GLS-1027 for the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection (COVID-19)
NCT ID: NCT04590547
Last Updated: 2025-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
132 participants
INTERVENTIONAL
2021-05-07
2023-07-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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GLS-1027 120 mg
One 120 mg pill of GLS-1027 + 2 Placebo pills given by mouth once daily
GLS-1027
GLS-1027 is an oral medication with high bioavailability that has IL-6 and IL-1β inhibitory activity.
GLS-1027 360 mg
Three 120 mg pills of GLS-1027 given by mouth once daily
GLS-1027
GLS-1027 is an oral medication with high bioavailability that has IL-6 and IL-1β inhibitory activity.
Placebo
Three Placebo pills given by mouth once daily
Placebo
Placebo looks like GLS-1027
Interventions
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GLS-1027
GLS-1027 is an oral medication with high bioavailability that has IL-6 and IL-1β inhibitory activity.
Placebo
Placebo looks like GLS-1027
Eligibility Criteria
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Inclusion Criteria
* Able to provide consent
* Able and willing to comply with study procedures
* Diagnosis of PCR confirmed SARS-CoV-2
* Enrollment within 72 of hospitalization
* WHO COVID-19 classification level 3 or 4
Exclusion Criteria
* Need for mechanical ventilation, non-invasive ventilation (NIV), or high-flow O2 (≥60%) via face mask
* Calculated GFR \< 60 (Cockcroft-Gault)
* Meets treatment algorithm criteria for treatment with a non-study immune modulator
* Pre-study or planned treatment with a non-study immune modulator
* Participation in a COVID-19 clinical trial that includes prescription of a drug with anti-cytokine activity
* Status post transplantation of an organ, bone marrow, or body part
* Treatment within the past 60 days with a chemotherapeutic agent
* Diagnosis of leukemia or lymphoma
* WHO COVID-19 classification level of 5 or greater
* Unable to take oral medication
* Grade 3 or greater laboratory abnormalities as characterized by CTCAE v5
18 Years
ALL
No
Sponsors
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GeneOne Life Science, Inc.
INDUSTRY
Responsible Party
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Locations
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Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States
MHAT Kozlodui
Kozloduy, , Bulgaria
SHATPPD d-r Dimitar Gramatikov, Department of Pneumology
Rousse, , Bulgaria
UMHAT MEDICA RUSE LTD, Internal Diseases Department/Covid
Rousse, , Bulgaria
Military MHAT Sliven
Sliven, , Bulgaria
UHAT Aleksandrovska
Sofia, , Bulgaria
PHI Clinical Hospital - Shtip, Department for Infectious Diseases and Febrile Conditions
Skopje, , North Macedonia
PHI General City Hospital "8mi Septemvri" - COVID-19 Intensive Care Department
Skopje, , North Macedonia
PHI University Clinic for Pulmonology and Allergology
Skopje, , North Macedonia
PHI University Clinic of Infectious Diseases and Febrile Conditions
Skopje, , North Macedonia
PHI General Hospital Struga bb, Quay "8-mi Noemvri"
Struga, , North Macedonia
University of Puerto Rico
San Juan, , Puerto Rico
Korea University Ansan Hospital
Ansan-si, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Inha University Hospital
Incheon, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GLS27-005
Identifier Type: -
Identifier Source: org_study_id
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