Covid19Phase 1NCT04730427
Safety and Preliminary Efficacy Study of GX-I7 in Patients With COVID-19
A Phase 1 study testing GX-I7 in people with Covid19, run by Genexine, Inc. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- GX-I7
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Mar 2021to 7 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b Study to Investigate the Safety and Preliminary Efficacy of GX-I7 in Patients With COVID-19
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.
Read the 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
- Conditions
- Covid19
- Being tested
- GX-I7, GX-I7 vehicle
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GX-I7Drug
Also called Efineptakin alfa, rhIL-7-hyFc, NT-I7, TJ107
Recombinant human interleukin-7 hybrid Fc
GX-I7 vehicleDrug
Formulation buffer of recombinant human interleukin-7 hybrid Fc
| Study group | Role | What they receive |
|---|---|---|
| GX-I7 | Experimental | GX-I7 Receives: Drug: GX-I7 |
| GX-I7 vehicle | Placebo comparator | GX-I7 vehicle Receives: Drug: GX-I7 vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: up to 52 weeks
Shift from baseline of hematology
The number of patients in hematology shifted from normal or abnormal (NCS) to abnormal (CS)
Measured: 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)
Measured: up to 52 weeks
Dose limiting toxicity (DLT)
The incident rate of DLT
Measured: up to 52 weeks
Secondary outcomes (6)
Absolute lymphocyte count (ALC)
The change of absolute lymphocyte count from baseline
Measured: up to 3 weeks
RT-PCR for COVID-19
To evaluate the efficacy of GX-I7 in patients with COVID-19
Measured: 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)]
Measured: 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]
Measured: 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
Measured: 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
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start24 Mar 2021
- Primary completion8 May 2022
- Study completion7 Jul 2022
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genexine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minkyu Heo, Study director, Genexine_Clinical Development Dept.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730427
- Sponsor's protocol ID
- GX-I7-COV-009
- Status last verified
- Mar 2022
- First submitted
- 20 Jan 2021
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study to Investigate the Safety and Preliminary Efficacy of GX-I7 in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04730427
- Acronym / sponsor ID
- GX-I7-COV-009
- Conditions
- Covid19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Genexine, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 8 May 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GX-I7 | Experimental | Drug: GX-I7GX-I7 |
| GX-I7 vehicle | Placebo comparator | Drug: GX-I7 vehicleGX-I7 vehicle |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GX-I7Also: Efineptakin alfa, rhIL-7-hyFc, NT-I7, TJ107Recombinant human interleukin-7 hybrid Fc | Drug | GX-I7 |
| GX-I7 vehicleFormulation buffer of recombinant human interleukin-7 hybrid Fc | Drug | GX-I7 vehicle |
Primary outcome
Incidence rate, characteristics, and severity of adverse reactions
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 52 weeks
The number of patients in blood chemistry shifted from normal or abnormal (NCS) to abnormal (CS)
Dose limiting toxicity (DLT)
Time frame: up to 52 weeks
The incident rate of DLT
6 secondary outcomes
Absolute lymphocyte count (ALC)
Time frame: up to 3 weeks
RT-PCR for COVID-19
Time frame: up to 52 weeks
Assessment of clinical improvement by modified early warning score (MEWS)
Time frame: up to 52 weeks
Ordinal scale for clinical improvement (WHO) in each visit
Time frame: up to 52 weeks
The proportion of subjects who have progressed to death or a critical illness
Time frame: up to 52 weeks
Immune repertoire
Time frame: up to 52 weeks
Results and safety
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minkyu Heo study director
Genexine_Clinical Development Dept.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GX-I7 in people with Covid19, run by Genexine, Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate, characteristics, and severity of adverse reactions (time frame: up to 52 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.