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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
Sponsor:
Information provided by (Responsible Party):
Emanuele Bosi, IRCCS San Raffaele

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
COVID-19 Virus Infection Drug: Interferon-ß-1a Combination Product: Standard of Care (SOC) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

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 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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Incidence of new oxygen use, non-invasive ventilation, or high flow oxygen devices during the trial [ Time Frame: From baseline to day 29 ]
  4. Oxygenation free days in the first 28 days [ Time Frame: From baseline to day 29 ]
  5. Ventilator free days in the first 28 days [ Time Frame: From baseline to day 29 ]
  6. Incidence of new mechanical ventilation use during the trial [ Time Frame: From baseline to day 29 ]
  7. Number of patients transferred to Intensive Care Unit (ICU) [ Time Frame: From baseline to day 29 ]
  8. Mortality rate [ Time Frame: From baseline to day 29 ]
  9. 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)

  10. Duration of hospital stay expressed in days [ Time Frame: From baseline to day 29 ]
  11. Viral load measured on plasma with RT-PCR [ Time Frame: Baseline, days 3, 5, 7, 9, 11, 13, 15, 21, 29 ]

Other Outcome Measures:
  1. Plasma and peripheral blood mononuclear cell messenger-RNA (mRNA) expression profile of interferon stimulated genes (ISG) [ Time Frame: Baseline, day 15 ]
  2. Antibodies to SARS-CoV-2 [ Time Frame: Baseline, days 7, 15, 29 ]
  3. Antibodies to IFN-β1a [ Time Frame: Baseline, days 7, 15, 29 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed consent signed
  2. Patients hospitalized with confirmed swab RT-PCR detection of SARS-CoV-2
  3. X-ray and/or CT diagnosed pneumonia
  4. Age >=18 years
  5. Clinical status defined as 3, 4 or 5 on the 7-point ordinal scale

Exclusion Criteria:

  1. Known allergy or hypersensitivity to IFNß-1a or IFNß-1b
  2. Presence of severe concomitant illnesses/medical conditions that in the physician opinion do not allow participation to the study
  3. Pregnant or lactating females
  4. History of major depression disorder or suicidal attempt or suicidal ideation
  5. Spontaneous blood alanine aminotransferase/aspartate aminotransferase (ALT/AST) levels > 5 times the upper limit of normal
  6. Clinical status defined as 1, 2, or 6 on the 7-point ordinal scale

Information from the National Library of Medicine

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


Contacts
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Contact: Emanuele Bosi, Professor 00390226432818 bosi.emanuele@hsr.it

Locations
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Italy
IRCCS Ospedale San Raffaele
Milano, Italy, 20132
Contact: Emanuele Bosi, Professor    00390226432821    bosi.emanuele@hsr.it   
Contact: Patrizia Rovere Querini, Professor    00390226426768    rovere.patrizia@hsr.it   
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
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Principal Investigator: Emanuele Bosi, Professor IRCCS Ospedale San Raffaele
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Responsible Party: Emanuele Bosi, Professor, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT04449380    
Other Study ID Numbers: INTERCOP
First Posted: June 26, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Virus Diseases
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents