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

A Phase 1b Study to Investigate the Safety and Preliminary Efficacy of GX-I7 in Patients With COVID-19

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.

Study Overview

• Status: Terminated
• Conditions: Covid19
• Intervention / Treatment: Drug: GX-I7; Drug: GX-I7 vehicle

Detailed Description

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.

Study design: prospective, randomized, placebo-controlled, single-blind, single-center

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 07061
    • Borame Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

1. 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.
2. Subjects who are or will be inpatient.

Key Exclusion Criteria:

1. 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)
2. Subjects with infectious diseases such as bacteremia or severe pneumonia requiring active treatment within four weeks prior to the IP administration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GX-I7	Drug: GX-I7; Recombinant human interleukin-7 hybrid Fc; Other Names: Efineptakin alfa; rhIL-7-hyFc; NT-I7; TJ107
Placebo Comparator: GX-I7 vehicle	Drug: GX-I7 vehicle; Formulation buffer of recombinant human interleukin-7 hybrid Fc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute lymphocyte count (ALC)	The change of absolute lymphocyte count from baseline	up to 3 weeks
RT-PCR for COVID-19	To evaluate the efficacy of GX-I7 in patients with COVID-19	up to 52 weeks
Assessment of clinical improvement by modified early warning score (MEWS)	Changes of modified early warning score (MEWS) from the baseline after the IP administration [Low-risk (score 0) ~ high-risk (score 3)]	up to 52 weeks
Ordinal scale for clinical improvement (WHO) in each visit	Changes of ordinal scale for clinical improvement (WHO) from the baseline after the IP administration [Uninfected 0 ~ Dead 8]	up to 52 weeks
The proportion of subjects who have progressed to death or a critical illness	To evaluate the efficacy of GX-I7 in patients with COVID-19	up to 52 weeks
Immune repertoire	Changes in the rate of different immune cell types and regulatory T cell in the blood after the IP administration	up to 52 weeks

Collaborators and Investigators

• Sponsor: Genexine, Inc.
• Investigators: Study Director: Minkyu Heo, Genexine_Clinical Development Dept.

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2021
• Primary Completion (Actual): May 8, 2022
• Study Completion (Actual): July 7, 2022

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 25, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: GX-I7-COV-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No