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

Phase 2

Terminated

• Conditions: COVID-19 Virus Infection
• Interventions: Drug: Interferon-ß-1a; Combination Product: Standard of Care (SOC)

• Registration Number: NCT04449380
• Lead Sponsor: Emanuele Bosi

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-23
• Study First Submitted QC: 2020-06-25
• Study First Posted: 2020-06-26
• Study Start: 2020-11-02
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IFNβ 1a	Interferon-ß-1a	-
Standard care	Standard of Care (SOC)	-

Primary Outcome Measures

Name	Time	Method
Time to negative conversion of SARS-CoV-2 nasopharyngeal swab	From baseline to day 29	Viral load will be measured by Real Time-Polymerase Chain Reaction (RT-PCR)

Secondary Outcome Measures

Name	Time	Method
Number of patients transferred to Intensive Care Unit (ICU)	From baseline to day 29
Oxygenation free days in the first 28 days	From baseline to day 29
Improvement in clinical severity score (a)	Baseline, days 7, 15, 21, 29	Defined as percentage of patients reporting each severity rating on a 7-point ordinal scale
Changes from baseline in pulmonary computed tomography (CT) imaging severity score	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)
Incidence of new oxygen use, non-invasive ventilation, or high flow oxygen devices during the trial	From baseline to day 29
Mortality rate	From baseline to day 29
Duration of hospital stay expressed in days	From baseline to day 29
Viral load measured on plasma with RT-PCR	Baseline, days 3, 5, 7, 9, 11, 13, 15, 21, 29
Ventilator free days in the first 28 days	From baseline to day 29
Incidence of new mechanical ventilation use during the trial	From baseline to day 29
Improvement in clinical severity score (b)	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

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milano, Italy