Trial Outcomes & Findings for GLS-1027 for the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection (COVID-19) (NCT NCT04590547)

NCT ID: NCT04590547

Last Updated: 2025-04-11

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 132 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2025-04-11

Participant Flow

Participant milestones

Measure	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.	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.	Placebo Three Placebo pills given by mouth once daily Placebo: Placebo looks like GLS-1027
Overall Study STARTED	42	46	44
Overall Study COMPLETED	39	43	41
Overall Study NOT COMPLETED	3	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	GLS-1027 120 mg n=42 Participants 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.	GLS-1027 360 mg n=46 Participants 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.	Placebo n=44 Participants Three Placebo pills given by mouth once daily Placebo: Placebo looks like GLS-1027	Total n=132 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants	32 Participants n=7 Participants	38 Participants n=5 Participants	98 Participants n=4 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	14 Participants n=7 Participants	6 Participants n=5 Participants	34 Participants n=4 Participants
Age, Continuous	52.7 years STANDARD_DEVIATION 16.81 • n=5 Participants	53.9 years STANDARD_DEVIATION 15.38 • n=7 Participants	52.2 years STANDARD_DEVIATION 13.23 • n=5 Participants	53.0 years STANDARD_DEVIATION 15.09 • n=4 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	28 Participants n=7 Participants	27 Participants n=5 Participants	82 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	18 Participants n=7 Participants	17 Participants n=5 Participants	50 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants	46 Participants n=7 Participants	44 Participants n=5 Participants	132 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants	46 Participants n=7 Participants	44 Participants n=5 Participants	132 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment North Macedonia	35 participants n=5 Participants	34 participants n=7 Participants	36 participants n=5 Participants	105 participants n=4 Participants
Region of Enrollment Bulgaria	7 participants n=5 Participants	11 participants n=7 Participants	7 participants n=5 Participants	25 participants n=4 Participants
Region of Enrollment United States	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants

PRIMARY outcome

Timeframe: 28 days

Outcome measures

Measure	GLS-1027 120 mg n=42 Participants 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.	GLS-1027 360 mg n=46 Participants 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.	Placebo n=44 Participants Three Placebo pills given by mouth once daily Placebo: Placebo looks like GLS-1027
Number of Serious Adverse Events Relative to Treatment Group	1 participants	3 participants	0 participants

PRIMARY outcome

Timeframe: 28 days

Outcome measures

Measure	GLS-1027 120 mg n=42 Participants 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.	GLS-1027 360 mg n=46 Participants 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.	Placebo n=44 Participants Three Placebo pills given by mouth once daily Placebo: Placebo looks like GLS-1027
Number of Treatment Failures at Day 28 From Enrollment	1 participants	3 participants	2 participants

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Measure	GLS-1027 120 mg n=42 Participants 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.	GLS-1027 360 mg n=46 Participants 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.	Placebo n=44 Participants Three Placebo pills given by mouth once daily Placebo: Placebo looks like GLS-1027
Assess the Number of Days of Hospitalization Relative to Treatment Group	9.3 days Standard Deviation 4.20	9.3 days Standard Deviation 3.65	9.4 days Standard Deviation 4.10

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Measure	GLS-1027 120 mg n=42 Participants 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.	GLS-1027 360 mg n=46 Participants 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.	Placebo n=44 Participants Three Placebo pills given by mouth once daily Placebo: Placebo looks like GLS-1027
Assess the Number of Days Requiring ICU Care Relative to Treatment Group	0 Days ICU care Interval 0.0 to 0.0	4 Days ICU care Interval 4.0 to 4.0	0 Days ICU care Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Measure	GLS-1027 120 mg n=42 Participants 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.	GLS-1027 360 mg n=46 Participants 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.	Placebo n=44 Participants Three Placebo pills given by mouth once daily Placebo: Placebo looks like GLS-1027
Assess the Number of Days of NIV, High-flow O2, or Mechanical Ventilation Relative to Treatment Group	6.7 days Standard Deviation 4.86	7.4 days Standard Deviation 4.43	6.1 days Standard Deviation 4.03

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Measure	GLS-1027 120 mg n=42 Participants 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.	GLS-1027 360 mg n=46 Participants 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.	Placebo n=44 Participants Three Placebo pills given by mouth once daily Placebo: Placebo looks like GLS-1027
Assess the Maximal Level of Positive End-Expiratory Pressure (PEEP) for Subjects Who Are Intubated Relative to Treatment Group.	0 cm H2O Interval 0.0 to 0.0	0 cm H2O Interval 0.0 to 0.0	0 cm H2O Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Measure	GLS-1027 120 mg n=42 Participants 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.	GLS-1027 360 mg n=46 Participants 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.	Placebo n=44 Participants Three Placebo pills given by mouth once daily Placebo: Placebo looks like GLS-1027
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 Interval 0.0 to 0.0	0 Days intubated PEEP > 5 cm H2O Interval 0.0 to 0.0	0 Days intubated PEEP > 5 cm H2O Interval 0.0 to 0.0

Adverse Events

GLS-1027 120 mg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

GLS-1027 360 mg

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	GLS-1027 120 mg n=42 participants at risk 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.	GLS-1027 360 mg n=46 participants at risk 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.	Placebo n=44 participants at risk Three Placebo pills given by mouth once daily Placebo: Placebo looks like GLS-1027
Nervous system disorders Cerebrovascular accident	0.00% 0/42 • 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.	2.2% 1/46 • Number of events 1 • 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.	0.00% 0/44 • 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.
Nervous system disorders Ischaemic stroke	0.00% 0/42 • 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.	2.2% 1/46 • Number of events 1 • 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.	0.00% 0/44 • 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.
Cardiac disorders Cardiopulmonary failure	2.4% 1/42 • Number of events 1 • 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.	0.00% 0/46 • 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.	0.00% 0/44 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/42 • 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.	2.2% 1/46 • Number of events 1 • 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.	0.00% 0/44 • 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.

Other adverse events

Measure	GLS-1027 120 mg n=42 participants at risk 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.	GLS-1027 360 mg n=46 participants at risk 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.	Placebo n=44 participants at risk Three Placebo pills given by mouth once daily Placebo: Placebo looks like GLS-1027
Infections and infestations Oral Candidiasis	4.8% 2/42 • Number of events 2 • 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.	6.5% 3/46 • Number of events 3 • 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.	2.3% 1/44 • Number of events 1 • 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.

Additional Information

Senior Clinical Operations Associate

GeneOne Life Science

Phone: 6106576351

Email: dkane@genels.us

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place