Safety and Preliminary Efficacy Study of GX-I7 in Patients With COVID-19

Phase 1TerminatedNCT04730427

Genexine, Inc.10 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Covid19

Interventions

GX-I7DRUG

Recombinant human interleukin-7 hybrid Fc

GX-I7 vehicleDRUG

Formulation buffer of recombinant human interleukin-7 hybrid Fc

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Borame Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: up to 52 weeks

Shift from baseline of hematology

The number of patients in hematology shifted from normal or abnormal (NCS) to abnormal (CS)

Time frame: 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)

Time frame: up to 52 weeks

Dose limiting toxicity (DLT)

The incident rate of DLT

Time frame: up to 52 weeks

Secondary Outcomes

Absolute lymphocyte count (ALC)

The change of absolute lymphocyte count from baseline

Time frame: up to 3 weeks

RT-PCR for COVID-19

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

Data from ClinicalTrials.gov

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