Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19

• Status: Recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharming Technologies B.V.
• Treatments: Complement C1 Inhibitor Protein

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