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No longer enrolling
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This clinical trial will evaluate the safety, tolerability and effectiveness of topical GLS-1200 nasal spray to reduce the incidence of confirmed, symptomatic SARS-CoV-2 infection.
This Phase II randomized, placebo-controlled, double-blind study will assess whether topical GLS-1200 applied via nasal spray atomizer is well-tolerated and can reduce the incidence of confirmed SARS-CoV-2 infection. Subjects will be randomized to either the GLS-1200 or placebo group in a 2:1 ratio with a target enrollment of 225 subjects. Subjects will self-administer study drug three times daily for 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLS-1200 | Experimental | 1 mL of GLS-1200 per nostril, TID |
|
| 0.9 %Saline | Placebo Comparator | 1 mL of 0.9% Saline per nostril, TID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLS-1200 | Drug | GLS-1200 is given as a nasal spray using an atomizer |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number Serious Adverse Events as Assessed by CTCAE v5.0 | Through 4 weeks of treatment | |
| Incidence of SARS-CoV-2 Infection, Confirmed by PCR Relative to Treatment Group | Through 4 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sinus and Nasal Specialists of Louisiana | Baton Rouge | Louisiana | 70809 | United States | ||
| University of Pennsylvania |
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| ID | Title | Description |
|---|---|---|
| FG000 | GLS-1200 | 1 mL of GLS-1200 per nostril, TID GLS-1200: GLS-1200 is given as a nasal spray using an atomizer |
| FG001 | 0.9 %Saline | 1 mL of 0.9% Saline per nostril, TID Placebo: Placebo is given as a nasal spray using an atomizer |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GLS-1200 | 1 mL of GLS-1200 per nostril, TID GLS-1200: GLS-1200 is given as a nasal spray using an atomizer |
| BG001 | 0.9 %Saline | 1 mL of 0.9% Saline per nostril, TID Placebo: Placebo is given as a nasal spray using an atomizer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number Serious Adverse Events as Assessed by CTCAE v5.0 | Posted | Count of Participants | Participants | Through 4 weeks of treatment |
|
|
Adverse events were collected from the time of consent through 4 weeks of treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GLS-1200 | 1 mL of GLS-1200 per nostril, TID GLS-1200: GLS-1200 is given as a nasal spray using an atomizer |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Clinical Operations Associate | GeneOne Life Science | 6106576351 | dkane@genels.us |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 26, 2021 | Jul 2, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 21, 2022 | Jul 15, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D014777 | Virus Diseases |
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| Placebo |
| Drug |
Placebo is given as a nasal spray using an atomizer |
|
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Conroe Willis Medical Reasearch | Conroe | Texas | 77304 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Incidence of SARS-CoV-2 Infection, Confirmed by PCR Relative to Treatment Group | Posted | Count of Participants | Participants | Through 4 weeks of treatment |
|
|
|
| 0 |
| 123 |
| 0 |
| 123 |
| 41 |
| 123 |
| EG001 | 0.9 %Saline | 1 mL of 0.9% Saline per nostril, TID Placebo: Placebo is given as a nasal spray using an atomizer | 0 | 61 | 0 | 61 | 21 | 61 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
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| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |