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CompletedNCT04590547Updated Apr 11, 2025Results posted

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

A Phase 2 interventional study of GLS-1027 and Placebo in Pneumonitis and SARS-CoV Infection, sponsored by GeneOne Life Science, Inc.. Completed at 17 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-11.

Sponsored by GeneOne Life Science, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Pneumonitis
  • SARS-CoV Infection

Keywords

  • COVID-19
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 132 is close to the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

GeneOne Life Science, Inc. is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
132 participants (actual)

Study arms

  • Experimental
    GLS-1027 120 mg

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

    Drug: GLS-1027

  • Experimental
    GLS-1027 360 mg

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

    Drug: GLS-1027

  • Placebo comparator
    Placebo

    Three Placebo pills given by mouth once daily

    Drug: Placebo

Interventions

  • DrugGLS-1027

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

  • DrugPlacebo

    Placebo looks like GLS-1027

06

What researchers measure

Primary outcomes

  1. Number of Serious Adverse Events Relative to Treatment Group

    Time frame: 28 days

  2. Number of Treatment Failures at Day 28 From Enrollment

    Time frame: 28 days

Secondary outcomes

  1. Assess the Number of Days of Hospitalization Relative to Treatment Group

    Time frame: 28 days

  2. Assess the Number of Days Requiring ICU Care Relative to Treatment Group

    Time frame: 28 days

  3. Assess the Number of Days of NIV, High-flow O2, or Mechanical Ventilation Relative to Treatment Group

    Time frame: 28 days

  4. Assess the Maximal Level of Positive End-Expiratory Pressure (PEEP) for Subjects Who Are Intubated Relative to Treatment Group.

    Time frame: 28 days

  5. Assess the Number of Days of PEEP > 5 cm H2O for Subjects Who Are Intubated Relative to Treatment Group

    Time frame: 28 days

07

Results

Posted Apr 11, 2025

Participant flow

Participant flow — Overall Study
MilestoneGLS-1027 120 mgGLS-1027 360 mgPlacebo
Started424644
Completed394341
Not completed333

Outcome measures

PrimaryNumber of Serious Adverse Events Relative to Treatment Group
Time frame:
28 days
Reported as:
Number · participants
Number of Serious Adverse Events Relative to Treatment Group
participantsGLS-1027 120 mgGLS-1027 360 mgPlacebo
Number of Serious Adverse Events Relative to Treatment Group130
PrimaryNumber of Treatment Failures at Day 28 From Enrollment
Time frame:
28 days
Reported as:
Number · participants
Number of Treatment Failures at Day 28 From Enrollment
participantsGLS-1027 120 mgGLS-1027 360 mgPlacebo
Number of Treatment Failures at Day 28 From Enrollment132
SecondaryAssess the Number of Days of Hospitalization Relative to Treatment Group
Time frame:
28 days
Reported as:
Mean · days
Assess the Number of Days of Hospitalization Relative to Treatment Group
daysGLS-1027 120 mgGLS-1027 360 mgPlacebo
Assess the Number of Days of Hospitalization Relative to Treatment Group9.3 ± 4.209.3 ± 3.659.4 ± 4.10
SecondaryAssess the Number of Days Requiring ICU Care Relative to Treatment Group
Time frame:
28 days
Reported as:
Mean · Days ICU care
Assess the Number of Days Requiring ICU Care Relative to Treatment Group
Days ICU careGLS-1027 120 mgGLS-1027 360 mgPlacebo
Assess the Number of Days Requiring ICU Care Relative to Treatment Group0 (0 to 0)4 (4 to 4)0 (0 to 0)
SecondaryAssess the Number of Days of NIV, High-flow O2, or Mechanical Ventilation Relative to Treatment Group
Time frame:
28 days
Reported as:
Mean · days
Assess the Number of Days of NIV, High-flow O2, or Mechanical Ventilation Relative to Treatment Group
daysGLS-1027 120 mgGLS-1027 360 mgPlacebo
Assess the Number of Days of NIV, High-flow O2, or Mechanical Ventilation Relative to Treatment Group6.7 ± 4.867.4 ± 4.436.1 ± 4.03
SecondaryAssess the Maximal Level of Positive End-Expiratory Pressure (PEEP) for Subjects Who Are Intubated Relative to Treatment Group.
Time frame:
28 days
Reported as:
Mean · cm H2O
Assess the Maximal Level of Positive End-Expiratory Pressure (PEEP) for Subjects Who Are Intubated Relative to Treatment Group.
cm H2OGLS-1027 120 mgGLS-1027 360 mgPlacebo
Assess the Maximal Level of Positive End-Expiratory Pressure (PEEP) for Subjects Who Are Intubated Relative to Treatment Group.0 (0 to 0)0 (0 to 0)0 (0 to 0)
SecondaryAssess the Number of Days of PEEP > 5 cm H2O for Subjects Who Are Intubated Relative to Treatment Group
Time frame:
28 days
Reported as:
Mean · Days intubated PEEP > 5 cm H2O
Assess the Number of Days of PEEP > 5 cm H2O for Subjects Who Are Intubated Relative to Treatment Group
Days intubated PEEP > 5 cm H2OGLS-1027 120 mgGLS-1027 360 mgPlacebo
Assess the Number of Days of PEEP > 5 cm H2O for Subjects Who Are Intubated Relative to Treatment Group0 (0 to 0)0 (0 to 0)0 (0 to 0)

