Status:
TERMINATED
Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19
Lead Sponsor:
Faron Pharmaceuticals Ltd
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This double-blinded, randomized study is being conducted to see if the investigational new drug called FP-1201-lyo - intravenous Interferon beta-1a, hereafter IV IFN beta-1a, can help patients recover...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Positive SARS-CoV-2 test by PCR (polymerase chain reaction) or other diagnostic method within the past 7 days
- Admission to hospital with respiratory symptoms of COVID-19 requiring hospital care and oxygen supplementation (≤ 8L/min)
- Respiratory symptom onset no more than 7 days prior to hospital arrival
- Informed consent from the subject or the subject's personal legal representative or a professional legal representative must be available
Exclusion
- Unable to screen, randomize and administer study drug within 48 hours from arrival to hospital
- Systemic corticosteroid, baricitinib or tofacitinib (or other JAK-STAT signalling pathway inhibitors) therapy within 7 days prior to arrival to hospital or planned for the next days
- Known hypersensitivity or contraindication to natural or recombinant IFN-beta-1a or its excipients, or to dexamethasone or its excipients
- Currently receiving IFN-beta-1a therapy
- Home assisted ventilation (via tracheotomy or non-invasive) except for Continuous Positive Airway Pressure (CPAP) / Bilevel Positive Airway Pressure (BIPAP) used only for sleep-disordered breathing
- Participation in another concurrent interventional pharmacotherapy trial during the study period
- Decision to withhold life-sustaining treatment; patient not committed to full support (except DNR after cardiac arrest only)
- Woman known to be pregnant, lactating or with a positive pregnancy test (urine or serum test)
- Subject is not expected to survive for 24 hours
- Subject has liver failure (Child-Pugh grade C)
- Any clinical condition that in the opinion of the attending clinician or Investigator would present a risk for the subject to participate in the study
Key Trial Info
Start Date :
August 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2022
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04860518
Start Date
August 23 2021
End Date
April 4 2022
Last Update
July 21 2023
Active Locations (4)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
3
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
4
Vanderbilt University School of Medicine
Nashville, Tennessee, United States, 37232