Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With CoronavirUS
Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
Summary
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.