A Study to Evaluate the Safety and Efficacy of GX-I7 in Elderly Patients With Asymptomatic or Mild Symptoms of COVID-19

NCT04810637 | Unknown Phase 2 DMC

• 1 other identifier: GXI7KGBio-001
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Treatment related Adverse Events

  10 weeks

• Status of COVID-19 infection

  9 weeks

• To evaluate the efficacy of GX-I7 in patients with COVID-19

  9 weeks

• Improvement in clinical parameters

  9 weeks

• Assess in improvement in clinical parameters

  9 weeks

Other Outcomes (1)

• Immune repertoire in the study population

  9 weeks

Study Arms (2)

GX-I7

EXPERIMENTAL

Patients randomised on experimental arm will receive GX-I7 drug

Drug: GX-I7

GX-I7 vehicle

PLACEBO COMPARATOR

Patients randomised on comparator arm will receive placebo

Drug: GX-I7

Interventions

GX-I7 DRUG

Recombinant human interleukin-7 hybrid Fc

Also known as: Efineptakin alfa NT-I7, rhIL-7-hyFc, NT-I7, TJ107

GX-I7; GX-I7 vehicle

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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) -

Sponsors & Collaborators

• PT Kalbe Genexine Biologics: lead
• Genexine, Inc.: collaborator

Study Sites (2)

Mitra Keluarga Kelapa Gading

Jakarta Pusat, Indonesia

RECRUITING

Mitra Keluarga Kemayoran

Jakarta Pusat, Indonesia

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

efineptakin alfa

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Paritosh Keertikar, PhD

CONTACT

+65 9730 6164; paritosh.keertikar@innogene.com.sg

Artati A, MBBS

CONTACT

+62 812-9262-727; artati@kalbe.co.id

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double blinded phase 2 controlled study

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 23, 2021
• Study Start: November 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)