NCT04669015

Phase 3 Inhaled Novaferon Study in Hospitalized Patients With Moderate to Severe COVID-19

NOVATION-1: A Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Evaluate the Safety and Efficacy of Aerosolized Novaferon + SOC vs. Placebo + SOC in Hospitalized Adult Patients With Moderate to Severe COVID-19

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 914 (estimated)
• Sponsor: Genova Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, double-blind, multicenter, placebo-controlled trial to evaluate the safety and efficacy of a novel therapeutic agent, Novaferon, in hospitalized adult patients diagnosed with COVID-19. The study is comprised of two cohorts: * Cohort A: This is a blinded safety lead-in comprising two arms. 40 patients will be randomized on a 1:1 basis to receive either Novaferon or matched placebo via a commercial nebulizer, plus Standard of Care (SOC) * Cohort B: This is the main portion of the study, which comprises two arms. Up to 874 patients will be randomized on a 1:1 basis to receive either Novaferon or matched placebo via a commercial nebulizer, plus SOC

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	Novaferon	a novel recombinant antiviral protein drug
BIOLOGICAL	Placebo	Formulation vehicle

Timeline

• Start date: 2021-06-10
• Primary completion: 2022-08-01
• Completion: 2022-08-01
• First posted: 2020-12-16
• Last updated: 2022-06-03

Locations

88 sites across 12 countries: Argentina, Brazil, Canada, Chile, Colombia, Indonesia, Kenya, Malaysia, Peru, South Africa, Turkey (Türkiye), Ukraine