Convalescent Plasma for COVID-19 | NCT04365439 | Trialant

Convalescent Plasma for COVID-19 | NCT04365439 | Trialant

Arms/Interventions Module

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Titers of anti-SARS-CoV-2 antibodies in the plasma derived from convalescent donors		At plasma donation
Change in titers of anti-SARS-CoV-2 antibodies in patients' plasma		Change from baseline at day 21
Change in inflammatory cytokines concentration (e.g. IL-6, HMGB1)		Change from baseline at day 7
Viral load decay in the recipient after plasma transfusion with semiquantitative assessment of nasopharyngeal swabs	Semiquantitative measure of viral load by rtPCR for SARS-CoV-2 by nasopharyngeal swabs, at diagnosis and on day 1,3,7	Change from day of diagnosis at day 1

Secondary Outcomes

Measure	Description	Time Frame
Number of patients with improvement in the 7-points Ordinal Scale	7-point ordinal scale measure on day 0 (Baseline), day 1, 3 and 7 after plasma transfusion	At day 7
Proportion of patients with adverse events, severity of adverse events

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32219428	Background	Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.