Clinical Study for the Treatment With Interferon-ß-1a (IFNß-1a) of COVID-19 Patients

Study Overview
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Brief Summary
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Pharmacological therapies of proven efficacy in coronavirus disease 2019 (COVID-19) are still lacking. Since two clinical stages of COVID-19 are emerging, an early one with typical clinical characteristics of a viral infection (fever, malaise, cough) and a later one with pneumonia leading to progressive respiratory failure, associated with heavy, cytokine-mediated, inflammation, an intervention by a compound possessing both antiviral activity and immunomodulatory effects would be most effective at the earliest possible stage. The purpose of this clinical trial is to test the efficacy of Interferon-β-1a (IFNβ-1a), in COVID-19 patients in an open label, randomized clinical trial. The design of the study is to test IFNβ-1a in addition to standard of care compared with standard of care alone. The primary outcome is the time to negative conversion of Severe Acute Respiratory Syndrome-CoronaVirus-2 (SARS-CoV-2) nasopharyngeal swabs.

Official Title
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Randomized, Controlled, Open Label, Phase 2 Clinical Trial of Interferon-β-1a (IFNβ-1a) in COVID-19 Patients

Conditions
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COVID-19 Virus Infection

Intervention / Treatment
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* Drug: Interferon-ß-1a
* Combination Product: Standard of Care (SOC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent signed Patients hospitalized with confirmed swab RT-PCR detection of SARS-CoV-2 X-ray and/or CT diagnosed pneumonia Age >=18 years Clinical status defined as 3, 4 or 5 on the 7-point ordinal scale Exclusion Criteria: Known allergy or hypersensitivity to IFNß-1a or IFNß-1b Presence of severe concomitant illnesses/medical conditions that in the physician opinion do not allow participation to the study Pregnant or lactating females History of major depression disorder or suicidal attempt or suicidal ideation Spontaneous blood alanine aminotransferase/aspartate aminotransferase (ALT/AST) levels > 5 times the upper limit of normal Clinical status defined as 1, 2, or 6 on the 7-point ordinal scale

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is an interventional, monocentric, phase 2, randomized (2:1), open label, controlled clinical study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IFNβ 1a<br> | Drug: Interferon-ß-1a<br>* IFNβ-1a will be administered subcutaneously at a dose of 44 mcg (equivalent to 12 million international units), three times per week at least 48 hours apart, for a total of two weeks. All patients will receive a total dose of 264 mcg (72 million international units) under physician control<br>* Other names: IFNß-1a;|
| Active Comparator: Standard care<br> | Combination Product: Standard of Care (SOC)<br>* Any pharmacological (e.g. antibiotics, etc.) and non-pharmacological (e.g. oxygen, ventilation, etc.) treatments prescribed on clinical grounds<br>* Other names: SOC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to negative conversion of SARS-CoV-2 nasopharyngeal swab | Viral load will be measured by Real Time-Polymerase Chain Reaction (RT-PCR) | From baseline to day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in clinical severity score (a) | Defined as percentage of patients reporting each severity rating on a 7-point ordinal scale | Baseline, days 7, 15, 21, 29 | 
| Improvement in clinical severity score (b) | Defined as the time to clinical improvement of two points from the time of randomization on a 7-category ordinal scale or live discharge from the hospital, whichever comes first | Baseline, days 7, 15, 21, 29 | 
| Incidence of new oxygen use, non-invasive ventilation, or high flow oxygen devices during the trial |  | From baseline to day 29 | 
| Oxygenation free days in the first 28 days |  | From baseline to day 29 | 
| Ventilator free days in the first 28 days |  | From baseline to day 29 | 
| Incidence of new mechanical ventilation use during the trial |  | From baseline to day 29 | 
| Number of patients transferred to Intensive Care Unit (ICU) |  | From baseline to day 29 | 
| Mortality rate |  | From baseline to day 29 | 
| Changes from baseline in pulmonary computed tomography (CT) imaging severity score | Measured with artificial intelligence and expressed as cc and percent values of diseased lung (lung consolidation, ground glass opacities and disease free) | Baseline, day 21; extra follow up at 90 days | 
| Duration of hospital stay expressed in days |  | From baseline to day 29 | 
| Viral load measured on plasma with RT-PCR |  | Baseline, days 3, 5, 7, 9, 11, 13, 15, 21, 29 |