GLS-1027 for the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection (COVID-19)
Study Details
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
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: GLS-1027 120 mg One 120 mg pill of GLS-1027 + 2 Placebo pills given by mouth once daily |
Drug: GLS-1027
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 |
Drug: GLS-1027
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 |
Drug: Placebo
Placebo looks like GLS-1027
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Outcome Measures
Primary Outcome Measures
- Incidence of serious adverse events relative to treatment group [28 days]
- Incidence of treatment failure at day 28 from enrollment [28 days]
Secondary Outcome Measures
- Assess the number of days of hospitalization relative to treatment group [28 days]
- Assess the number of days requiring ICU care relative to treatment group [28 days]
- Assess the number of days of NIV, high-flow O2, or mechanical ventilation relative to treatment [28 days]
- Assess the maximal level of Positive End-Expiratory Pressure (PEEP) for subjects who are intubated relative to treatment group. [28 days]
- Assess the number of days of PEEP > 5 cm H2O for subjects who are intubated relative to treatment group [28 days]
- Difference in WHO Classification level at day 28 from enrollment [28 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 years or older
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Able to provide consent
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Able and willing to comply with study procedures
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Diagnosis of PCR confirmed SARS-CoV-2
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Enrollment within 72 of hospitalization
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WHO COVID-19 classification level 3 or 4
Exclusion Criteria:
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Pregnant or lactating
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Need for mechanical ventilation, non-invasive ventilation (NIV), or high-flow O2 (≥60%) via face mask
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Calculated GFR < 60 (Cockcroft-Gault)
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Meets treatment algorithm criteria for treatment with a non-study immune modulator
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Pre-study or planned treatment with a non-study immune modulator
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Participation in a COVID-19 clinical trial that includes prescription of a drug with anti-cytokine activity
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Status post transplantation of an organ, bone marrow, or body part
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Treatment within the past 60 days with a chemotherapeutic agent
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Diagnosis of leukemia or lymphoma
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WHO COVID-19 classification level of 5 or greater
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Unable to take oral medication
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Grade 3 or greater laboratory abnormalities as characterized by CTCAE v5
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Baton Rouge General Medical Center | Baton Rouge | Louisiana | United States | 70809 |
2 | MHAT Kozlodui | Kozloduy | Bulgaria | ||
3 | SHATPPD d-r Dimitar Gramatikov, Department of Pneumology | Ruse | Bulgaria | ||
4 | UMHAT MEDICA RUSE LTD, Internal Diseases Department/Covid | Ruse | Bulgaria | ||
5 | Military MHAT Sliven | Sliven | Bulgaria | ||
6 | UHAT Aleksandrovska | Sofia | Bulgaria | ||
7 | Korea University Ansan Hospital | Ansan-si | Korea, Republic of | ||
8 | Gachon University Gil Medical Center | Incheon | Korea, Republic of | ||
9 | Inha University Hospital | Incheon | Korea, Republic of | ||
10 | Korea University Anam Hospital | Seoul | Korea, Republic of | ||
11 | Korea University Guro Hospital | Seoul | Korea, Republic of | ||
12 | PHI Clinical Hospital - Shtip, Department for Infectious Diseases and Febrile Conditions | Skopje | North Macedonia | ||
13 | PHI General City Hospital "8mi Septemvri" - COVID-19 Intensive Care Department | Skopje | North Macedonia | ||
14 | PHI University Clinic for Pulmonology and Allergology | Skopje | North Macedonia | ||
15 | PHI University Clinic of Infectious Diseases and Febrile Conditions | Skopje | North Macedonia | ||
16 | PHI General Hospital Struga bb, Quay "8-mi Noemvri" | Struga | North Macedonia | ||
17 | University of Puerto Rico | San Juan | Puerto Rico | 00935 |
Sponsors and Collaborators
- GeneOne Life Science, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GLS27-005