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

Phase 2

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Standard of Care	Ruconest	SOC
Ruconest	Ruconest	Patients receive (150 U/ml) of Ruconest at a 50 U/kg dose (max dose of 4200 U) as a slow intravenous injection via a peripheral every 12 hours; for 4 days. A total of 8 doses will be administered.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Each Score on WHO 7-point Outcome Scale at Day 7	Assessed on each day after enrollment (worst status) with the use of the WHO Ordinal Scale and the score on day 7 will be analyzed stratified by its baseline value	The disease severity on the 7-point WHO Ordinal Scale on Day 7 was the primary objective of this study. This endpoint had been suggested by the WHO for clinical trials in patients with Covid-19. The ordinal scale measures illness severity over time. The higher score, the worst outcome: meaning score 1, no limitation in activities and score 7, death.

Secondary Outcome Measures

Name	Time	Method
Number of Days Hospitalized	between D0 and D90	Amount of days the patient is hospitalized during participation in the study.
Invasive (Mechanical) or Non-invasive Ventilation	Daily until day 14.	Admission to ICU with invasive or non-invasive ventilation will be assessed.
Time to Clinical Improvement	Daily until day 14	Time from randomization to an improvement of (at least) two (score) points on the seven-category WHO Ordinal Scale or live discharge from hospital whichever came first within 14 days after enrollment

Locations (4): Virtua Marlton Hospital
🇺🇸
Marlton, New Jersey, United States
Virtua Voorhees Hospital
🇺🇸
Voorhees, New Jersey, United States
Virtua Memorial Hospital
🇺🇸
Mount Holly, New Jersey, United States
The Valley Hospital
🇺🇸
Ridgewood, New Jersey, United States