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Trial record 1 of 1 for:    NCT04530136
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Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19

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ClinicalTrials.gov Identifier: NCT04530136
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : December 10, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Confirmed Coronavirus Disease Drug: Ruconest Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : November 30, 2020
Estimated Primary Completion Date : August 15, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: SOC

Standard of Care
SOC
Drug: Ruconest
Patients will be randomized to Ruconest or Standard of Care
Other Name: SOC




Primary Outcome Measures :
  1. Disease Severity on the 7-Point WHO Ordinal Scale [ Time Frame: 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 primary endpoint will be the disease severity on the 7-point WHO Ordinal Scale on day 7. This endpoint has been suggested by WHO for clinical trials in patients with COVID-19


Secondary Outcome Measures :
  1. Clinical improvement [ Time Frame: Daily until day 14 ]
    at least 2 points Ordinal Scale for Clinical Improvement, clinical severity will be assessed.

  2. Invasive or non-invasive ventilation [ Time Frame: Daily until day 14. ]
    Admission to ICU with invasive or non-invasive ventilation or death will be assessed.

  3. Acute Lung Injury [ Time Frame: Daily until day 14. ]
    Patients with ALI within 14 days after enrollment, PaO2/FiO2 will be determined daily. This is only relevant for patients with arterial blood gas sampling performed in the ICU or rarely in the medical unit.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04530136


Contacts
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Contact: Anurag Relan, MD +31 71 5247 400 medical-information@pharming.com
Contact: Leisa Waynick, BSBA 908-947-6291 L.Waynick@pharming.com

Locations
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United States, New Jersey
The Valley Hospital Recruiting
Ridgewood, New Jersey, United States, 07450
Contact: Rhama Reyes, BSN RN    201-447-8453    rreyes2@valleyhealth.com   
Principal Investigator: Evan Leibowitz, MD         
Sponsors and Collaborators
Pharming Technologies B.V.
Investigators
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Principal Investigator: Jonathan Bernstein, MD University of Cincinnati
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Responsible Party: Pharming Technologies B.V.
ClinicalTrials.gov Identifier: NCT04530136    
Other Study ID Numbers: C1 6201
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Complement C1 Inhibitor Protein
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs