Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19
Condition: Covid19
MeSH terms: COVID-19
Intervention: IFN beta-1a; Dexamethasone
Intervention description: Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised; Treated daily with dexamethasone 6 mg as an IV bolus for 6 days while hospitalised
Intervention MeSH terms: Dexamethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The study will be performed in a double-blind and randomized manner.
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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. 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:

          1. 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