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

COVID-19 Virus Infection Clinical Trial

— INTERCOP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04449380
• Other study ID #: INTERCOP
• Status: Terminated
• Phase: Phase 2
• Start date: November 2, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: April 2021
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19 Virus Infection
• Virus Diseases

Intervention

Drug:
• Interferon-ß-1a
IFNß-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

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

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Emanuele Bosi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma and peripheral blood mononuclear cell messenger-RNA (mRNA) expression profile of interferon stimulated genes (ISG)		Baseline, day 15
Other	Antibodies to SARS-CoV-2		Baseline, days 7, 15, 29
Other	Antibodies to IFN-ß1a		Baseline, days 7, 15, 29
Primary	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	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
Secondary	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
Secondary	Incidence of new oxygen use, non-invasive ventilation, or high flow oxygen devices during the trial		From baseline to day 29
Secondary	Oxygenation free days in the first 28 days		From baseline to day 29
Secondary	Ventilator free days in the first 28 days		From baseline to day 29
Secondary	Incidence of new mechanical ventilation use during the trial		From baseline to day 29
Secondary	Number of patients transferred to Intensive Care Unit (ICU)		From baseline to day 29
Secondary	Mortality rate		From baseline to day 29
Secondary	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
Secondary	Duration of hospital stay expressed in days		From baseline to day 29
Secondary	Viral load measured on plasma with RT-PCR		Baseline, days 3, 5, 7, 9, 11, 13, 15, 21, 29