Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Multi-Center, Double-Blind, Randomized and Controlled Study of the Safety and Efficacy of Intravenous Recombinant Human Interferon Beta-1a in Comparison to Dexamethasone for the Treatment of Hospitalized Patients With COVID-19 Infection

Conditions
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Covid19

Intervention / Treatment
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* Drug: IFN beta-1a
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV IFN beta-1a<br>Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline. | Drug: IFN beta-1a<br>* Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised<br>|
| Active Comparator: IV Dexamethasone<br>Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone. | Drug: Dexamethasone<br>* Treated daily with dexamethasone 6 mg as an IV bolus for 6 days while hospitalised<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Status at Day 14 (First Day of Study Drug is Day 1) as Measured by WHO 9-point Ordinal Scale | WHO 9-point ordinal scale: 0 - No detectable infection - Not hospitalized, no limitations on activities - Not hospitalized, limitation on activities - Hospitalized, not requiring supplemental oxygen - Hospitalized, requiring supplemental oxygen - Hospitalized, on non-invasive ventilation or high flow oxygen devices - Hospitalized, on invasive mechanical ventilation - Hospitalized, on mechanical ventilation plus additional organ support: renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO) - Death | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital Mortality at Day 28 and Day 90 | Percentage of participants per study group that die when in still hospital at Day 28 or Day 90 of the trial | Day 28 and Day 90 | 
| Overall (All-cause) Mortality at Day 28 and Day 90 | Percentage of participants per study group that die within 28 days or 90 days from starting the study | Day 28 and Day 90 |