Covid-19 Living Data

Trial NCT04415086
Publication COOP-COVID-19-MCTI - Song ATW, Lancet Reg Health Am (2022) (published paper)
Dates: 2020-06-02 to 2020-11-18
Funding: Public/non profit (Brazilian Ministry of Science, Technology and Innovation, Fundação de Amparo à Pesquisa do Estado de São Paulo.)
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / Brazil Follow-up duration (days): 28
Inclusion criteria	Aged 18 years or older RT-PCR-confirmed COVID-19 infection in any clinical sample less than 10 days after onset of symptoms at screening presence of COVID-19 pneumonia with a typical, indeterminate, or atypical compatible chest computerized tomography scan and at least one of the following criteria - need for >3 L of O2 in catheter/mask or >25% in the Venturi mask to maintain O2 saturation >92% or presence of respiratory distress syndrome with PaO2/FiO2 <300 mmHg intubated patients were considered eligible within 48 h of orotracheal intubation.
Exclusion criteria	History of serious adverse reactions to transfusion participation in another COVID-19 treatment clinical trial using antiviral or immunobiological drugs IgA deficiency presence of a clinical condition that precluded infusion of 400 ml of plasma at clinical discretion pregnant or breastfeeding a history of receiving immunoglobulin in the past 30 days a significant risk of death within the next 48 h at clinical discretion.
Interventions
	Treatment Convalescent plasma 400 400 mL (range 300−600 mL) once-off administered within 24 h after randomization and could be split in two stages within 24 h. The plasma infusion lasted up to 1 h. Convalescent plasma 200 200 mL (range 150−300 mL) once-off administered within 24 h after randomization. The plasma infusion lasted up to 1 h.
	Control Standard care
Participants
	Randomized participants : Convalescent plasma 400 =44 Convalescent plasma 200 =43 Standard care=42
	Characteristics of participants N= 129 Mean age : NR 88 males Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=* Number of vaccinated participants: 0
Primary outcome
	In the register Time elapsed until clinical improvement or hospital discharge [ Time Frame: Follow up until 28 days after transfusion ] clinical improvement is defined as the time from the randomization date until the decline of 2 categories on the ordinal scale of 10 categories or hospital discharge (whichever comes first).
	In the report Time to clinical improvement at day 28, defined as the number of days from randomization to the first decline of at least two categories on the World Health Organization's ordinal progression scale or hospital discharge, whichever came first
Documents available	Protocol NR 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 trial registry and statistical analysis plan/protocol were used in data extraction and assessment of risk of bias. Supplementary appendices referred to in the article were not available through the journal website as stated. The primary outcome in the article reflects that in the registry. The trial (n = 129) achieved its target sample size (n = 120).