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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2021-03-30

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID-19 Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IFNβ 1a

Group Type EXPERIMENTAL

Interferon-ß-1a

Intervention Type 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

Standard care

Group Type ACTIVE_COMPARATOR

Standard of Care (SOC)

Intervention Type COMBINATION_PRODUCT

Any pharmacological (e.g. antibiotics, etc.) and non-pharmacological (e.g. oxygen, ventilation, etc.) treatments prescribed on clinical grounds

Interventions

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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

Intervention Type DRUG

Standard of Care (SOC)

Any pharmacological (e.g. antibiotics, etc.) and non-pharmacological (e.g. oxygen, ventilation, etc.) treatments prescribed on clinical grounds

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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IFNß-1a SOC

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No