Overview

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