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

September 11, 2023 updated by: GeneOne Life Science, Inc.

Safety, Tolerability and Efficacy and Dose Response of GLS-1027 in the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection

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

Study Overview

Status

Active, not recruiting

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kozloduy, Bulgaria
        • MHAT Kozlodui
      • Ruse, Bulgaria
        • SHATPPD d-r Dimitar Gramatikov, Department of Pneumology
      • Ruse, Bulgaria
        • UMHAT MEDICA RUSE LTD, Internal Diseases Department/Covid
      • Sliven, Bulgaria
        • Military MHAT Sliven
      • Sofia, Bulgaria
        • UHAT Aleksandrovska
      • Ansan-si, Korea, Republic of
        • Korea University Ansan Hospital
      • Incheon, Korea, Republic of
        • Inha University Hospital
      • Incheon, Korea, Republic of
        • Gachon University Gil Medical Center
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital
      • Skopje, North Macedonia
        • PHI Clinical Hospital - Shtip, Department for Infectious Diseases and Febrile Conditions
      • Skopje, North Macedonia
        • PHI General City Hospital "8mi Septemvri" - COVID-19 Intensive Care Department
      • Skopje, North Macedonia
        • PHI University Clinic for Pulmonology and Allergology
      • Skopje, North Macedonia
        • PHI University Clinic of Infectious Diseases and Febrile Conditions
      • Struga, North Macedonia
        • PHI General Hospital Struga bb, Quay "8-mi Noemvri"
      • San Juan, Puerto Rico, 00935
        • University of Puerto Rico
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Baton Rouge General Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GLS-1027 120 mg
One 120 mg pill of GLS-1027 + 2 Placebo pills given by mouth once daily
GLS-1027 is an oral medication with high bioavailability that has IL-6 and IL-1β inhibitory activity.
Experimental: GLS-1027 360 mg
Three 120 mg pills of GLS-1027 given by mouth once daily
GLS-1027 is an oral medication with high bioavailability that has IL-6 and IL-1β inhibitory activity.
Placebo Comparator: Placebo
Three Placebo pills given by mouth once daily
Placebo looks like GLS-1027

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of serious adverse events relative to treatment group
Time Frame: 28 days
28 days
Incidence of treatment failure at day 28 from enrollment
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess the number of days of hospitalization relative to treatment group
Time Frame: 28 days
28 days
Assess the number of days requiring ICU care relative to treatment group
Time Frame: 28 days
28 days
Assess the number of days of NIV, high-flow O2, or mechanical ventilation relative to treatment
Time Frame: 28 days
28 days
Assess the maximal level of Positive End-Expiratory Pressure (PEEP) for subjects who are intubated relative to treatment group.
Time Frame: 28 days
28 days
Assess the number of days of PEEP > 5 cm H2O for subjects who are intubated relative to treatment group
Time Frame: 28 days
28 days
Difference in WHO Classification level at day 28 from enrollment
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2021

Primary Completion (Actual)

August 14, 2022

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

October 13, 2020

First Submitted That Met QC Criteria

October 13, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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