NCT04860518

Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19

A Phase II Multi-Center, Double-Blind, Randomized and Controlled Study of the Safety and Efficacy of Intravenous Recombinant Human Interferon Beta-1a in Comparison to Dexamethasone for the Treatment of Hospitalized Patients With COVID-19 Infection

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Faron Pharmaceuticals Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	IFN beta-1a	Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised
DRUG	Dexamethasone	Treated daily with dexamethasone 6 mg as an IV bolus for 6 days while hospitalised

Timeline

• Start date: 2021-08-23
• Primary completion: 2022-04-04
• Completion: 2022-04-04
• First posted: 2021-04-27
• Last updated: 2023-07-21
• Results posted: 2022-10-14

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study