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

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

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.

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