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Sponsor's decision
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GX-I7 | Experimental | GX-I7 |
|
| GX-I7 vehicle | Placebo Comparator | GX-I7 vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GX-I7 | Drug | Recombinant human interleukin-7 hybrid Fc |
|
|
| 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 |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Minkyu Heo | Genexine_Clinical Development Dept. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Borame Medical Center | Seoul | 07061 | South Korea |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000712767 | efineptakin alfa |
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Single blind
| GX-I7 vehicle | Drug | Formulation buffer of recombinant human interleukin-7 hybrid Fc |
|
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |