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

Primary Purpose

Covid19

Status

Terminated

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

GX-I7

GX-I7 vehicle

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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

Sites / Locations

Borame Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GX-I7

GX-I7 vehicle

Arm Description

GX-I7

GX-I7 vehicle

Outcomes

Primary Outcome Measures

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)

Shift from baseline of vital sign

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

Shift from baseline of physical examination

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

Shift from baseline of hematology

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

Shift from baseline of blood chemistry

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

Dose limiting toxicity (DLT)

The incident rate of DLT

Secondary Outcome Measures

Absolute lymphocyte count (ALC)

The change of absolute lymphocyte count from baseline

RT-PCR for COVID-19

To evaluate the efficacy of GX-I7 in patients with COVID-19

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)]

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]

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

Immune repertoire

Changes in the rate of different immune cell types and regulatory T cell in the blood after the IP administration

Full Information

NCT ID

NCT04730427

First Posted

January 20, 2021

Last Updated

November 25, 2022

Sponsor

Genexine, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04730427

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Terminated

Why Stopped

Sponsor's decision

Study Start Date

March 24, 2021 (Actual)

Primary Completion Date

May 8, 2022 (Actual)

Study Completion Date

July 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genexine, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Masking Description

Single blind

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GX-I7

Arm Type

Experimental

Arm Description

GX-I7

Arm Title

GX-I7 vehicle

Arm Type

Placebo Comparator

Arm Description

GX-I7 vehicle

Intervention Type

Drug

Intervention Name(s)

GX-I7

Other Intervention Name(s)

Efineptakin alfa, rhIL-7-hyFc, NT-I7, TJ107

Intervention Description

Recombinant human interleukin-7 hybrid Fc

Intervention Type

Drug

Intervention Name(s)

GX-I7 vehicle

Intervention Description

Formulation buffer of recombinant human interleukin-7 hybrid Fc

Primary Outcome Measure Information:

Title

Incidence rate, characteristics, and severity of adverse reactions

Description

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

Time Frame

up to 52 weeks

Title

Shift from baseline of vital sign

Description

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

Time Frame

up to 52 weeks

Title

Shift from baseline of physical examination

Description

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

Time Frame

up to 52 weeks

Title

Shift from baseline of hematology

Description

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

Time Frame

up to 52 weeks

Title

Shift from baseline of blood chemistry

Description

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

Time Frame

up to 52 weeks

Title

Dose limiting toxicity (DLT)

Description

The incident rate of DLT

Time Frame

up to 52 weeks

Secondary Outcome Measure Information:

Title

Absolute lymphocyte count (ALC)

Description

The change of absolute lymphocyte count from baseline

Time Frame

up to 3 weeks

Title

RT-PCR for COVID-19

Description

To evaluate the efficacy of GX-I7 in patients with COVID-19

Time Frame

up to 52 weeks

Title

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

Description

Changes of modified early warning score (MEWS) from the baseline after the IP administration [Low-risk (score 0) ~ high-risk (score 3)]

Time Frame

up to 52 weeks

Title

Ordinal scale for clinical improvement (WHO) in each visit

Description

Changes of ordinal scale for clinical improvement (WHO) from the baseline after the IP administration [Uninfected 0 ~ Dead 8]

Time Frame

up to 52 weeks

Title

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

Description

To evaluate the efficacy of GX-I7 in patients with COVID-19

Time Frame

up to 52 weeks

Title

Immune repertoire

Description

Changes in the rate of different immune cell types and regulatory T cell in the blood after the IP administration

Time Frame

up to 52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: 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. Key Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Minkyu Heo

Organizational Affiliation

Genexine_Clinical Development Dept.

Official's Role

Study Director

Facility Information:

Facility Name

Borame Medical Center

City

Seoul

ZIP/Postal Code

07061

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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