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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IFNβ 1a | Experimental |
| |
| Standard care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon-ß-1a | Drug | 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 |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emanuele Bosi, Professor | IRCCS Ospedale San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale San Raffaele | Milan | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33225960 | Derived | Bosi E, Bosi C, Rovere Querini P, Mancini N, Calori G, Ruggeri A, Canzonieri C, Callegaro L, Clementi M, De Cobelli F, Filippi M, Bregni M. Interferon beta-1a (IFNbeta-1a) in COVID-19 patients (INTERCOP): study protocol for a randomized controlled trial. Trials. 2020 Nov 23;21(1):939. doi: 10.1186/s13063-020-04864-4. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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This is an interventional, monocentric, phase 2, randomized (2:1), open label, controlled clinical study
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|
|
| Standard of Care (SOC) | Combination Product | Any pharmacological (e.g. antibiotics, etc.) and non-pharmacological (e.g. oxygen, ventilation, etc.) treatments prescribed on clinical grounds |
|
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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 |
| Antibodies to IFN-β1a |
| Baseline, days 7, 15, 29 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |