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

GeneOne Life Science

Status and phase: Active, not recruiting; Phase 2

Conditions: Pneumonitis; SARS-CoV Infection

Treatments: Drug: Placebo; Drug: GLS-1027

Study type: Interventional

Funder types: Industry

Identifiers

NCT04590547

GLS27-005

Details and patient eligibility

About

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

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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132 participants in 3 patient groups, including a placebo group

GLS-1027 120 mg

Experimental group

Description:

One 120 mg pill of GLS-1027 + 2 Placebo pills given by mouth once daily

Treatment:

Drug: GLS-1027

GLS-1027 360 mg

Experimental group

Description:

Three 120 mg pills of GLS-1027 given by mouth once daily

Treatment:

Drug: GLS-1027

Placebo

Placebo Comparator group

Description:

Three Placebo pills given by mouth once daily

Treatment:

Drug: Placebo