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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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.