Covid-19 Living Data

Trial NCT04383535
Publication PlasmAr - Simonovich VA, N Engl J Med (2020) (published paper)
Dates: 2020-05-28 to 2020-08-27
Funding: Mixed (Self-supported by participant institutions; Research Council of Hospital Italiano de Buenos Aires; National Council of Scientific Research and Technology (CONICET) Institute, National Ministry of Science, Technology, a)
Conflict of interest: *

Methods
	RCT Blinding: double blinding
	Location : Multicenter / Argentina Follow-up duration (days): 30
Inclusion criteria	Hospitalized adults (at least 18 years of age) reverse-transcriptase–polymerase-chain-reaction (RT-PCR) assay of a respiratory tract sample that was positive for SARS-CoV-2, radiologically confirmed pneumonia, no previous directives rejecting advanced life support, and at least one of the following severity criteria: oxygen saturation (SaO2) below 93% while they were at rest and breathing ambient air, a ratio of the partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) below 300 mm Hg (PaO2:FiO2), or a Sequential Organ Failure Assessment (SOFA) or modified SOFA (mSOFA) score of two or more points above baseline status (scores range from 0 to 24, with higher scores indicating more severe disease).
Exclusion criteria	Patients who were pregnant or lactating, patients of reproductive age who were not willing to use contraceptive measures for a period of 30 days after enrollment, and patients with a history of blood component allergies, an infectious cause of pneumonia other than SARS-CoV-2, a requirement for mechanical ventilation, multiorgan failure, or any other condition that would impede the provision of informed consent.
Interventions
	Treatment Convalescent plasma 5-10 mL/kg (Inferior limit = 400 mL - Superior limit = 600 mL) IV infusion once off at a rate of 5-10 mL/kg/h.
	Control Placebo
Participants
	Randomized participants : Convalescent plasma=228 Placebo=106
	Characteristics of participants N= 334 Mean age : NR 225 males Severity : Mild: n=0 / Moderate: n=0 / Severe: n=333 Critical: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register Clinical status during follow-up at 30th day [ Time Frame: 30th Day since study preparation infusion ]
	In the report Clinical status 30 days after intervention, as represented by one of six mutually exclusive ordinal categories on an adapted version of the World Health Organization (WHO) clinical scale
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	In addition to the published article, the trial registry, study protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. There were no substantive differences between the published article, the trial registry, study protocol, statistical analysis plan in study procedures, population, treatments or outcomes. The study achieved its planned sample size. Some outcomes from the registry and protocol are not reported in the paper (e.g. percentage of patients with negative SARS-CoV-3 PCR at day 14) This study was updated on February 2nd, 2021 after contact with authors.