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

Pharming Healthcare

Status and phase: Completed; Phase 2

Conditions: Confirmed Coronavirus Disease

Treatments: Drug: Ruconest

Study type: Interventional

Funder types: Industry

Identifiers

NCT04530136

C1 6201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Ruconest

Experimental group

Description:

Patients receive (150 U/ml) of Ruconest at a 50 U/kg dose (max dose of 4200 U) as a slow intravenous injection via a peripheral every 12 hours; for 4 days. A total of 8 doses will be administered.

Treatment:

Drug: Ruconest

Standard of Care

Other group

Description:

SOC

Treatment:

Drug: Ruconest