Clinical Study for the Treatment With Interferon-ß-1a (IFNß-1a) of COVID-19 Patients (INTERCOP)
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|ClinicalTrials.gov Identifier: NCT04449380|
Recruitment Status : Not yet recruiting
First Posted : June 26, 2020
Last Update Posted : July 29, 2020
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|
|COVID-19 Virus Infection||Drug: Interferon-ß-1a Combination Product: Standard of Care (SOC)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is an interventional, monocentric, phase 2, randomized (2:1), open label, controlled clinical study|
|Masking:||None (Open Label)|
|Official Title:||Randomized, Controlled, Open Label, Phase 2 Clinical Trial of Interferon-β-1a (IFNβ-1a) in COVID-19 Patients|
|Estimated Study Start Date :||September 2020|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||June 2021|
|Experimental: IFNβ 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 Name: IFNß-1a
|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 Name: SOC
- Time to negative conversion of SARS-CoV-2 nasopharyngeal swab [ Time Frame: From baseline to day 29 ]Viral load will be measured by Real Time-Polymerase Chain Reaction (RT-PCR)
- Improvement in clinical severity score (a) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: From baseline to day 29 ]
- Oxygenation free days in the first 28 days [ Time Frame: From baseline to day 29 ]
- Ventilator free days in the first 28 days [ Time Frame: From baseline to day 29 ]
- Incidence of new mechanical ventilation use during the trial [ Time Frame: From baseline to day 29 ]
- Number of patients transferred to Intensive Care Unit (ICU) [ Time Frame: From baseline to day 29 ]
- Mortality rate [ Time Frame: From baseline to day 29 ]
- Changes from baseline in pulmonary computed tomography (CT) imaging severity score [ Time Frame: 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 [ Time Frame: From baseline to day 29 ]
- Viral load measured on plasma with RT-PCR [ Time Frame: Baseline, days 3, 5, 7, 9, 11, 13, 15, 21, 29 ]
- Plasma and peripheral blood mononuclear cell messenger-RNA (mRNA) expression profile of interferon stimulated genes (ISG) [ Time Frame: Baseline, day 15 ]
- Antibodies to SARS-CoV-2 [ Time Frame: Baseline, days 7, 15, 29 ]
- Antibodies to IFN-β1a [ Time Frame: Baseline, days 7, 15, 29 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04449380
|Contact: Emanuele Bosi, Professoremail@example.com|
|Principal Investigator:||Emanuele Bosi, Professor||IRCCS Ospedale San Raffaele|