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, 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

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Drug: GX-I7

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 Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Paritosh Keertikar, PhD; Phone Number: +65 9730 6164; Email: paritosh.keertikar@innogene.com.sg
• Study Contact Backup: Name: Artati A, MBBS; Phone Number: +62 812-9262-727; Email: artati@kalbe.co.id

Study Locations

• Indonesia
  • Jakarta Pusat, Indonesia
    • Recruiting
    • Mitra Keluarga Kelapa Gading
    • Contact: Dr. Frans Liwang, SpPD
  • Jakarta Pusat, Indonesia
    • Recruiting
    • Mitra Keluarga Kemayoran
    • Contact: Dr Candra Wibowo, SpPD-KGH FINASIM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adults aged 50 years and above at the time of consent
2. 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.
3. Patients who provide a voluntarily consent to participate in the study and sign the consent form in his/her own handwriting.
4. 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.
5. 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
6. Patients who agree for the hospitalisation (however, the hospitalisation will be performed only if needed)

Exclusion Criteria:

1. Patients who are unable to follow clinical and follow-up procedures
2. 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)
3. Patients who have clinically significant cardiovascular diseases such as myocardial infarction, unstable arrhythmia and/or unstable angina within 3 months
4. 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)
5. 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
6. Patients who are known to be HIV positive
7. Patients who are known to be B-type, or C-type hepatitis-positive carrier
8. Patients who are pregnant or breastfeeding
9. Patients suspected of or identified with a malignant tumor or have a history of tumors within the past 5 years
10. Patients with the infectious diseases such as bacteremia or severe pneumonia requiring active treatment within four weeks prior to the IP administration
11. Patients with immunodeficiency or autoimmune diseases that can be exacerbated through immunotherapy at present
12. Patients who have previously received an allogeneic marrow transplantation or solid organ transplantation
13. Patients who are currently taking other drugs such as immunosuppressants that may affect the results of the study
14. Patients who have severe allergy for humanized antibodies or fusion proteins, anaphylaxis, or other hypersensitivity
15. 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) -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GX-I7; Patients randomised on experimental arm will receive GX-I7 drug	Drug: GX-I7; Recombinant human interleukin-7 hybrid Fc; Other Names: rhIL-7-hyFc; NT-I7; TJ107; Efineptakin alfa NT-I7
Placebo Comparator: GX-I7 vehicle; Patients randomised on comparator arm will receive placebo	Drug: GX-I7; Recombinant human interleukin-7 hybrid Fc; Other Names: rhIL-7-hyFc; NT-I7; TJ107; Efineptakin alfa NT-I7

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose finding	MTD and RP2D based on safety profiles	9 weeks
Absolute lymphocyte count (ALC)	The change of absolute lymphocyte count from baseline	9 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment related Adverse Events	The proportion of participants with treatment emergent adverse events	10 weeks
Status of COVID-19 infection	Decrease of viral shedding identified with nasopharyngeal swab specimen by RT-PCR test	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	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)	9 weeks
Assess in improvement in clinical parameters	Time to ≥ 1-point improvement (days) from Day 1 (baseline) in terms of clinical status	9 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune repertoire in the study population	Changes of the rate of different immune cell types (i.e, effector/ memory T cell) and regulatory T cell (i.e, Tregs) in the blood after a single efineptakin alfa treatment, if possible	9 weeks

Collaborators and Investigators

• Sponsor: PT Kalbe Genexine Biologics
• Collaborators: Genexine, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 22, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: GXI7KGBio-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No