Covid-19 Living Data

Trial NCT04362176
Publication PassITON - Self WH, Chest (2022) (published paper)
Dates: 2020-04-28 to 2021-06-01
Funding: Public/non profit (National Center for Advancing Translational Sciences (NCATS); the Dolly Parton COVID-19 Research Fund.)
Conflict of interest: Yes

Methods
	RCT Blinding: triple blinding
	Location : Multicenter / USA Follow-up duration (days): 28
Inclusion criteria	Adults hospitalized with laboratory-confirmed SARS-CoV-2 infection respiratory symptoms consistent with COVID-19 for fewer than 14 days hospitalized on general medical floors and in intensive care units receiving no oxygen therapy, standard oxygen therapy, high flow oxygen therapy, non-invasive ventilation, or invasive mechanical ventilation.
Exclusion criteria	Prior COVID-19 vaccination use of a COVID-19 passive immunity therapy in the prior 30 days contraindication to blood product transfusion enrollment in other COVID-19 clinical trials
Interventions
	Treatment Convalescent plasma 200-399 mL (1 unit) ABO-compatible convalescent plasma by infusion single dose
	Control Placebo
Participants
	Randomized participants : Placebo=479 Convalescent plasma=495
	Characteristics of participants N= 974 Mean age : NR 550 males Severity : Mild: n=88 / Moderate: n=537 / Severe: n=210 Critical: n=125 Number of vaccinated participants: 0
Primary outcome
	In the register COVID-19 7-point Ordinal Clinical Progression Outcomes Scale [ Time Frame: Study Day 15 ]
	In the report Clinical status (illness severity) 14 days after study infusion measured with a seven-category ordinal scale ranging from discharged from the hospital with resumption of normal activities (lowest score) to death (highest score)
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	Low
General comment	In addition to the published article, the trial registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. The primary and secondary outcomes in the article reflect those in the registry. The trial (n = 974) did not fully achieve its target sample size (n = 1000); recruitment was stopped due to increasing levels of vaccination and likelihood that the trial would not demonstrate efficacy.