Trial NCT04716556
Publication TSUNAMI - Menichetti F, JAMA (2021) (published paper)
Dates: 2020-07-15 to 2020-12-08
Funding: Public/non profit (Italian National Institute of Health, Istituto Superiore di Sanità (ISS) and the Italian Medicines Agency, Agenzia Italiana del Farmaco (AIFA).)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Italy
Follow-up duration (days): 30
Inclusion criteria
  • Aged at least 18 years
  • confirmed COVID-19 based on a positive reverse transcriptase–polymerase chain reaction (RT-PCR) result for SARS-CoV-2
  • Admitted to the participating clinical sites
  • Radiologically confirmed pneumonia within no more than 10 days from onset of symptoms
  • Partial pressure of oxygen–to–fraction of inspired oxygen (PaO2/FiO2) ratio between 200 and 350mmHg at baseline
  • Written informed consent
Exclusion criteria
  • Pregnant and lactating women
  • Known hypersensitivity to blood products
  • Recipients of immunoglobulin in the past 30 days
  • Conditions precluding infusion of blood products
  • Participants in any other clinical trials
  • Requiring noninvasive or invasive mechanical ventilation
  • Receiving treatment with interleukin (IL) 1, IL 6, or Janus kinase inhibitors at the time of randomization
Interventions
Treatment
Convalescent plasma
200 mL intravenously over 2 hours daily for 1-3 days
Control
Standard care

Participants
Randomized
participants :
Convalescent plasma=241
Standard care=246
Characteristics of participants
N= 487
Mean age : NR
312 males
Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Number of patients who meet invasive mechanical ventilation or death [ Time Frame: at 30 days ] Number of patients who meet invasive mechanical ventilation defined as PaO2/FiO2 <150 or death
In the report
composite of worsening respiratory failure (defined as a PaO2/FiO2 ratio <150mmHg), indicating the potential need for mechanical ventilation, or death.
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

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 prospective protocol and analysis plan along with the supplementary data and the retrospective study registry were used in data extraction and risk of bias assessment. The study (n=487) achieved the target sample size specified in the protocol (n=474). There is no change from the intervention and control treatments outlined in the protocol. The primary outcome reflects the planned reported primary outcomes.