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
Blinding: double blinding
Multicenter / Spain |
Follow-up duration (days): 60
250–300 mL intravenously once-off
|Characteristics of participants|
Mean age : NR
Severity : Mild: n= 366/ Asymptomatic: n=0
Number of vaccinated participants: 0
|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.
Yes. In English
Data-sharing willing stated in the publication:
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
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.