PneumonitisPhase 2NCT04590547
GLS-1027 for the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection (COVID-19)
A Phase 2 study testing GLS-1027 in people with Pneumonitis and SARS-CoV Infection, run by GeneOne Life Science, Inc. at 17 sites in 5 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonitis, SARS-CoV Infection
- What is being tested?
- GLS-1027
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 17 sitesin 5 countries
- Study dates
- 7 May 2021to 24 Jul 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
Bulgaria5 sites
MHAT Kozlodui
Kozloduy
SHATPPD d-r Dimitar Gramatikov, Department of Pneumology
Rousse
UMHAT MEDICA RUSE LTD, Internal Diseases Department/Covid
Rousse
Military MHAT Sliven
Sliven
UHAT Aleksandrovska
Sofia
North Macedonia5 sites
PHI Clinical Hospital - Shtip, Department for Infectious Diseases and Febrile Conditions
Skopje
PHI General City Hospital "8mi Septemvri" - COVID-19 Intensive Care Department
Skopje
PHI University Clinic for Pulmonology and Allergology
Skopje
PHI University Clinic of Infectious Diseases and Febrile Conditions
Skopje
PHI General Hospital Struga bb, Quay "8-mi Noemvri"
Struga
South Korea5 sites
Korea University Ansan Hospital
Ansan-si
Gachon University Gil Medical Center
Incheon
Inha University Hospital
Incheon
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
United States1 site
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70809
About this study
Official title: 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
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.
- Conditions
- Pneumonitis, SARS-CoV Infection
- Being tested
- GLS-1027, Placebo
- Keywords
- COVID-19
- Medical subject headings
- Pneumonia, Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLS-1027Drug
GLS-1027 is an oral medication with high bioavailability that has IL-6 and IL-1β inhibitory activity.
PlaceboDrug
Placebo looks like GLS-1027
| Study group | Role | What they receive |
|---|---|---|
| GLS-1027 120 mg | Experimental | One 120 mg pill of GLS-1027 + 2 Placebo pills given by mouth once daily Receives: Drug: GLS-1027 |
| GLS-1027 360 mg | Experimental | Three 120 mg pills of GLS-1027 given by mouth once daily Receives: Drug: GLS-1027 |
| Placebo | Placebo comparator | Three Placebo pills given by mouth once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Serious Adverse Events Relative to Treatment Group
Measured: 28 days
Number of Treatment Failures at Day 28 From Enrollment
Measured: 28 days
Secondary outcomes (5)
Assess the Number of Days of Hospitalization Relative to Treatment Group
Measured: 28 days
Assess the Number of Days Requiring ICU Care Relative to Treatment Group
Measured: 28 days
Assess the Number of Days of NIV, High-flow O2, or Mechanical Ventilation Relative to Treatment Group
Measured: 28 days
Assess the Maximal Level of Positive End-Expiratory Pressure (PEEP) for Subjects Who Are Intubated Relative to Treatment Group.
Measured: 28 days
Assess the Number of Days of PEEP > 5 cm H2O for Subjects Who Are Intubated Relative to Treatment Group
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start7 May 2021
- Primary completion14 Aug 2022
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PneumonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- GeneOne Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590547
- Sponsor's protocol ID
- GLS27-005
- Status last verified
- Mar 2025
- First submitted
- 13 Oct 2020
- Last updated
- 11 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Efficacy and Dose Response of GLS-1027 in the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04590547
- Acronym / sponsor ID
- GLS27-005
- Conditions
- Pneumonitis, SARS-CoV Infection
- Keywords
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- GeneOne Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 May 2021 (actual)
- Primary completion
- 14 Aug 2022 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Posted 11 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GLS-1027 120 mg | Experimental | Drug: GLS-1027One 120 mg pill of GLS-1027 + 2 Placebo pills given by mouth once daily |
| GLS-1027 360 mg | Experimental | Drug: GLS-1027Three 120 mg pills of GLS-1027 given by mouth once daily |
| Placebo | Placebo comparator | Drug: PlaceboThree Placebo pills given by mouth once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLS-1027GLS-1027 is an oral medication with high bioavailability that has IL-6 and IL-1β inhibitory activity. | Drug | GLS-1027 120 mg, GLS-1027 360 mg |
| PlaceboPlacebo looks like GLS-1027 | Drug | Placebo |
Primary outcome
Number of Serious Adverse Events Relative to Treatment Group
Time frame: 28 days
Number of Treatment Failures at Day 28 From Enrollment
Time frame: 28 days
5 secondary outcomes
Assess the Number of Days of Hospitalization Relative to Treatment Group
Time frame: 28 days
Assess the Number of Days Requiring ICU Care Relative to Treatment Group
Time frame: 28 days
Assess the Number of Days of NIV, High-flow O2, or Mechanical Ventilation Relative to Treatment Group
Time frame: 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
Assess the Number of Days of PEEP > 5 cm H2O for Subjects Who Are Intubated Relative to Treatment Group
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GLS-1027 in people with Pneumonitis and SARS-CoV Infection, run by GeneOne Life Science, Inc. at 17 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Bulgaria, North Macedonia, South Korea, United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Serious Adverse Events Relative to Treatment Group (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.