Clinical trial NCT04530136: Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19
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 US
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Confirmed Coronavirus Disease
Lead sponsor: Pharming Technologies B.V.
Sponsor class: INDUSTRY
First posted: 2020-08-28
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Each Score on WHO 7-point Outcome Scale at Day 7
timeFrame: 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 outcomes:
measure: Time to Clinical Improvement
timeFrame: Daily until day 14
measure: Invasive (Mechanical) or Non-invasive Ventilation
timeFrame: Daily until day 14.
measure: Number of Days Hospitalized
timeFrame: between D0 and D90
Other outcomes:
Locations:
city: Marlton
country: United States
facility: Virtua Marlton Hospital
state: New Jersey
city: Mount Holly
country: United States
facility: Virtua Memorial Hospital
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Voorhees
country: United States
facility: Virtua Voorhees Hospital
state: New Jersey
Study officials:
affiliation: University of Cincinnati
name: Jonathan Bernstein, MD
role: PRINCIPAL_INVESTIGATOR
References: