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

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)

Sponsors

Lead Sponsor: Pharming Technologies B.V.

Source Pharming Technologies B.V.
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.

Overall Status Recruiting
Start Date 2020-11-30
Completion Date 2021-11-30
Primary Completion Date 2021-08-15
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Disease Severity on the 7-Point WHO Ordinal Scale 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
Secondary Outcome
Measure Time Frame
Clinical improvement Daily until day 14
Invasive or non-invasive ventilation Daily until day 14.
Acute Lung Injury Daily until day 14.
Enrollment 120
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ruconest

Description: 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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

85 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Jonathan Bernstein, MD Principal Investigator University of Cincinnati
Overall Contact

Last Name: Anurag Relan, MD

Phone: +31 71 5247 400

Email: [email protected]

Location
Facility: Status: Contact: Investigator: The Valley Hospital Rhama Reyes, BSN RN 201-447-8453 [email protected] Evan Leibowitz, MD Principal Investigator
Location Countries

United States

Verification Date

2020-08-01

Responsible Party

Type: Sponsor

Condition Browse
Number Of Arms 2
Arm Group

Label: Ruconest

Type: Experimental

Description: 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.

Label: Standard of Care

Type: Other

Description: SOC

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Investigator)

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