Phase 2
N=38
Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19
Confirmed Coronavirus Disease
Bottom Line
View on ClinicalTrials.gov: NCT04530136 ↗Enrolled (actual)
38
Serious AEs
13.2%
Results posted
Feb 2024
Primary outcome: Primary: Number of Participants With Each Score on WHO 7-point Outcome Scale at Day 7 — 6; 0; 20; 8 Participants — p=0.0346
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ruconest (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pharming Technologies B.V.
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Each Score on WHO 7-point Outcome Scale at Day 7 |
6; 0; 20; 8; 0; 0 | 0.0346 sig |
| SECONDARY Time to Clinical Improvement |
3.32; 4.91 | 0.4441 |
| SECONDARY Invasive (Mechanical) or Non-invasive Ventilation |
0; 2; 12; 7 | 0.1021 |
| SECONDARY Number of Days Hospitalized |
5.38; 11.27 | 0.1615 |
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.
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
Data sourced from ClinicalTrials.gov (NCT04530136). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.