Clinical trial NCT04449380: Clinical Study for the Treatment With Interferon-ß-1a (IFNß-1a) of COVID-19 Patients
Official title: Randomized, Controlled, Open Label, Phase 2 Clinical Trial of Interferon-β-1a (IFNβ-1a) in COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19 Virus Infection
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2020-06-26
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an interventional, monocentric, phase 2, randomized (2:1), open label, controlled clinical study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to negative conversion of SARS-CoV-2 nasopharyngeal swab
timeFrame: From baseline to day 29
Secondary outcomes:
measure: Improvement in clinical severity score (a)
timeFrame: Baseline, days 7, 15, 21, 29
measure: Improvement in clinical severity score (b)
timeFrame: Baseline, days 7, 15, 21, 29
measure: Incidence of new oxygen use, non-invasive ventilation, or high flow oxygen devices during the trial
timeFrame: From baseline to day 29
measure: Oxygenation free days in the first 28 days
timeFrame: From baseline to day 29
measure: Ventilator free days in the first 28 days
timeFrame: From baseline to day 29
measure: Incidence of new mechanical ventilation use during the trial
timeFrame: From baseline to day 29
measure: Number of patients transferred to Intensive Care Unit (ICU)
timeFrame: From baseline to day 29
measure: Mortality rate
timeFrame: From baseline to day 29
measure: Changes from baseline in pulmonary computed tomography (CT) imaging severity score
timeFrame: Baseline, day 21; extra follow up at 90 days
measure: Duration of hospital stay expressed in days
timeFrame: From baseline to day 29
measure: Viral load measured on plasma with RT-PCR
timeFrame: Baseline, days 3, 5, 7, 9, 11, 13, 15, 21, 29
Other outcomes:
measure: Plasma and peripheral blood mononuclear cell messenger-RNA (mRNA) expression profile of interferon stimulated genes (ISG)
timeFrame: Baseline, day 15
measure: Antibodies to SARS-CoV-2
timeFrame: Baseline, days 7, 15, 29
measure: Antibodies to IFN-β1a
timeFrame: Baseline, days 7, 15, 29
Locations:
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
affiliation: IRCCS Ospedale San Raffaele
name: Emanuele Bosi, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.