Status:
COMPLETED
Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19
Lead Sponsor:
Pharming Technologies B.V.
Conditions:
Confirmed Coronavirus Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04530136
Start Date
November 30 2020
End Date
December 1 2021
Last Update
February 16 2024
Active Locations (4)
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1
Virtua Marlton Hospital
Marlton, New Jersey, United States, 08053
2
Virtua Memorial Hospital
Mount Holly, New Jersey, United States, 08060
3
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
4
Virtua Voorhees Hospital
Voorhees Township, New Jersey, United States, 08043