MedTrace Logo

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

NCT04669015 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 914

Last updated 2022-06-03

No results posted yet for this study

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

BIOLOGICAL

Novaferon

a novel recombinant antiviral protein drug

BIOLOGICAL

Placebo

Formulation vehicle

Sponsors & Collaborators

  • Genova Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-10
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • Argentina
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Indonesia
  • Kenya
  • Malaysia
  • Peru
  • South Africa
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04669015 on ClinicalTrials.gov