Covid19Phase 2NCT04810637
A Study to Evaluate the Safety and Efficacy of GX-I7 in Elderly Patients With Asymptomatic or Mild Symptoms of COVID-19
A Phase 2 study testing GX-I7 in people with Covid19, run by PT Kalbe Genexine Biologics at 2 sites in Indonesia.
Trial summary
This is a Phase 2 prospective, randomized, placebo-controlled, double-blinded, parallel group, single administration, multi-center study to assess the safety and efficacy of efineptakin alfa single treatment compared to placebo in elderly participants (adults ≥50years) with asymptomatic or mild COVID-19 Read more about this study
- Who is it for?
- Ages 50 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
- 210 participants
- Where
- 2 sitesIndonesia
- Study dates
- 1 Nov 2020to Sep 2021
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 50 years and above at the time of consent
- Subjects who have been confirmed to be COVID-19 corresponding to asymptomatic case or mild cases of severity categorization classified by FDA through authorized molecular saliva-based test or polymerase chain reaction (PCR) test and who can be available to be administered within 7 days from the onset of any symptoms.
- Patients who provide a voluntarily consent to participate in the study and sign the consent form in his/her own handwriting.
- Female patients of childbearing potential (including female received a tubal ligation) should be prove negative pregnancy through pregnancy test before 24 hours of the IP administration, and must be willing to maintain abstinence (restraint sexual relationships) or use an adequate method of contraception at least 90 days after the IP administration.
- Male patients must be willing to maintain abstinence (restraint sexual relationships) or use of adequate contraception method, and not to donate sperm. Men with childbearing or pregnant female spouses should maintain abstinence or use condoms at least 90 days after the IP administration to avoid exposure to embryos
- Patients who agree for the hospitalisation (however, the hospitalisation will be performed only if needed)
Who cannot join
- Patients who are unable to follow clinical and follow-up procedures
- 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)
- Patients who have clinically significant cardiovascular diseases such as myocardial infarction, unstable arrhythmia and/or unstable angina within 3 months
- Patients who have uncontrolled type II diabetes mellitus (despite the proper use of the drug, if fasting blood sugar level is not controlled to be more than 200 mg/dL)
- If the principal investigator determines that patients are ineligible or difficult to follow the protocol due to evidence of severe or unregulated systemic diseases, uncontrolled hypertension (despite the proper use of the drug, if the blood pressure is not controlled to be lower than 150/90 mmHg), and active bleeding tendency
- Patients who are known to be HIV positive
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- Patients who are known to be B-type, or C-type hepatitis-positive carrier
- Patients who are pregnant or breastfeeding
- Patients suspected of or identified with a malignant tumor or have a history of tumors within the past 5 years
- Patients with the infectious diseases such as bacteremia or severe pneumonia requiring active treatment within four weeks prior to the IP administration
- Patients with immunodeficiency or autoimmune diseases that can be exacerbated through immunotherapy at present
- Patients who have previously received an allogeneic marrow transplantation or solid organ transplantation
- Patients who are currently taking other drugs such as immunosuppressants that may affect the results of the study
- Patients who have severe allergy for humanized antibodies or fusion proteins, anaphylaxis, or other hypersensitivity
- Patients who have received other IP administration while participating in another clinical trial within 30 days prior to the IP administration for this study (However, biological preparation shall be applied to 60 days and even longer period can be applied considering the half-life) -
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites, 2 recruiting
- Recruiting
Mitra Keluarga Kelapa Gading
Jakarta Pusat
Dr. Frans Liwang, SpPD
- Recruiting
Mitra Keluarga Kemayoran
Jakarta Pusat
Dr Candra Wibowo, SpPD-KGH FINASIM
About this study
Official title: A Phase 2, Randomized, Double Blinded, Placebo Controlled, Parallel Group, Single Administration Study to Evaluate the Safety and Efficacy of GX-I7 in Elderly Patients With Asymptomatic or Mild Symptoms of COVID-19
This is a Phase 2 prospective, randomized, placebo-controlled, double-blinded, parallel group, single administration, multi-center study to assess the safety and efficacy of efineptakin alfa single treatment compared to placebo in elderly participants (adults ≥50years) with asymptomatic or mild COVID-19
Read the detailed description
The study consists of 2 parts:
Part I - to identify the Recommended Phase 2 Dose (RP2D) compared to placebo in elderly participants (adults ≥50 years) with asymptomatic or mild COVID-19. These patients will be treated with 120 and 240 µg/kg efineptakin alfa, given on Day 1 (Baseline), respectively. The study will evaluate the safety, tolerability, and pharmacodynamics variable (ALC) of efineptakin alfa against COVID-19.
Part II - to assess the safety and efficacy of efineptakin alfa single treatment compared to placebo in elderly participants with asymptomatic or mild COVID-19.
