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Virus Therapy
Active plus SOC for Coronavirus (NOVATION-1 Trial)
Phase 3
Recruiting
Research Sponsored by Genova Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose to day 56
Awards & highlights
NOVATION-1 Trial 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
Eligible Conditions
- Coronavirus
NOVATION-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose to day 56
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose to day 56
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of clinical deterioration
Secondary outcome measures
Adverse events
Duration of hospitalization
Hospital discharge rate
+2 moreNOVATION-1 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active plus SOCExperimental Treatment1 Intervention
Inhaled Novaferon, given 20 ug BID, daily for 10 days, plus Standard of Care
Group II: Placebo plus SOCPlacebo Group1 Intervention
Inhaled vehicle formulation (placebo), given BID, daily for 10 days, plus Standard of Care
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Who is running the clinical trial?
Genova Inc.Lead Sponsor
2 Previous Clinical Trials
607 Total Patients Enrolled
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