Covid19
Conditions
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
Interventions
DRUGGX-I7
Recombinant human interleukin-7 hybrid Fc
DRUGGX-I7 vehicle
Formulation buffer of recombinant human interleukin-7 hybrid Fc
Sponsors
Genexine, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single blind
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose limiting toxicity (DLT) | up to 52 weeks | The incident rate of DLT |
| 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) |
| 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) |
| 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) |
| Shift from baseline of hematology | up to 52 weeks | The number of patients in hematology shifted from normal or abnormal (NCS) to abnormal (CS) |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute lymphocyte count (ALC) | up to 3 weeks | The change of absolute lymphocyte count from baseline |
| RT-PCR for COVID-19 | up to 52 weeks | To evaluate the efficacy of GX-I7 in patients with COVID-19 |
| 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 \[Low-risk (score 0) \ high-risk (score 3)\] |
| 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 \[Uninfected 0 \ Dead 8\] |
| 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 |
| 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 |
Countries
South Korea
Outcome results
None listed