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

Purpose

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

Conditions

  • Pneumonitis
  • SARS-CoV Infection

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.
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.
Placebo Comparator
Placebo 		Three Placebo pills given by mouth once daily
  • Drug: Placebo
    Placebo looks like GLS-1027

Recruiting Locations

More Details

NCT ID
NCT04590547
Status
Completed
Sponsor
GeneOne Life Science, Inc.

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.