INTERCOP: Clinical Study for the Treatment With Interferon-ß-1a (IFNß-1a) of COVID-19 Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IFNβ 1a
|
Drug: Interferon-ß-1a
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
Other Names:
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| Active Comparator: Standard care
|
Combination Product: Standard of Care (SOC)
Any pharmacological (e.g. antibiotics, etc.) and non-pharmacological (e.g. oxygen, ventilation, etc.) treatments prescribed on clinical grounds
Other Names:
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Outcome Measures
Primary Outcome Measures
- Time to negative conversion of SARS-CoV-2 nasopharyngeal swab [From baseline to day 29]
Viral load will be measured by Real Time-Polymerase Chain Reaction (RT-PCR)
Secondary Outcome Measures
- Improvement in clinical severity score (a) [Baseline, days 7, 15, 21, 29]
Defined as percentage of patients reporting each severity rating on a 7-point ordinal scale
- Improvement in clinical severity score (b) [Baseline, days 7, 15, 21, 29]
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
- 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 [Baseline, day 21; extra follow up at 90 days]
Measured with artificial intelligence and expressed as cc and percent values of diseased lung (lung consolidation, ground glass opacities and disease free)
- 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]
Other Outcome Measures
- Plasma and peripheral blood mononuclear cell messenger-RNA (mRNA) expression profile of interferon stimulated genes (ISG) [Baseline, day 15]
- Antibodies to SARS-CoV-2 [Baseline, days 7, 15, 29]
- Antibodies to IFN-β1a [Baseline, days 7, 15, 29]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Informed consent signed
-
Patients hospitalized with confirmed swab RT-PCR detection of SARS-CoV-2
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X-ray and/or CT diagnosed pneumonia
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Age >=18 years
-
Clinical status defined as 3, 4 or 5 on the 7-point ordinal scale
Exclusion Criteria:
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Known allergy or hypersensitivity to IFNß-1a or IFNß-1b
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Presence of severe concomitant illnesses/medical conditions that in the physician opinion do not allow participation to the study
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Pregnant or lactating females
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History of major depression disorder or suicidal attempt or suicidal ideation
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IRCCS Ospedale San Raffaele | Milano | Italy | 20132 |
Sponsors and Collaborators
- Emanuele Bosi
Investigators
- Principal Investigator: Emanuele Bosi, Professor, IRCCS Ospedale San Raffaele
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INTERCOP