Safety and Preliminary Efficacy Study of GX-I7 in Patients With COVID-19

NCT04730427 | Terminated Phase 1 DMC

• 1 other identifier: GX-I7-COV-009
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a phase 1b clinical trial to investigate the safety and preliminary effects of a single dose of a test drug or placebo to the subjects who has diagnosed as COVID-19 infection.

Conditions

Covid19

Outcome Measures

Primary Outcomes (6)

• Incidence rate, characteristics, and severity of adverse reactions

  To evaluate the safety of GX-I7 in patients with COVID-19 (rating according to NCI CTCAE v5.0)

  up to 52 weeks

• Shift from baseline of vital sign

  The number of patients in vital sign shifted from normal or abnormal (NCS) to abnormal (CS)

  up to 52 weeks

• Shift from baseline of physical examination

  The number of patients in physical examination shifted from normal or abnormal (NCS) to abnormal (CS)

  up to 52 weeks

• Shift from baseline of hematology

  The number of patients in hematology shifted from normal or abnormal (NCS) to abnormal (CS)

  up to 52 weeks

• Shift from baseline of blood chemistry

  The number of patients in blood chemistry shifted from normal or abnormal (NCS) to abnormal (CS)

  up to 52 weeks

• Dose limiting toxicity (DLT)

  The incident rate of DLT

  up to 52 weeks

Secondary Outcomes (6)

• Absolute lymphocyte count (ALC)

  up to 3 weeks

• RT-PCR for COVID-19

  up to 52 weeks

• Assessment of clinical improvement by modified early warning score (MEWS)

  up to 52 weeks

• Ordinal scale for clinical improvement (WHO) in each visit

  up to 52 weeks

• The proportion of subjects who have progressed to death or a critical illness

  up to 52 weeks

Study Arms (2)

GX-I7

EXPERIMENTAL

GX-I7

Drug: GX-I7

GX-I7 vehicle

PLACEBO COMPARATOR

GX-I7 vehicle

Drug: GX-I7 vehicle

Interventions

GX-I7 DRUG

Recombinant human interleukin-7 hybrid Fc

Also known as: Efineptakin alfa, rhIL-7-hyFc, NT-I7, TJ107

GX-I7

GX-I7 vehicle DRUG

Formulation buffer of recombinant human interleukin-7 hybrid Fc

GX-I7 vehicle

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have been confirmed to be COVID-19 corresponding to mild cases of severity categorization classified by FDA through polymerase chain reaction (PCR) test or virus gene test (sequencing) and who can be available to be administered within seven days from the date of manifestation.
• Subjects who are or will be inpatient.

You may not qualify if:

• Patients with symptoms of moderate or higher in the severity classification presented by FDA have evidence of lower respiratory tract infection in their imaging findings or need supplemental oxygen therapy or mechanical respiration (ie, non-invasive ventilation, invasive mechanical ventilation, extracorporeal membrane oxygenation, etc)
• Subjects with infectious diseases such as bacteremia or severe pneumonia requiring active treatment within four weeks prior to the IP administration

Sponsors & Collaborators

• Genexine, Inc.: lead

Study Sites (1)

Borame Medical Center

Seoul, 07061, South Korea

Location

MeSH Terms

Conditions

COVID-19

Interventions

efineptakin alfa

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Minkyu Heo

  Genexine_Clinical Development Dept.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 29, 2021
• Study Start: March 24, 2021
• Primary Completion: May 8, 2022
• Study Completion: July 7, 2022
• Last Updated: November 30, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)