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

Purpose

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.

Condition

  • Confirmed Coronavirus Disease

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Drug: Ruconest
    Patients will be randomized to Ruconest or Standard of Care
    Other names:
    • SOC
Other
Standard of Care 		SOC
  • Drug: Ruconest
    Patients will be randomized to Ruconest or Standard of Care
    Other names:
    • SOC

Recruiting Locations

More Details

NCT ID
NCT04530136
Status
Completed
Sponsor
Pharming Technologies B.V.

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.