CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Interferon-ß-1aWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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Name (Synonyms) Correlation
drug2321 Standard of Care (SOC) Wiki 0.58

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D014777 Virus Diseases NIH 0.12

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 Randomized, Controlled, Open Label, Phase 2 Clinical Trial of Interferon-β-1a (IFNβ-1a) in COVID-19 Patients

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.

NCT04449380 COVID-19 Virus Infection Drug: Interferon-ß-1a Combination Product: Standard of Care (SOC)
MeSH:Virus Diseases

Primary Outcomes

Description: Viral load will be measured by Real Time-Polymerase Chain Reaction (RT-PCR)

Measure: Time to negative conversion of SARS-CoV-2 nasopharyngeal swab

Time: From baseline to day 29

Secondary Outcomes

Description: Defined as percentage of patients reporting each severity rating on a 7-point ordinal scale

Measure: Improvement in clinical severity score (a)

Time: Baseline, days 7, 15, 21, 29

Description: 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

Measure: Improvement in clinical severity score (b)

Time: Baseline, days 7, 15, 21, 29

Measure: Incidence of new oxygen use, non-invasive ventilation, or high flow oxygen devices during the trial

Time: From baseline to day 29

Measure: Oxygenation free days in the first 28 days

Time: From baseline to day 29

Measure: Ventilator free days in the first 28 days

Time: From baseline to day 29

Measure: Incidence of new mechanical ventilation use during the trial

Time: From baseline to day 29

Measure: Number of patients transferred to Intensive Care Unit (ICU)

Time: From baseline to day 29

Measure: Mortality rate

Time: From baseline to day 29

Description: Measured with artificial intelligence and expressed as cc and percent values of diseased lung (lung consolidation, ground glass opacities and disease free)

Measure: Changes from baseline in pulmonary computed tomography (CT) imaging severity score

Time: Baseline, day 21; extra follow up at 90 days

Measure: Duration of hospital stay expressed in days

Time: From baseline to day 29

Measure: Viral load measured on plasma with RT-PCR

Time: 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)

Time: Baseline, day 15

Measure: Antibodies to SARS-CoV-2

Time: Baseline, days 7, 15, 29

Measure: Antibodies to IFN-β1a

Time: Baseline, days 7, 15, 29


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