Covid-19 Living Data

Trial NCT04621123
Publication Alemany A, Lancet Respir Med (2022) (published paper)
Dates: 2020-11-10 to 2021-07-28
Funding: Mixed (The Fight AIDS and Infectious Diseases Foundation (Badalona, Spain) with funding from the pharmaceutical company, Grifols Worldwide Operations (Dublin, Ireland); the Crowdfunding campaign, YoMeCorono; the Hospital Universitari Germans Trias i Pujol, and Banc de Sang i Teixits de Catalunya.)
Conflict of interest: No

Methods
	RCT Blinding: double blinding
	Location : Multicenter / Spain Follow-up duration (days): 60
Inclusion criteria	50 years or older non-hospitalised (not admitted to hospital) with mild-to-moderate COVID-19 confirmed SARS-CoV-2 infection, with a positive PCR or validated antigen rapid test result received no more than 5 days before randomization symptom onset no more than 7 days before randomization Mild and moderate COVID-19 were defined according to international guidelines: patients with fever, cough, sore throat, malaise, headache, and muscle pain were considered to have mild COVID-19, whereas evidence of lower respiratory disease by clinical assessment or imaging and a saturation of oxygen 94% or more on room air was considered moderate COVID-19.
Exclusion criteria	Severe COVID-19 required hospitalisation for any cause history of a previous SARS-CoV-2 infection received one or two doses of a COVID-19 vaccine contraindications to the investigational product increased thrombotic risk history of clinically significantly abnormal liver function (eg, Child-Pugh C) or chronic kidney disease stage 4 or worse pregnant, breastfeeding, or planning a pregnancy during the study period.
Interventions
	Treatment Convalescent plasma 250–300 mL intravenously once-off
	Control Placebo
Participants
	Randomized participants : Convalescent plasma=188 Placebo=188
	Characteristics of participants N= 376 Mean age : NR 203 males Severity : Mild: n= 366/ Asymptomatic: n=0 Number of vaccinated participants: 0
Primary outcome
	In the register Hospitalization rate (safety and efficacy) [ Time Frame: Day 28 ]; SARS-CoV-2 viral load (safety and efficacy) [ Time Frame: Day 7 ]
	In the report Incidence of hospitalisation within 28 days from baseline; change in viral load in nasopharyngeal swabs from baseline to day 7.
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 prospective trial registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. There is no change from the trial registration in the intervention and control treatments. The primary outcomes reported in the article reflect those in the registry. Recruitment to the trial was terminated on the advice of the data and safety monitoring board because more than 85% of the target population had been vaccinated (an exclusion criterion) and thus the study (n= 376) did not achieve the target sample size (n=474). This study was updated on May 11th, 2022 with data acquired from contact with authors.