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

NCT04449380 | Terminated Phase 2

• 1 other identifier: INTERCOP
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Virus Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Improvement in clinical severity score (a)

  Baseline, days 7, 15, 21, 29

• Improvement in clinical severity score (b)

  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

Other Outcomes (3)

• 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

Study Arms (2)

IFNβ 1a

EXPERIMENTAL

Drug: Interferon-ß-1a

Standard care

ACTIVE COMPARATOR

Combination Product: Standard of Care (SOC)

Interventions

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

Also known as: IFNß-1a

IFNβ 1a

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

Also known as: SOC

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Known allergy or hypersensitivity to IFNß-1a or IFNß-1b
• Presence of severe concomitant illnesses/medical conditions that in the physician opinion do not allow participation to the study
• Pregnant or lactating females
• History of major depression disorder or suicidal attempt or suicidal ideation
• 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

Sponsors & Collaborators

• Emanuele Bosi: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Related Publications (1)

• 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.

  PMID: 33225960 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Emanuele Bosi, Professor

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This is an interventional, monocentric, phase 2, randomized (2:1), open label, controlled clinical study

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 26, 2020
• Study Start: November 2, 2020
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Locations

IT (1)