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

NCT04530136 | Completed Phase 2 Results FDA Drug

• 1 other identifier: C1 6201
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Confirmed Coronavirus Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to Clinical Improvement

  Daily until day 14

• Invasive (Mechanical) or Non-invasive Ventilation

  Daily until day 14.

• Number of Days Hospitalized

  between D0 and D90

Study Arms (2)

Ruconest

EXPERIMENTAL

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.

Drug: Ruconest

Standard of Care

OTHER

SOC

Drug: Ruconest

Interventions

Ruconest DRUG

Patients will be randomized to Ruconest or Standard of Care

Also known as: SOC

Ruconest; Standard of Care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharming Technologies B.V.: lead

Study Sites (4)

Virtua Marlton Hospital

Marlton, New Jersey, 08053, United States

Location

Virtua Memorial Hospital

Mount Holly, New Jersey, 08060, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Virtua Voorhees Hospital

Voorhees Township, New Jersey, 08043, United States

Location

MeSH Terms

Interventions

conestat alfa

Results Point of Contact

• Title: Anurag Relan, MD
• Organization: Pharming Technologies BV

a.relan@pharming.com

0031 (0)71 5247400

Study Officials

• Jonathan Bernstein, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 28, 2020
• Study Start: November 30, 2020
• Primary Completion: September 7, 2021
• Study Completion: December 1, 2021
• Last Updated: February 16, 2024
• Results First Posted: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)