Name (Synonyms) | Correlation |
---|
There is one clinical trial.
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.
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 29Description: 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, 29Description: 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, 29Description: 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