6/29/23, 11:42 PM SIREN-C3PO Pathway Feedback Search Clinical Topics Home Studies SIREN C3PO SIREN C3PO Disease COVID 19 infection Trial question What is the role of early convalescent plasma in high-risk outpatients with COVID-19? Study design Multi-center Single blinded RCT Population Characteristics of study participants 54.0% female N = 511 46.0% male 511 patients (274 female, 237 male) Inclusion criteria: patients who were being treated in an emergency department for COVID-19 symptoms Key exclusion criteria: receipt of another investigational treatment for COVID-19; patients ineligible to receive up to 250 ml of fluid; prior adverse reaction from blood product transfusion; receipt of any blood product within the past 120 days Interventions N=257 convalescent plasma (1 unit of convalescent plasma with a high titer of antibodies against SARS-CoV-2) N=254 placebo (1 unit of saline with multivitamin) https://web.pathway.md/studies/recXSYYyWmQUskP17 1/2 6/29/23, 11:42 PM SIREN-C3PO Pathway Primary outcome Rate of disease progression within 15 days 31.9 % 31.9 30 23.9 % 15.9 % 8.0 % No significant difference 0.0 % Convalescent plasma Placebo No significant difference in the rate of disease progression within 15 days (30% vs. 31.9%; ARD -1.9, 95% CI -9.8 to 6) Secondary outcomes No significant difference in the rate of death with 30 days (1.9% vs. 0.4%; AD 1.6%, 95% CI -0.5 to 4.2) No significant difference in hospital-free days (28.3 days vs. 28.6 days; MD -0.3, 95% CI -1.1 to 0.4) No significant difference in worsening of symptoms based on the 5-category outpatient scale (41.6% vs. 45.7%; HR 0.9, 95% CI 0.69 to 1.17) Safety outcomes No significant difference in other adverse events. Significant differences in dyspnea (2.3% vs. 6.7%), infusion related reaction (5.8% vs. 0.4%). Conclusion In patients who were being treated in an emergency department for COVID-19 symptoms, convalescent plasma was not superior to placebo with respect to the rate of disease progression within 15 days. Reference Frederick K Korley, Valerie Durkalski-Mauldin, Sharon D Yeatts et al. Early Convalescent Plasma for High-Risk Outpatients with Covid-19. N Engl J Med. 2021 Nov 18;385(21):1951-1960. Open reference URL https://web.pathway.md/studies/recXSYYyWmQUskP17 2/2