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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Covid19

Intervention / Treatment
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* Drug: GX-I7
* Drug: GX-I7 vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GX-I7<br>GX-I7 | Drug: GX-I7<br>* Recombinant human interleukin-7 hybrid Fc<br>* Other names: TJ107;|
| Placebo Comparator: GX-I7 vehicle<br>GX-I7 vehicle | Drug: GX-I7 vehicle<br>* Formulation buffer of recombinant human interleukin-7 hybrid Fc<br>|

What is the study measuring?
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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 |