NCT04530136

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

Recombinant Human C1 Esterase Inhibitor (Ruconest®) in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19: a Randomized, Parallel-group, Open-label, Multi-center Pilot Trial in the US

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Pharming Technologies B.V. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients fulfilling all eligibility criteria will be randomized in a 2:1 ratio in an open-label controlled design to treatment with rhC1-INH in addition to SOC or SOC only starting on day 0. The first rhC1-INH treatment will be administered on the same day and continued for a total of 4 days.

Conditions

• Confirmed Coronavirus Disease

Interventions

Type	Name	Description
DRUG	Ruconest	Patients will be randomized to Ruconest or Standard of Care

Timeline

• Start date: 2020-11-30
• Primary completion: 2021-09-07
• Completion: 2021-12-01
• First posted: 2020-08-28
• Last updated: 2024-02-16
• Results posted: 2024-02-16

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study