Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19
Purpose
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 more quickly from COVID-19 and prevent worsening of the condition. To understand if IV IFN beta-1a can help treat patients with COVID-19, this study drug will be compared to dexamethasone. Study subjects will be treated daily with IV IFN beta-1a 10 μg or IV dexamethasone for 6 consecutive days while hospitalized and will undergo daily assessments while in hospital for a maximum of 28 days. Study specific assessments will be collected at pre-dose Day 1 through Day 28 (PD and PIM assessments), in addition, clinical routine assessments will be utilized for safety and efficacy assessments.
Condition
- Covid19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age ≥18 years 2. Positive SARS-CoV-2 test by PCR (polymerase chain reaction) or other diagnostic method within the past 7 days 3. Admission to hospital with respiratory symptoms of COVID-19 requiring hospital care and oxygen supplementation (≤ 8L/min) 4. Respiratory symptom onset no more than 7 days prior to hospital arrival 5. Informed consent from the subject or the subject's personal legal representative or a professional legal representative must be available
Exclusion Criteria
- Unable to screen, randomize and administer study drug within 48 hours from arrival to hospital 2. 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 3. Known hypersensitivity or contraindication to natural or recombinant IFN-beta-1a or its excipients, or to dexamethasone or its excipients 4. Currently receiving IFN-beta-1a therapy 5. 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 6. Participation in another concurrent interventional pharmacotherapy trial during the study period 7. Decision to withhold life-sustaining treatment; patient not committed to full support (except DNR after cardiac arrest only) 8. Woman known to be pregnant, lactating or with a positive pregnancy test (urine or serum test) 9. Subject is not expected to survive for 24 hours 10. Subject has liver failure (Child-Pugh grade C) 11. 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- The study will be performed in a double-blind and randomized manner.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental IV IFN beta-1a |
Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline. |
|
|
Active Comparator IV Dexamethasone |
Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone. |
|
More Details
- Status
- Terminated
- Sponsor
- Faron Pharmaceuticals Ltd