Trial NCT04397757
Publication PennCCP2 - Bar KJ, J Clin Invest (2021) (published paper)
Dates: 2020-05-18 to 2021-01-08
Funding: Public/non profit (University of Pennsylvania. There was no commercial support for this trial.)
Conflict of interest: Yes

Methods
RCT
Blinding: Unblinded
Location : Multicenter / USA
Follow-up duration (days): 60
Inclusion criteria
  • Hospitalized adults
  • RT-PCR–confirmed SARS-CoV-2 infection
  • radiographic documentation of pneumonia
  • Abnormal respiratory status, defined as room air saturation of oxygen (SaO2) less than 93%, or requiring supplemental oxygen, or tachypnea with a respiratory rate greater than or equal to 30
Exclusion criteria
  • Contraindication to transfusion
  • Participating in other clinical trials of investigational COVID-19 therapy
  • Clinical suspicion that the etiology of acute illness was primarily due to a condition other than COVID-19
  • If ABO-compatible CCP was unavailable.
Interventions
Treatment
Convalescent plasma
Up to 2 units intravenously once-off on day 1
Control
Standard care

Participants
Randomized
participants :
Convalescent plasma=41
Standard care=39
Characteristics of participants
N= 80
Mean age : NR
36 males
Severity : Mild: n=4 / Moderate: n=42 / Severe: n=33 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
1)Participants with serious adverse events. [ Time Frame: Up to 29 days from treatment ]; 2)Cumulative incidence of serious adverse events (SAEs) at Study Day 29. Comparison of clinical severity score between patients on the experimental versus control arms; [ Time Frame: Up to 29 days from treatment ]
In the report
1) Clinical severity score (8-point WHO ordinal score); 2) cumulative incidence of serious adverse events (SAEs) at Day 29
Documents
available

Protocol

NR

Statistical plan

Yes

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 In addition to the published article, the statistical analysis plan, supplementary material, study registry and data from contact with authors were used in data extraction and risk of bias assessment. No protocol was available. There is no change from the trial registration in the intervention and control treatments. Only 1 of the 2 primary outcomes indicated in the registry was reported as a primary outcome in the paper, the other was a secondary outcome. The study (n=80) achieved the target sample size (n=80) specified in the trial registry."
This study was updated on May 9th, 2022 with data obtained from contact with the authors.
This was study was updated on September 14th, 2022 with data extracted from the registry.