Clincosm LogoSign in Get a demo

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

Sponsor
Genexine, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04730427
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
13.2
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Single blind
Primary Purpose:
Treatment
Official Title:
A Phase 1b Study to Investigate the Safety and Preliminary Efficacy of GX-I7 in Patients With COVID-19
Actual Study Start Date :
Mar 24, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: GX-I7

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

    GX-I7 vehicle

    Drug: GX-I7 vehicle
    Formulation buffer of recombinant human interleukin-7 hybrid Fc

    Outcome Measures

    Primary Outcome Measures

    1. Incidence rate, characteristics, and severity of adverse reactions [up to 52 weeks]

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

    2. Shift from baseline of vital sign [up to 52 weeks]

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

    3. Shift from baseline of physical examination [up to 52 weeks]

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

    4. Shift from baseline of hematology [up to 52 weeks]

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

    5. Shift from baseline of blood chemistry [up to 52 weeks]

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

    6. Dose limiting toxicity (DLT) [up to 52 weeks]

      The incident rate of DLT

    Secondary Outcome Measures

    1. Absolute lymphocyte count (ALC) [up to 3 weeks]

      The change of absolute lymphocyte count from baseline

    2. RT-PCR for COVID-19 [up to 52 weeks]

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

    3. Assessment of clinical improvement by modified early warning score (MEWS) [up to 52 weeks]

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

    4. Ordinal scale for clinical improvement (WHO) in each visit [up to 52 weeks]

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

    5. The proportion of subjects who have progressed to death or a critical illness [up to 52 weeks]

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

    6. Immune repertoire [up to 52 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Borame Medical Center Seoul Korea, Republic of 07061

    Sponsors and Collaborators

    • Genexine, Inc.

    Investigators

    • Study Director: Minkyu Heo, Genexine_Clinical Development Dept.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Genexine, Inc.
    ClinicalTrials.gov Identifier:
    NCT04730427
    Other Study ID Numbers:
    • GX-I7-COV-009
    First Posted:
    Jan 29, 2021
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Mar 4, 2022