- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04590547
GLS-1027 for the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection (COVID-19)
September 11, 2023 updated by: GeneOne Life Science, Inc.
Safety, Tolerability and Efficacy and Dose Response of GLS-1027 in the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection
This clinical trial will evaluate the safety, tolerability and efficacy of GLS-1027 in the prevention of severe pneumonitis caused by SARS-CoV-2 infection
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This Phase II randomized, double-blind, placebo-controlled, study will assess 2 different doses of GLS-1027 in the prevention of severe pneumonitis among those hospitalized with PCR confirmed SARS-CoV-2 infection.
Subjects will be randomized at a 1:1:1 ratio to either Standard of Care (SOC) plus placebo, or SOC plus GLS-1027 at either 120 mg or 360 mg daily.
Clinical status will be monitored through 56 days from the initiation of treatment.
Study Type
Interventional
Enrollment (Actual)
132
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kozloduy, Bulgaria
- MHAT Kozlodui
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Ruse, Bulgaria
- SHATPPD d-r Dimitar Gramatikov, Department of Pneumology
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Ruse, Bulgaria
- UMHAT MEDICA RUSE LTD, Internal Diseases Department/Covid
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Sliven, Bulgaria
- Military MHAT Sliven
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Sofia, Bulgaria
- UHAT Aleksandrovska
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Ansan-si, Korea, Republic of
- Korea University Ansan Hospital
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Incheon, Korea, Republic of
- Inha University Hospital
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Incheon, Korea, Republic of
- Gachon University Gil Medical Center
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Seoul, Korea, Republic of
- Korea University Guro Hospital
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Seoul, Korea, Republic of
- Korea University Anam Hospital
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Skopje, North Macedonia
- PHI Clinical Hospital - Shtip, Department for Infectious Diseases and Febrile Conditions
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Skopje, North Macedonia
- PHI General City Hospital "8mi Septemvri" - COVID-19 Intensive Care Department
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Skopje, North Macedonia
- PHI University Clinic for Pulmonology and Allergology
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Skopje, North Macedonia
- PHI University Clinic of Infectious Diseases and Febrile Conditions
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Struga, North Macedonia
- PHI General Hospital Struga bb, Quay "8-mi Noemvri"
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San Juan, Puerto Rico, 00935
- University of Puerto Rico
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- Baton Rouge General Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 18 years or older
- 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:
- Pregnant or lactating
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GLS-1027 120 mg
One 120 mg pill of GLS-1027 + 2 Placebo pills given by mouth once daily
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GLS-1027 is an oral medication with high bioavailability that has IL-6 and IL-1β inhibitory activity.
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Experimental: GLS-1027 360 mg
Three 120 mg pills of GLS-1027 given by mouth once daily
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GLS-1027 is an oral medication with high bioavailability that has IL-6 and IL-1β inhibitory activity.
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Placebo Comparator: Placebo
Three Placebo pills given by mouth once daily
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Placebo looks like GLS-1027
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of serious adverse events relative to treatment group
Time Frame: 28 days
|
28 days
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Incidence of treatment failure at day 28 from enrollment
Time Frame: 28 days
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28 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assess the number of days of hospitalization relative to treatment group
Time Frame: 28 days
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28 days
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Assess the number of days requiring ICU care relative to treatment group
Time Frame: 28 days
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28 days
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Assess the number of days of NIV, high-flow O2, or mechanical ventilation relative to treatment
Time Frame: 28 days
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28 days
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Assess the maximal level of Positive End-Expiratory Pressure (PEEP) for subjects who are intubated relative to treatment group.
Time Frame: 28 days
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28 days
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Assess the number of days of PEEP > 5 cm H2O for subjects who are intubated relative to treatment group
Time Frame: 28 days
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28 days
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Difference in WHO Classification level at day 28 from enrollment
Time Frame: 28 days
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28 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 7, 2021
Primary Completion (Actual)
August 14, 2022
Study Completion (Estimated)
December 1, 2023
Study Registration Dates
First Submitted
October 13, 2020
First Submitted That Met QC Criteria
October 13, 2020
First Posted (Actual)
October 19, 2020
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 11, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Lung Diseases
- Disease Attributes
- Severe Acute Respiratory Syndrome
- COVID-19
- Infections
- Communicable Diseases
- Pneumonia
Other Study ID Numbers
- GLS27-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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