This double-blinded, randomized study is being conducted to see if the investigational new drug called FP-1201-lyo - intravenous Interferon beta-1a, hereafter IV IFN beta-1a, can help patients recover more quickly from COVID-19 and prevent worsening of the condition. To understand if IV IFN beta-1a can help treat patients with COVID-19, this study drug will be compared to dexamethasone. Study subjects will be treated daily with IV IFN beta-1a 10 μg or IV dexamethasone for 6 consecutive days while hospitalized and will undergo daily assessments while in hospital for a maximum of 28 days. Study specific assessments will be collected at pre-dose Day 1 through Day 28 (PD and PIM assessments), in addition, clinical routine assessments will be utilized for safety and efficacy assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
7
Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised
Treated daily with dexamethasone 6 mg as an IV bolus for 6 days while hospitalised
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Newton-Wellesley Hospital
Newton, Massachusetts, United States
Vanderbilt University School of Medicine
Nashville, Tennessee, United States
Clinical Status at Day 14 (First Day of Study Drug is Day 1) as Measured by WHO 9-point Ordinal Scale
WHO 9-point ordinal scale: 0 - No detectable infection 1. \- Not hospitalized, no limitations on activities 2. \- Not hospitalized, limitation on activities 3. \- Hospitalized, not requiring supplemental oxygen 4. \- Hospitalized, requiring supplemental oxygen 5. \- Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. \- Hospitalized, on invasive mechanical ventilation 7. \- Hospitalized, on mechanical ventilation plus additional organ support: renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO) 8. \- Death
Time frame: Day 14
In-hospital Mortality at Day 28 and Day 90
Percentage of participants per study group that die when in still hospital at Day 28 or Day 90 of the trial
Time frame: Day 28 and Day 90
Overall (All-cause) Mortality at Day 28 and Day 90
Percentage of participants per study group that die within 28 days or 90 days from starting the study
Time frame: Day 28 and Day 90
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