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

Emanuele Bosi

Status and phase: Terminated; Phase 2

Conditions: COVID-19 Virus Infection

Treatments: Drug: Interferon-ß-1a; Combination Product: Standard of Care (SOC)

Study type: Interventional

Funder types: Other

Identifiers

NCT04449380

INTERCOP

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

IFNβ 1a

Experimental group

Treatment:

Drug: Interferon-ß-1a

Standard care

Active Comparator group

Treatment:

Combination Product: Standard of Care (SOC)