Covid-19 Living Data

Trial NCT04803370
Publication Bargay-Lleonart J, J Clin Med (2022) (published paper)

Funding: Public/non profit (Health Research Institute of the Balearic Islands)
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / Spain Follow-up duration (days): 21
Inclusion criteria	Age greater than or equal to 18 years male or female hospitalized in a COVID-19 area (non-intensive care where COVID-19 patients were hospitalized for specific management SARS-CoV-2 on nasopharyngeal swabs at the time of the screening presence of respiratory symptoms and/or fever associated with COVID-19, with clinical time evolution equal to or less than 7 days (day 1 being the day of symptom onset, and including day 7) presence of pneumonia on chest X-ray and/or SatO2 < 94% aa Sequential Organ Failure Assessment score (SOFA) < 6 ability to understand the patient information sheet and sign written informed consent accepting the condition of complying with the procedures established in the protocol.
Exclusion criteria	Patients with a previous history of allergic reaction to any blood component pregnant or lactating women patients treated with plasma within 21 days prior to the screening patients with incompatible conditions, e.g., being a participant in other clinical trials.
Interventions
	Treatment Convalescent plasma Two doses of 300 mL intravenously every 24 h on days 1 and 2
	Control Standard care
Participants
	Randomized participants : Convalescent plasma=38 Standard care=17
	Characteristics of participants N= 55 Mean age : NR 33 males Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register WHO clinical progression scale [Time Frame: Day 21]. The scale provides a measure of illness severity across a range from 0 (not infected) to 9 (Mechanical ventilation pO2/FiO2 <150 and vasopressors, dialysis, or ECMO)
	In the report Time to recover or achieve clinical improvement, where recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: (1) Not hospitalized, no limitations on activities (Point = 8); (2) not hospitalized, limitation on activities, and/or requiring home oxygen (Point = 7); (3) hospitalized, not requiring supplemental oxygen—no longer requires ongoing medical care (Point = 6)
Documents available	Protocol NR Statistical plan NR 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 study registry was used in data extraction and risk of bias assessment. The protocol and statistical analysis plan were not available. "The trial was terminated early due to the impossibility of recruitment due to the pandemic". The target sample size was therefore not achieved.