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

Covid19 Clinical Trial

Official title:

A Phase 1b Study to Investigate the Safety and Preliminary Efficacy of GX-I7 in Patients With COVID-19

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04730427
• Other study ID #: GX-I7-COV-009
• Status: Terminated
• Phase: Phase 1
• Start date: March 24, 2021
• Est. completion date: July 7, 2022

Study information

• Verified date: March 2022
• Source: Genexine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: July 7, 2022
• Est. primary completion date: May 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• GX-I7
Recombinant human interleukin-7 hybrid Fc
• GX-I7 vehicle
Formulation buffer of recombinant human interleukin-7 hybrid Fc

Locations

Country	Name	City	State
Korea, Republic of	Borame Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Genexine, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	up to 52 weeks
Primary	Shift from baseline of vital sign	The number of patients in vital sign shifted from normal or abnormal (NCS) to abnormal (CS)	up to 52 weeks
Primary	Shift from baseline of physical examination	The number of patients in physical examination shifted from normal or abnormal (NCS) to abnormal (CS)	up to 52 weeks
Primary	Shift from baseline of hematology	The number of patients in hematology shifted from normal or abnormal (NCS) to abnormal (CS)	up to 52 weeks
Primary	Shift from baseline of blood chemistry	The number of patients in blood chemistry shifted from normal or abnormal (NCS) to abnormal (CS)	up to 52 weeks
Primary	Dose limiting toxicity (DLT)	The incident rate of DLT	up to 52 weeks
Secondary	Absolute lymphocyte count (ALC)	The change of absolute lymphocyte count from baseline	up to 3 weeks
Secondary	RT-PCR for COVID-19	To evaluate the efficacy of GX-I7 in patients with COVID-19	up to 52 weeks
Secondary	Assessment of clinical improvement by modified early warning score (MEWS)	Changes of modified early warning score (MEWS) from the baseline after the IP administration [Low-risk (score 0) ~ high-risk (score 3)]	up to 52 weeks
Secondary	Ordinal scale for clinical improvement (WHO) in each visit	Changes of ordinal scale for clinical improvement (WHO) from the baseline after the IP administration [Uninfected 0 ~ Dead 8]	up to 52 weeks
Secondary	The proportion of subjects who have progressed to death or a critical illness	To evaluate the efficacy of GX-I7 in patients with COVID-19	up to 52 weeks
Secondary	Immune repertoire	Changes in the rate of different immune cell types and regulatory T cell in the blood after the IP administration	up to 52 weeks