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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
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
Any pharmacological (e.g. antibiotics, etc.) and non-pharmacological (e.g. oxygen, ventilation, etc.) treatments prescribed on clinical grounds
IRCCS Ospedale San Raffaele
Milan, Italy
Time to negative conversion of SARS-CoV-2 nasopharyngeal swab
Viral load will be measured by Real Time-Polymerase Chain Reaction (RT-PCR)
Time frame: From baseline to day 29
Improvement in clinical severity score (a)
Defined as percentage of patients reporting each severity rating on a 7-point ordinal scale
Time frame: Baseline, days 7, 15, 21, 29
Improvement in clinical severity score (b)
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
Time frame: Baseline, days 7, 15, 21, 29
Incidence of new oxygen use, non-invasive ventilation, or high flow oxygen devices during the trial
Time frame: From baseline to day 29
Oxygenation free days in the first 28 days
Time frame: From baseline to day 29
Ventilator free days in the first 28 days
Time frame: From baseline to day 29
Incidence of new mechanical ventilation use during the trial
Time frame: From baseline to day 29
Number of patients transferred to Intensive Care Unit (ICU)
Time frame: From baseline to day 29
Mortality rate
Time frame: From baseline to day 29
Changes from baseline in pulmonary computed tomography (CT) imaging severity score
Measured with artificial intelligence and expressed as cc and percent values of diseased lung (lung consolidation, ground glass opacities and disease free)
Time frame: Baseline, day 21; extra follow up at 90 days
Duration of hospital stay expressed in days
Time frame: From baseline to day 29
Viral load measured on plasma with RT-PCR
Time frame: Baseline, days 3, 5, 7, 9, 11, 13, 15, 21, 29
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.