Official Title
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 United States (PROTECT-COVID-19-US)
Brief 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.

Completed
Confirmed Coronavirus Disease

Drug: Ruconest

Patients will be randomized to Ruconest or Standard of Care
Other Name: SOC

Eligibility Criteria

Inclusion Criteria:

- Age 18-85 years,

- Admitted to the hospital because of confirmed positive SARS-CoV-2 (COVID-19
infection).

- Evidence of pulmonary involvement on CT scan or X-Ray of the chest,

- Symptom onset within the previous 10 days AND at least one additional risk factor for
progression to mechanical ventilation: 1) arterial hypertension, 2) >50 years, 3)
obesity (BMI>30.0 kg/m2), 4) history of cardiovascular disease, 5) chronic pulmonary
disease, 7) chronic renal disease, 6) C-reactive protein of >35mg/L, 7) oxygen
saturation at rest in ambient air of <94%

Exclusion Criteria:

- Contraindications to the class of drugs under study (C1 esterase inhibitor);

- History or suspicion of allergy to rabbits;

- Women who are of childbearing potential and not using methods of contraception during
the entire study period;

- Pregnant or breastfeeding females or has a positive serum β-human chorionic
gonadotropin (hCG) pregnancy test at screening;

- Chronic liver disease (any Child-Pugh score B or C);

- Currently admitted to an ICU or expected admission within the next 24 hours; and

- Currently receiving invasive or non-invasive ventilation

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 85 Years
Countries
United States
Locations

The Valley Hospital
Ridgewood, New Jersey, United States

Jonathan Bernstein, MD, Principal Investigator
University of Cincinnati

Pharming Technologies B.V.
NCT Number
MeSH Terms
COVID-19
Complement C1 Inhibitor Protein