GLS-1027 for the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection (COVID-19)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety, Tolerability and Efficacy and Dose Response of GLS-1027 in the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection

Conditions
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Pneumonitis, SARS-CoV Infection

Intervention / Treatment
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* Drug: GLS-1027
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLS-1027 120 mg<br>One 120 mg pill of GLS-1027 + 2 Placebo pills given by mouth once daily | Drug: GLS-1027<br>* GLS-1027 is an oral medication with high bioavailability that has IL-6 and IL-1β inhibitory activity.<br>|
| Experimental: GLS-1027 360 mg<br>Three 120 mg pills of GLS-1027 given by mouth once daily | Drug: GLS-1027<br>* GLS-1027 is an oral medication with high bioavailability that has IL-6 and IL-1β inhibitory activity.<br>|
| Placebo Comparator: Placebo<br>Three Placebo pills given by mouth once daily | Drug: Placebo<br>* Placebo looks like GLS-1027<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19