drugset / Trial / NCT04530136

Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19

NCT04530136 ↗

Phase 2 Completed 38 enrolled Pharming Technologies B.V.
RandomizedParallel-groupSingle-blindTreatment

Summary

The primary purpose of this study is to evaluate if adding rhC1-INH to standard of care (SOC) in patients admitted for stage II COVID-19 infection may reduce the risk of disease progression, i.e. ALI requiring mechanical ventilation, or increase the chance of a faster clinical improvement compared to SOC alone.

Timeline

Start
2020-11-30
Primary completion
2021-09-07
Completion
2021-12-01

Outcome

Met primary endpoint

registry analysis (superiority test); Ruconest vs Standard of Care; p = 0.0346; Wilcoxon rank test NCT04530136 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject recombinant human C1 inhibitor Protein / enzyme biologic 50 iu/kg Intravenous

Indications