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

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GeneOne Life Science, Inc.

Criteria

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