- Conditions
- Covid19
- Being tested
- GX-I7
- 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 NT-I7, rhIL-7-hyFc, NT-I7, TJ107
Recombinant human interleukin-7 hybrid Fc
| Study group | Role | What they receive |
|---|---|---|
| GX-I7 | Experimental | Patients randomised on experimental arm will receive GX-I7 drug Receives: Drug: GX-I7 |
| GX-I7 vehicle | Placebo comparator | Patients randomised on comparator arm will receive placebo Receives: Drug: GX-I7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose finding
MTD and RP2D based on safety profiles
Measured: 9 weeks
Absolute lymphocyte count (ALC)
The change of absolute lymphocyte count from baseline
Measured: 9 weeks
Secondary outcomes (5)
Treatment related Adverse Events
The proportion of participants with treatment emergent adverse events
Measured: 10 weeks
Status of COVID-19 infection
Decrease of viral shedding identified with nasopharyngeal swab specimen by RT-PCR test
Measured: 9 weeks
To evaluate the efficacy of GX-I7 in patients with COVID-19
The proportion of participants who have progressed to moderate or severe or critical illness
Measured: 9 weeks
Improvement in clinical parameters
Time to clinical improvement: clinical improvement is defined as a ≥ 2-point improvement in clinical status (8-point ordinal scale) from Day 1 (baseline)
Measured: 9 weeks
Assess in improvement in clinical parameters
Time to ≥ 1-point improvement (days) from Day 1 (baseline) in terms of clinical status
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Nov 2020
- Primary completionJun 2021 (estimated)
- Study completionSep 2021 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded phase 2 controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PT Kalbe Genexine Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genexine, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810637
- Sponsor's protocol ID
- GXI7KGBio-001
- Status last verified
- Mar 2021
- First submitted
- 17 Mar 2021
- Last updated
- 24 Mar 2021
- 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 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double Blinded, Placebo Controlled, Parallel Group, Single Administration Study to Evaluate the Safety and Efficacy of GX-I7 in Elderly Patients With Asymptomatic or Mild Symptoms of COVID-19
- ClinicalTrials.gov ID
- NCT04810637
- Acronym / sponsor ID
- GXI7KGBio-001
- Conditions
- Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- PT Kalbe Genexine BiologicsIndustry (pharma, biotech, devices)
- Collaborators
- Genexine, Inc.
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 23 Mar 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 is a Phase 2 prospective, randomized, placebo-controlled, double-blinded, parallel group, single administration, multi-center study to assess the safety and efficacy of efineptakin alfa single treatment compared to placebo in elderly participants (adults ≥50years) with asymptomatic or mild COVID-19
Detailed description
The study consists of 2 parts:
Part I - to identify the Recommended Phase 2 Dose (RP2D) compared to placebo in elderly participants (adults ≥50 years) with asymptomatic or mild COVID-19. These patients will be treated with 120 and 240 µg/kg efineptakin alfa, given on Day 1 (Baseline), respectively. The study will evaluate the safety, tolerability, and pharmacodynamics variable (ALC) of efineptakin alfa against COVID-19.
Part II - to assess the safety and efficacy of efineptakin alfa single treatment compared to placebo in elderly participants with asymptomatic or mild COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double blinded phase 2 controlled study
| Arm | Type | Receives |
|---|---|---|
| GX-I7 | Experimental | Drug: GX-I7Patients randomised on experimental arm will receive GX-I7 drug |
| GX-I7 vehicle | Placebo comparator | Drug: GX-I7Patients randomised on comparator arm will receive placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 50 years and above at the time of consent
- Subjects who have been confirmed to be COVID-19 corresponding to asymptomatic case or mild cases of severity categorization classified by FDA through authorized molecular saliva-based test or polymerase chain reaction (PCR) test and who can be available to be administered within 7 days from the onset of any symptoms.
- Patients who provide a voluntarily consent to participate in the study and sign the consent form in his/her own handwriting.
- Female patients of childbearing potential (including female received a tubal ligation) should be prove negative pregnancy through pregnancy test before 24 hours of the IP administration, and must be willing to maintain abstinence (restraint sexual relationships) or use an adequate method of contraception at least 90 days after the IP administration.
- Male patients must be willing to maintain abstinence (restraint sexual relationships) or use of adequate contraception method, and not to donate sperm. Men with childbearing or pregnant female spouses should maintain abstinence or use condoms at least 90 days after the IP administration to avoid exposure to embryos
Key exclusion criteria (15 listed)
- Patients who are unable to follow clinical and follow-up procedures
- 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)
- Patients who have clinically significant cardiovascular diseases such as myocardial infarction, unstable arrhythmia and/or unstable angina within 3 months
- Patients who have uncontrolled type II diabetes mellitus (despite the proper use of the drug, if fasting blood sugar level is not controlled to be more than 200 mg/dL)
- If the principal investigator determines that patients are ineligible or difficult to follow the protocol due to evidence of severe or unregulated systemic diseases, uncontrolled hypertension (despite the proper use of the drug, if the blood pressure is not controlled to be lower than 150/90 mmHg), and active bleeding tendency
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 NT-I7, rhIL-7-hyFc, NT-I7, TJ107Recombinant human interleukin-7 hybrid Fc | Drug | GX-I7, GX-I7 vehicle |
Primary outcome
Dose finding
Time frame: 9 weeks
MTD and RP2D based on safety profiles
Absolute lymphocyte count (ALC)
Time frame: 9 weeks
The change of absolute lymphocyte count from baseline
5 secondary outcomes
Treatment related Adverse Events
Time frame: 10 weeks
Status of COVID-19 infection
Time frame: 9 weeks
To evaluate the efficacy of GX-I7 in patients with COVID-19
Time frame: 9 weeks
Improvement in clinical parameters
Time frame: 9 weeks
Assess in improvement in clinical parameters
Time frame: 9 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GX-I7 in people with Covid19, run by PT Kalbe Genexine Biologics at 2 sites in Indonesia.
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 6 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paritosh Keertikar, PhD (+65 9730 6164, paritosh.keertikar@innogene.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose finding (time frame: 9 weeks). The study lists 2 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 24 Mar 2021.