Pneumonitis, SARS-CoV Infection
Conditions
Keywords
COVID-19
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.
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
Sponsors
GeneOne Life Science, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Serious Adverse Events Relative to Treatment Group | 28 days |
| Number of Treatment Failures at Day 28 From Enrollment | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Assess the Number of Days of NIV, High-flow O2, or Mechanical Ventilation Relative to Treatment Group | 28 days |
| Assess the Number of Days of Hospitalization 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 |
| 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 Requiring ICU Care Relative to Treatment Group | 28 days |
Countries
Bulgaria, North Macedonia, Puerto Rico, South Korea, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GLS-1027 120 mg One 120 mg pill of GLS-1027 + 2 Placebo pills given by mouth once daily
GLS-1027: GLS-1027 is an oral medication with high bioavailability that has IL-6 and IL-1β inhibitory activity. | 42 |
| GLS-1027 360 mg Three 120 mg pills of GLS-1027 given by mouth once daily
GLS-1027: GLS-1027 is an oral medication with high bioavailability that has IL-6 and IL-1β inhibitory activity. | 46 |
| Placebo Three Placebo pills given by mouth once daily
Placebo: Placebo looks like GLS-1027 | 44 |
| Total | 132 |
Baseline characteristics
| Characteristic | GLS-1027 120 mg | GLS-1027 360 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 14 Participants | 6 Participants | 34 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 32 Participants | 38 Participants | 98 Participants |
| Age, Continuous | 52.7 years STANDARD_DEVIATION 16.81 | 53.9 years STANDARD_DEVIATION 15.38 | 52.2 years STANDARD_DEVIATION 13.23 | 53.0 years STANDARD_DEVIATION 15.09 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 46 Participants | 44 Participants | 132 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 42 Participants | 46 Participants | 44 Participants | 132 Participants |
| Region of Enrollment Bulgaria | 7 participants | 11 participants | 7 participants | 25 participants |
| Region of Enrollment North Macedonia | 35 participants | 34 participants | 36 participants | 105 participants |
| Region of Enrollment United States | 0 participants | 1 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 27 Participants | 28 Participants | 27 Participants | 82 Participants |
| Sex: Female, Male Male | 15 Participants | 18 Participants | 17 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 42 | 1 / 46 | 0 / 44 |
| other Total, other adverse events | 2 / 42 | 3 / 46 | 1 / 44 |
| serious Total, serious adverse events | 1 / 42 | 3 / 46 | 0 / 44 |
Outcome results
Primary
Number of Serious Adverse Events Relative to Treatment Group
Time frame: 28 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GLS-1027 120 mg | Number of Serious Adverse Events Relative to Treatment Group | 1 participants |
| GLS-1027 360 mg | Number of Serious Adverse Events Relative to Treatment Group | 3 participants |
| Placebo | Number of Serious Adverse Events Relative to Treatment Group | 0 participants |
Primary
Number of Treatment Failures at Day 28 From Enrollment
Time frame: 28 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GLS-1027 120 mg | Number of Treatment Failures at Day 28 From Enrollment | 1 participants |
| GLS-1027 360 mg | Number of Treatment Failures at Day 28 From Enrollment | 3 participants |
| Placebo | Number of Treatment Failures at Day 28 From Enrollment | 2 participants |
Secondary
Assess the Maximal Level of Positive End-Expiratory Pressure (PEEP) for Subjects Who Are Intubated Relative to Treatment Group.
Time frame: 28 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GLS-1027 120 mg | Assess the Maximal Level of Positive End-Expiratory Pressure (PEEP) for Subjects Who Are Intubated Relative to Treatment Group. | 0 cm H2O |
| GLS-1027 360 mg | Assess the Maximal Level of Positive End-Expiratory Pressure (PEEP) for Subjects Who Are Intubated Relative to Treatment Group. | 0 cm H2O |
| Placebo | Assess the Maximal Level of Positive End-Expiratory Pressure (PEEP) for Subjects Who Are Intubated Relative to Treatment Group. | 0 cm H2O |
Secondary
Assess the Number of Days of Hospitalization Relative to Treatment Group
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GLS-1027 120 mg | Assess the Number of Days of Hospitalization Relative to Treatment Group | 9.3 days | Standard Deviation 4.2 |
| GLS-1027 360 mg | Assess the Number of Days of Hospitalization Relative to Treatment Group | 9.3 days | Standard Deviation 3.65 |
| Placebo | Assess the Number of Days of Hospitalization Relative to Treatment Group | 9.4 days | Standard Deviation 4.1 |
Secondary
Assess the Number of Days of NIV, High-flow O2, or Mechanical Ventilation Relative to Treatment Group
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GLS-1027 120 mg | Assess the Number of Days of NIV, High-flow O2, or Mechanical Ventilation Relative to Treatment Group | 6.7 days | Standard Deviation 4.86 |
| GLS-1027 360 mg | Assess the Number of Days of NIV, High-flow O2, or Mechanical Ventilation Relative to Treatment Group | 7.4 days | Standard Deviation 4.43 |
| Placebo | Assess the Number of Days of NIV, High-flow O2, or Mechanical Ventilation Relative to Treatment Group | 6.1 days | Standard Deviation 4.03 |
Secondary
Assess the Number of Days of PEEP > 5 cm H2O for Subjects Who Are Intubated Relative to Treatment Group
Time frame: 28 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GLS-1027 120 mg | Assess the Number of Days of PEEP > 5 cm H2O for Subjects Who Are Intubated Relative to Treatment Group | 0 Days intubated PEEP > 5 cm H2O |
| GLS-1027 360 mg | Assess the Number of Days of PEEP > 5 cm H2O for Subjects Who Are Intubated Relative to Treatment Group | 0 Days intubated PEEP > 5 cm H2O |
| Placebo | Assess the Number of Days of PEEP > 5 cm H2O for Subjects Who Are Intubated Relative to Treatment Group | 0 Days intubated PEEP > 5 cm H2O |
Secondary
Assess the Number of Days Requiring ICU Care Relative to Treatment Group
Time frame: 28 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GLS-1027 120 mg | Assess the Number of Days Requiring ICU Care Relative to Treatment Group | 0 Days ICU care |
| GLS-1027 360 mg | Assess the Number of Days Requiring ICU Care Relative to Treatment Group | 4 Days ICU care |
| Placebo | Assess the Number of Days Requiring ICU Care Relative to Treatment Group | 0 Days ICU care |