A Phase 1 interventional study of GX-I7 and GX-I7 vehicle in Covid19, sponsored by Genexine, Inc.. Terminated at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-11-30.
Sponsored by Genexine, Inc. · Phase 1, Interventional, and Treatment
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
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 10 is below the median of 100 across 4,098 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Genexine, Inc. is the lead sponsor of 35 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
GX-I7
Drug: GX-I7
GX-I7 vehicle
Drug: GX-I7 vehicle
Recombinant human interleukin-7 hybrid Fc
Also known as: Efineptakin alfa, rhIL-7-hyFc, NT-I7, TJ107
Formulation buffer of recombinant human interleukin-7 hybrid Fc
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)
Time frame: 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)
Time frame: 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)
Time frame: up to 52 weeks
Shift from baseline of hematology
The number of patients in hematology shifted from normal or abnormal (NCS) to abnormal (CS)
Time frame: 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)
Time frame: up to 52 weeks
Dose limiting toxicity (DLT)
The incident rate of DLT
Time frame: up to 52 weeks
Absolute lymphocyte count (ALC)
The change of absolute lymphocyte count from baseline
Time frame: up to 3 weeks
RT-PCR for COVID-19
To evaluate the efficacy of GX-I7 in patients with COVID-19
Time frame: 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 \[Low-risk (score 0) \~ high-risk (score 3)\]
Time frame: 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 \[Uninfected 0 \~ Dead 8\]
Time frame: 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
Time frame: 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
Time frame: up to 52 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Genexine, Inc.