Back to resultsGLS-1027 for the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection (COVID-19)
Primary Purpose
Pneumonitis, SARS-CoV Infection
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GLS-1027
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonitis focused on measuring COVID-19
Eligibility Criteria
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
Sites / Locations
- Baton Rouge General Medical Center
- MHAT Kozlodui
- SHATPPD d-r Dimitar Gramatikov, Department of Pneumology
- UMHAT MEDICA RUSE LTD, Internal Diseases Department/Covid
- Military MHAT Sliven
- UHAT Aleksandrovska
- Korea University Ansan Hospital
- Gachon University Gil Medical Center
- Inha University Hospital
- Korea University Anam Hospital
- Korea University Guro Hospital
- PHI Clinical Hospital - Shtip, Department for Infectious Diseases and Febrile Conditions
- PHI General City Hospital "8mi Septemvri" - COVID-19 Intensive Care Department
- PHI University Clinic for Pulmonology and Allergology
- PHI University Clinic of Infectious Diseases and Febrile Conditions
- PHI General Hospital Struga bb, Quay "8-mi Noemvri"
- University of Puerto Rico
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
GLS-1027 120 mg
GLS-1027 360 mg
Placebo
Arm Description
One 120 mg pill of GLS-1027 + 2 Placebo pills given by mouth once daily
Three 120 mg pills of GLS-1027 given by mouth once daily
Three Placebo pills given by mouth once daily
Outcomes
Primary Outcome Measures
Incidence of serious adverse events relative to treatment group
Incidence of treatment failure at day 28 from enrollment
Secondary Outcome Measures
Assess the number of days of hospitalization relative to treatment group
Assess the number of days requiring ICU care relative to treatment group
Assess the number of days of NIV, high-flow O2, or mechanical ventilation relative to treatment
Assess the maximal level of Positive End-Expiratory Pressure (PEEP) for subjects who are intubated relative to treatment group.
Assess the number of days of PEEP > 5 cm H2O for subjects who are intubated relative to treatment group
Difference in WHO Classification level at day 28 from enrollment
Full Information
NCT ID
NCT04590547
First Posted
October 13, 2020
Last Updated
September 11, 2023
Sponsor
GeneOne Life Science, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04590547
Brief Title
GLS-1027 for the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection (COVID-19)
Official Title
Safety, Tolerability and Efficacy and Dose Response of GLS-1027 in the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 7, 2021 (Actual)
Primary Completion Date
August 14, 2022 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GeneOne Life Science, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonitis, SARS-CoV Infection
Keywords
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GLS-1027 120 mg
Arm Type
Experimental
Arm Description
One 120 mg pill of GLS-1027 + 2 Placebo pills given by mouth once daily
Arm Title
GLS-1027 360 mg
Arm Type
Experimental
Arm Description
Three 120 mg pills of GLS-1027 given by mouth once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Three Placebo pills given by mouth once daily
Intervention Type
Drug
Intervention Name(s)
GLS-1027
Intervention Description
GLS-1027 is an oral medication with high bioavailability that has IL-6 and IL-1β inhibitory activity.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo looks like GLS-1027
Primary Outcome Measure Information:
Title
Incidence of serious adverse events relative to treatment group
Time Frame
28 days
Title
Incidence of treatment failure at day 28 from enrollment
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Assess the number of days of hospitalization relative to treatment group
Time Frame
28 days
Title
Assess the number of days requiring ICU care relative to treatment group
Time Frame
28 days
Title
Assess the number of days of NIV, high-flow O2, or mechanical ventilation relative to treatment
Time Frame
28 days
Title
Assess the maximal level of Positive End-Expiratory Pressure (PEEP) for subjects who are intubated relative to treatment group.
Time Frame
28 days
Title
Assess the number of days of PEEP > 5 cm H2O for subjects who are intubated relative to treatment group
Time Frame
28 days
Title
Difference in WHO Classification level at day 28 from enrollment
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Baton Rouge General Medical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
MHAT Kozlodui
City
Kozloduy
Country
Bulgaria
Facility Name
SHATPPD d-r Dimitar Gramatikov, Department of Pneumology
City
Ruse
Country
Bulgaria
Facility Name
UMHAT MEDICA RUSE LTD, Internal Diseases Department/Covid
City
Ruse
Country
Bulgaria
Facility Name
Military MHAT Sliven
City
Sliven
Country
Bulgaria
Facility Name
UHAT Aleksandrovska
City
Sofia
Country
Bulgaria
Facility Name
Korea University Ansan Hospital
City
Ansan-si
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
PHI Clinical Hospital - Shtip, Department for Infectious Diseases and Febrile Conditions
City
Skopje
Country
North Macedonia
Facility Name
PHI General City Hospital "8mi Septemvri" - COVID-19 Intensive Care Department
City
Skopje
Country
North Macedonia
Facility Name
PHI University Clinic for Pulmonology and Allergology
City
Skopje
Country
North Macedonia
Facility Name
PHI University Clinic of Infectious Diseases and Febrile Conditions
City
Skopje
Country
North Macedonia
Facility Name
PHI General Hospital Struga bb, Quay "8-mi Noemvri"
City
Struga
Country
North Macedonia
Facility Name
University of Puerto Rico
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
GLS-1027 for the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection (COVID-19)
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