Confirmed Coronavirus Disease Clinical Trial
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
| Verified date | February 2024 |
| Source | Pharming Technologies B.V. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 38 |
| Est. completion date | December 1, 2021 |
| Est. primary completion date | September 7, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | 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 ß-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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Virtua Marlton Hospital | Marlton | New Jersey |
| United States | Virtua Memorial Hospital | Mount Holly | New Jersey |
| United States | The Valley Hospital | Ridgewood | New Jersey |
| United States | Virtua Voorhees Hospital | Voorhees | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Pharming Technologies B.V. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Each Score on WHO 7-point Outcome Scale at Day 7 | The disease severity on the 7-point WHO Ordinal Scale on Day 7 was the primary objective of this study. This endpoint had been suggested by the WHO for clinical trials in patients with Covid-19. The ordinal scale measures illness severity over time. The higher score, the worst outcome: meaning score 1, no limitation in activities and score 7, death. | 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 | Time to Clinical Improvement | Time from randomization to an improvement of (at least) two (score) points on the seven-category WHO Ordinal Scale or live discharge from hospital whichever came first within 14 days after enrollment | Daily until day 14 | |
| Secondary | Invasive (Mechanical) or Non-invasive Ventilation | Admission to ICU with invasive or non-invasive ventilation will be assessed. | Daily until day 14. | |
| Secondary | Number of Days Hospitalized | Amount of days the patient is hospitalized during participation in the study. | between D0 and D90 |