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

Phase 2

Completed

• Conditions: Pneumonitis; SARS-CoV Infection
• Interventions: Drug: GLS-1027; Drug: Placebo

• Registration Number: NCT04590547
• Lead Sponsor: GeneOne Life Science, Inc.

Brief 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

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.

Study Timeline

• Study First Submitted: 2020-10-13
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-19
• Study Start: 2021-05-07
• Primary Completion: 2022-08-14
• Study Completion: 2023-07-24
• Results First Submitted: 2025-01-17
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-26
• Last Update Submitted: 2025-03-26
• Results First Posted: 2025-04-11
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLS-1027 120 mg	GLS-1027	One 120 mg pill of GLS-1027 + 2 Placebo pills given by mouth once daily
Placebo	Placebo	Three Placebo pills given by mouth once daily
GLS-1027 360 mg	GLS-1027	Three 120 mg pills of GLS-1027 given by mouth once daily

Primary Outcome Measures

Name	Time	Method
Number of Serious Adverse Events Relative to Treatment Group	28 days
Number of Treatment Failures at Day 28 From Enrollment	28 days

Secondary Outcome Measures

Name	Time	Method
Assess the Number of Days of Hospitalization Relative to Treatment Group	28 days
Assess the Number of Days Requiring ICU Care Relative to Treatment Group	28 days
Assess the Number of Days of NIV, High-flow O2, or Mechanical Ventilation Relative to Treatment Group	28 days
Assess the Maximal Level of Positive End-Expiratory Pressure (PEEP) for Subjects Who Are Intubated Relative to Treatment Group.	28 days
Assess the Number of Days of PEEP > 5 cm H2O for Subjects Who Are Intubated Relative to Treatment Group	28 days

Trial Locations

Locations (17)

MHAT Kozlodui; 🇧🇬 Kozloduy, Bulgaria

SHATPPD d-r Dimitar Gramatikov, Department of Pneumology; 🇧🇬 Ruse, Bulgaria

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of

UHAT Aleksandrovska; 🇧🇬 Sofia, Bulgaria

Korea University Ansan Hospital; 🇰🇷 Ansan-si, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

PHI Clinical Hospital - Shtip, Department for Infectious Diseases and Febrile Conditions; 🇲🇰 Skopje, North Macedonia

PHI General Hospital Struga bb, Quay "8-mi Noemvri"; 🇲🇰 Struga, North Macedonia

UMHAT MEDICA RUSE LTD, Internal Diseases Department/Covid; 🇧🇬 Ruse, Bulgaria

Military MHAT Sliven; 🇧🇬 Sliven, Bulgaria

PHI University Clinic of Infectious Diseases and Febrile Conditions; 🇲🇰 Skopje, North Macedonia

Baton Rouge General Medical Center; 🇺🇸 Baton Rouge, Louisiana, United States

PHI General City Hospital "8mi Septemvri" - COVID-19 Intensive Care Department; 🇲🇰 Skopje, North Macedonia

PHI University Clinic for Pulmonology and Allergology; 🇲🇰 Skopje, North Macedonia

University of Puerto Rico; 🇵🇷 San Juan, Puerto Rico