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

Genexine

Status and phase

Terminated

Phase 1

Conditions

Covid19

Treatments

Drug: GX-I7

Drug: GX-I7 vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT04730427

GX-I7-COV-009

Details and patient eligibility

About

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.

Full 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

Enrollment

10 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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.
Subjects who are or will be inpatient.

Key Exclusion Criteria:

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)
Subjects with infectious diseases such as bacteremia or severe pneumonia requiring active treatment within four weeks prior to the IP administration