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

Pharming Technologies B.V.38 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Confirmed Coronavirus Disease

Interventions

RuconestDRUG

Patients will be randomized to Ruconest or Standard of Care

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (4)

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 Township, New Jersey, United States

Outcomes

Primary Outcomes

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.

Time frame: 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

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

Time frame: Daily until day 14

Invasive (Mechanical) or Non-invasive Ventilation

Admission to ICU with invasive or non-invasive ventilation will be assessed.

Time frame: Daily until day 14.

Number of Days Hospitalized

Amount of days the patient is hospitalized during participation in the study.

Time frame: between D0 and D90

Data from ClinicalTrials.gov

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