Status:
TERMINATED
Safety and Preliminary Efficacy Study of GX-I7 in Patients With COVID-19
Lead Sponsor:
Genexine, Inc.
Conditions:
Covid19
Eligibility:
All Genders
19+ years
Phase:
PHASE1
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 des...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
March 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04730427
Start Date
March 24 2021
End Date
July 7 2022
Last Update
November 30 2022
Active Locations (1)
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1
Borame Medical Center
Seoul, South Korea, 07061