Phase 2 N=132 Randomized Triple-blind Treatment

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

Pneumonitis · SARS-CoV Infection

Bottom Line

View on ClinicalTrials.gov: NCT04590547 ↗

Enrolled (actual)

132

Serious AEs

3.0%

Results posted

Apr 2025

Primary outcome: Primary: Number of Serious Adverse Events Relative to Treatment Group — 1; 3; 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: GLS-1027 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GeneOne Life Science, Inc.
Primary completion: Aug 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Serious Adverse Events Relative to Treatment Group	1; 3; 0	—
PRIMARY Number of Treatment Failures at Day 28 From Enrollment	1; 3; 2	—
SECONDARY Assess the Number of Days of Hospitalization Relative to Treatment Group	9.3; 9.3; 9.4	—
SECONDARY Assess the Number of Days Requiring ICU Care Relative to Treatment Group	0; 4; 0	—
SECONDARY Assess the Number of Days of NIV, High-flow O2, or Mechanical Ventilation Relative to Treatment Group	6.7; 7.4; 6.1	—
SECONDARY Assess the Maximal Level of Positive End-Expiratory Pressure (PEEP) for Subjects Who Are Intubated Relative to Treatment Group.	0; 0; 0	—
SECONDARY Assess the Number of Days of PEEP > 5 cm H2O for Subjects Who Are Intubated Relative to Treatment Group	0; 0; 0	—

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04590547). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.