Infection, SARS-CoV 2
Conditions
Keywords
COVID-19
Brief summary
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.
Detailed description
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.
Interventions
DRUGGLS-1200
GLS-1200 is given as a nasal spray using an atomizer
DRUGPlacebo
Placebo is given as a nasal spray using an atomizer
Sponsors
GeneOne Life Science, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 or older * Able to provide informed consent * Able and willing to comply with study procedures * Able and willing to utilize an approved form of pregnancy prevention for women of child bearing potential through to the end of treatment
Exclusion criteria
* Know allergy to quinine, quinidine, or mefloquine * Confirmed prior positive test for SARS-CoV-2 * Treatment within the past 2 weeks with chloroquine, hydroxychloroquine, or remdesivir * Pregnancy or documentation of pregnancy by pre-treatment urine test or breast feeding or plans to become pregnant during the course of the study
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GLS-1200 1 mL of GLS-1200 per nostril, TID
GLS-1200: GLS-1200 is given as a nasal spray using an atomizer | 123 |
| 0.9 %Saline 1 mL of 0.9% Saline per nostril, TID
Placebo: Placebo is given as a nasal spray using an atomizer | 61 |
| Total | 184 |
Baseline characteristics
| Characteristic | GLS-1200 | 0.9 %Saline | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 3 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 109 Participants | 58 Participants | 167 Participants |
| Age, Continuous | 45.1 years STANDARD_DEVIATION 13.81 | 41.3 years STANDARD_DEVIATION 12.99 | 43.9 years STANDARD_DEVIATION 13.63 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 3 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 118 Participants | 58 Participants | 176 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 38 Participants | 19 Participants | 57 Participants |
| Race (NIH/OMB) White | 79 Participants | 33 Participants | 112 Participants |
| Region of Enrollment United States | 123 participants | 61 participants | 184 participants |
| Sex: Female, Male Female | 81 Participants | 40 Participants | 121 Participants |
| Sex: Female, Male Male | 42 Participants | 21 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 123 | 0 / 61 |
| other Total, other adverse events | 41 / 123 | 21 / 61 |
| serious Total, serious adverse events | 0 / 123 | 0 / 61 |
Outcome results
Primary
Incidence of SARS-CoV-2 Infection, Confirmed by PCR Relative to Treatment Group
Time frame: Through 4 weeks of treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GLS-1200 | Incidence of SARS-CoV-2 Infection, Confirmed by PCR Relative to Treatment Group | 0 Participants |
| 0.9 %Saline | Incidence of SARS-CoV-2 Infection, Confirmed by PCR Relative to Treatment Group | 0 Participants |
Primary
Number Serious Adverse Events as Assessed by CTCAE v5.0
Time frame: Through 4 weeks of treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GLS-1200 | Number Serious Adverse Events as Assessed by CTCAE v5.0 | 0 Participants |
| 0.9 %Saline | Number Serious Adverse Events as Assessed by CTCAE v5.0 | 0 Participants |