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

Phase 1

Terminated

• Conditions: Covid19
• Interventions: Drug: GX-I7 vehicle; Drug: GX-I7

• Registration Number: NCT04730427
• Lead Sponsor: Genexine, Inc.

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-01-27
• Study First Posted: 2021-01-29
• Study Start: 2021-03-24
• Status Verified: 2022-03
• Primary Completion: 2022-05-08
• Study Completion: 2022-07-07
• Last Update Submitted: 2022-11-25
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GX-I7 vehicle	GX-I7 vehicle	GX-I7 vehicle
GX-I7	GX-I7	GX-I7

Primary Outcome Measures

Name	Time	Method
Incidence rate, characteristics, and severity of adverse reactions	up to 52 weeks	To evaluate the safety of GX-I7 in patients with COVID-19 (rating according to NCI CTCAE v5.0)
Shift from baseline of physical examination	up to 52 weeks	The number of patients in physical examination shifted from normal or abnormal (NCS) to abnormal (CS)
Dose limiting toxicity (DLT)	up to 52 weeks	The incident rate of DLT
Shift from baseline of blood chemistry	up to 52 weeks	The number of patients in blood chemistry shifted from normal or abnormal (NCS) to abnormal (CS)
Shift from baseline of hematology	up to 52 weeks	The number of patients in hematology shifted from normal or abnormal (NCS) to abnormal (CS)
Shift from baseline of vital sign	up to 52 weeks	The number of patients in vital sign shifted from normal or abnormal (NCS) to abnormal (CS)

Secondary Outcome Measures

Name	Time	Method
RT-PCR for COVID-19	up to 52 weeks	To evaluate the efficacy of GX-I7 in patients with COVID-19
Absolute lymphocyte count (ALC)	up to 3 weeks	The change of absolute lymphocyte count from baseline
Assessment of clinical improvement by modified early warning score (MEWS)	up to 52 weeks	Changes of modified early warning score (MEWS) from the baseline after the IP administration \[Low-risk (score 0) \~ high-risk (score 3)\]
Ordinal scale for clinical improvement (WHO) in each visit	up to 52 weeks	Changes of ordinal scale for clinical improvement (WHO) from the baseline after the IP administration \[Uninfected 0 \~ Dead 8\]
The proportion of subjects who have progressed to death or a critical illness	up to 52 weeks	To evaluate the efficacy of GX-I7 in patients with COVID-19
Immune repertoire	up to 52 weeks	Changes in the rate of different immune cell types and regulatory T cell in the blood after the IP administration

Trial Locations

Locations (1)

Borame Medical Center; 🇰🇷 Seoul, Korea, Republic of