up duration (days): 60
Inclusion criteria
  • Diagnosis of COVID-19 based on RT-PCR results
  • respiratory distress (oxygen saturation at room air <93%, or arterial partial pressure of oxygen/fraction of inspired oxygen <300, or requiring mechanical ventilation) resulting from pneumonia
  • being within 10 days of initial symptoms
  • age 18–80 years
  • signed written informed consent by the patient or legal representative
Exclusion criteria
  • History of previous severe allergy to plasma transfusion
  • severe congestive heart failure
  • terminal renal failure
  • hepatic cirrhosis
  • any severe illness expected to confer a short life expectancy
  • participation in any other clinical trial with therapeutic intervention
  • immunosuppression
Interventions
Treatment
Convalescent plasma
300 mL by infusion twice a day for 3 days (or 200 mL/400 mL)
Control
Standard care

Participants
Randomized
participants :
Convalescent plasma=37
Standard care=73
Characteristics of participants
N= 110
Mean age : NR
67 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=17 Critical: n=90
Number of vaccinated participants: NR
Primary outcome
In the register
Survival rate in each group on day 30 of orotracheal intubation or diagnosis of respiratory failure
In the report
Death rate at days 30 and 60
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 published paper and retrospective trial registry were used in data extraction and risk of bias assessment. Neither protocol nor statistical analysis plan was available. The 30-day primary outcome in the article reflected that in the registry; the longer primary outcome timepoint of 60 days was not included in the registry. The trial terminated early due to difficulties recruiting as the number of new cases substantially decreased. Consequently, the study (n = 110) did not quite achieve the target sample size planned (n = 120).