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

NCT04590547 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: GLS27-005
• Study Type: interventional
• Target: 132
• Locations: 5 countries
• Sites: 17

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

Conditions

Pneumonitis; SARS-CoV Infection

Keywords

COVID-19

Outcome Measures

Primary Outcomes (2)

• Number of Serious Adverse Events Relative to Treatment Group

  28 days

• Number of Treatment Failures at Day 28 From Enrollment

  28 days

Secondary Outcomes (5)

• 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

Study Arms (3)

GLS-1027 120 mg

EXPERIMENTAL

One 120 mg pill of GLS-1027 + 2 Placebo pills given by mouth once daily

Drug: GLS-1027

GLS-1027 360 mg

EXPERIMENTAL

Three 120 mg pills of GLS-1027 given by mouth once daily

Drug: GLS-1027

Placebo

PLACEBO COMPARATOR

Three Placebo pills given by mouth once daily

Drug: Placebo

Interventions

GLS-1027 DRUG

GLS-1027 is an oral medication with high bioavailability that has IL-6 and IL-1β inhibitory activity.

GLS-1027 120 mg; GLS-1027 360 mg

Placebo DRUG

Placebo looks like GLS-1027

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GeneOne Life Science, Inc.: lead

Study Sites (17)

Baton Rouge General Medical Center

Baton Rouge, Louisiana, 70809, United States

Location

MHAT Kozlodui

Kozloduy, Bulgaria

Location

SHATPPD d-r Dimitar Gramatikov, Department of Pneumology

Rousse, Bulgaria

Location

UMHAT MEDICA RUSE LTD, Internal Diseases Department/Covid

Rousse, Bulgaria

Location

Military MHAT Sliven

Sliven, Bulgaria

Location

UHAT Aleksandrovska

Sofia, Bulgaria

Location

PHI Clinical Hospital - Shtip, Department for Infectious Diseases and Febrile Conditions

Skopje, North Macedonia

Location

PHI General City Hospital "8mi Septemvri" - COVID-19 Intensive Care Department

Skopje, North Macedonia

Location

PHI University Clinic for Pulmonology and Allergology

Skopje, North Macedonia

Location

PHI University Clinic of Infectious Diseases and Febrile Conditions

Skopje, North Macedonia

Location

PHI General Hospital Struga bb, Quay "8-mi Noemvri"

Struga, North Macedonia

Location

University of Puerto Rico

San Juan, 00935, Puerto Rico

Location

Korea University Ansan Hospital

Ansan-si, South Korea

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Pneumonia; Severe Acute Respiratory Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Pneumonia, Viral

Results Point of Contact

• Title: Senior Clinical Operations Associate
• Organization: GeneOne Life Science

dkane@genels.us

6106576351

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 19, 2020
• Study Start: May 7, 2021
• Primary Completion: August 14, 2022
• Study Completion: July 24, 2023
• Last Updated: April 11, 2025
• Results First Posted: April 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (5); US (1); KR (5); PR (1); BU (5)