Adverse events

Collected over Adverse events were collected from the time of consent, daily while hospitalized (up to 15 days) and at days 28 and 56 by hospital records or telephone if discharged.. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
GLS-1027 120 mg1/42 (2.4%)1/42 (2.4%)2/42 (4.8%)
GLS-1027 360 mg1/46 (2.2%)3/46 (6.5%)3/46 (6.5%)
Placebo0/44 (0%)0/44 (0%)1/44 (2.3%)
Most frequent serious events
Most frequent serious events
EventGLS-1027 120 mgGLS-1027 360 mgPlacebo
Cardiopulmonary failureCardiac disorders1/420/460/44
Cerebrovascular accidentNervous system disorders0/421/460/44
Ischaemic strokeNervous system disorders0/421/460/44
Respiratory failureRespiratory, thoracic and mediastinal disorders0/421/460/44
Most frequent other events
Most frequent other events
EventGLS-1027 120 mgGLS-1027 360 mgPlacebo
Oral CandidiasisInfections and infestations2/423/461/44

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)GLS-1027 120 mgGLS-1027 360 mgPlaceboTotal
<=18 years0000
Between 18 and 65 years28323898
>=65 years1414634
Age, Continuous
Age, Continuous(years)GLS-1027 120 mgGLS-1027 360 mgPlaceboTotal
Mean52.7 ± 16.8153.9 ± 15.3852.2 ± 13.2353.0 ± 15.09
Sex: Female, Male
Sex: Female, Male(Participants)GLS-1027 120 mgGLS-1027 360 mgPlaceboTotal
Female27282782
Male15181750
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)GLS-1027 120 mgGLS-1027 360 mgPlaceboTotal
Hispanic or Latino0000
Not Hispanic or Latino424644132
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)GLS-1027 120 mgGLS-1027 360 mgPlaceboTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American0000
White424644132
More than one race0000
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)GLS-1027 120 mgGLS-1027 360 mgPlaceboTotal
North Macedonia353436105
Bulgaria711725
United States0112
08

Study locations

17 sites
  • Baton Rouge General Medical Center
    Baton Rouge, Louisiana 70809, United States
  • MHAT Kozlodui
    Kozloduy, Bulgaria
  • SHATPPD d-r Dimitar Gramatikov, Department of Pneumology
    Ruse, Bulgaria
  • UMHAT MEDICA RUSE LTD, Internal Diseases Department/Covid
    Ruse, Bulgaria
  • Military MHAT Sliven
    Sliven, Bulgaria
  • UHAT Aleksandrovska
    Sofia, Bulgaria
  • Korea University Ansan Hospital
    Ansan-si, Korea, Republic of
  • Gachon University Gil Medical Center
    Incheon, Korea, Republic of
  • Inha University Hospital
    Incheon, Korea, Republic of
  • Korea University Anam Hospital
    Seoul, Korea, Republic of
  • Korea University Guro Hospital
    Seoul, Korea, Republic of
  • 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
    Skopje, North Macedonia
  • PHI General Hospital Struga bb, Quay "8-mi Noemvri"
    Struga, North Macedonia
  • University of Puerto Rico
    San Juan, 00935, Puerto Rico
09

References and documents

Study documents

  • Study protocol · Dec 11, 2020
  • Statistical analysis plan · Dec 3, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04590547
Lead sponsor
GeneOne Life Science, Inc.
Responsible party
Sponsor
First posted
Oct 19, 2020
Start date
May 7, 2021
Primary completion
Aug 14, 2022
Completion
Jul 24, 2023
Results posted
Apr 11, 2025
Last update
Apr 11, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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