At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 38 enrolled
Drug / intervention
Ruconestdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Ruconest for Confirmed Coronavirus Disease. Completed, enrolled 38 participants across 4 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConfirmed Coronavirus Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedAug 2020
Enrollment StartNov 2020
Primary CompletionSep 2021
Study CompletionDec 2021
TodayJul 2026
First PostedAug 28, 2020
Enrollment StartNov 30, 2020
Primary CompletionSep 7, 2021
Study CompletionDec 1, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.8 years ago
Interventions
Ruconestdrug
Patients will be randomized to Ruconest or Standard of Care