Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With CoronavirUS

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Faron Pharmaceuticals Ltd
• Treatments: Dexamethasone; Interferon-beta

Criteria

Inclusion Criteria:

1. 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. 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:

1. Unable to screen, randomize and administer study drug within 48 hours from arrival to hospital

2. Systemic corticosteroid or baricitinib 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