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.
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.
Drug: Ruconest
Patients will be randomized to Ruconest or Standard of Care
Other Name: SOC
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
The Valley Hospital
Ridgewood, New Jersey, United States
Jonathan Bernstein, MD, Principal Investigator
University of Cincinnati