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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-24

Study Completion Date

2022-07-07

Brief Summary

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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.

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Detailed Description

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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

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Single blind

Study Groups

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GX-I7

Group Type EXPERIMENTAL

GX-I7

Intervention Type DRUG

Recombinant human interleukin-7 hybrid Fc

GX-I7 vehicle

Group Type PLACEBO_COMPARATOR

GX-I7 vehicle

Intervention Type DRUG

Formulation buffer of recombinant human interleukin-7 hybrid Fc

Interventions

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GX-I7

Recombinant human interleukin-7 hybrid Fc

Intervention Type DRUG

GX-I7 vehicle

Formulation buffer of recombinant human interleukin-7 hybrid Fc

Intervention Type DRUG

Other Intervention Names

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Efineptakin alfa rhIL-7-hyFc NT-I7 TJ107

Eligibility Criteria

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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.

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No