Covid-19 Living Data

Trial NCT04539275
Publication VACURES-1 - NCT04539275, Unpublished (2022) (results posted on registry)

Funding: Not reported/unclear
Conflict of interest: *

Methods
	RCT Blinding: triple blinding
	Location : Multicenter / USA Follow-up duration (days): 28
Inclusion criteria	Admitted to a participating VA clinical site with symptoms suggestive of SARS-CoV-2 infection Participant (or legally authorized representative) provides informed consent prior to initiation of any study procedures Participant (or legally authorized representative) understands and agrees to comply with planned study procedures Veteran 18 years of age at time of screening Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or antigen test, as documented by either of the following: (1)Reverse Transcription polymerase chain reaction (RT-PCR) or antigen positive (nasopharyngeal, oropharyngeal, saliva, lower respiratory) in sample collected 72 hours prior to screening or (2)RT-PCR or antigen positive in sample collected > 72 hours but 168 hours (i.e. 7 days) prior to screening, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking > 24 hours, etc.), AND progressive disease suggestive of ongoing SARS-CoV-2 infection Requiring oxygen by nasal cannula or by face-mask as a new treatment (or if previously on home oxygen, at a liter flow at least 2 Lpm greater than home prescription), but not on humidified heated high-flow nasal cannula (HHHFNC) at 15 Lpm Can be randomized within 72 hours of hospital admission. 8.Agrees not to participate in another therapeutic clinical trial for the treatment of COVID-19 or SARS-CoV-2 through Day 29 without approval from the investigator(s). Taking part in other research studies, including those unrelated to SARS-CoV-2, without first discussing it with the investigators of this study may invalidate the results of this study, as well as that of the other study
Exclusion criteria	Respiratory failure requiring mechanical ventilation, non-invasive ventilation including continuous positive airway pressure (CPAP) (for an indication other than previously diagnosed sleep apnea and maintained on outpatient settings), or extra-corporeal membrane oxygenation or anticipated to require any of those treatments or to die within 24 hours Anticipated discharge from the hospital or transfer to another hospital that is not a study site within 72 hours History of previous transfusion reaction Previously documented serum immunoglobulin A (IgA) deficiency (<7 mg/dL) Documented to have received convalescent plasma in the last 60 days
Interventions
	Treatment Convalescent plasma 200-500 mL IV administered in two equally divided doses, less than 12 hours apart
	Control Placebo
Participants
	Randomized participants : Convalescent plasma=35 Placebo=40
	Characteristics of participants N= 75 Mean age : NR 72 males Severity : Mild: n=0 / Moderate: n=74 / Severe: n=1 Critical: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register Proportion of Participants Developing Acute Hypoxemic Respiratory Failure or All-cause Death [ Time Frame: Day 1 through Day 28 ]. Respiratory failure is defined as requiring mechanical ventilation, with or without endotracheal intubations, or extra-corporeal membrane oxygenation.
	In the report NR
Documents available	Protocol Yes. In English 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	The study registry, protocol and statistical analysis plan were used in data extraction and risk of bias assessment. The study (N=75) did not achieve its target sample size (N-702). Early termination of enrollment was recommended by the Data Monitoring Committee.