SARS-CoV 2Phase 2NCT04408183
GLS-1200 Topical Nasal Spray to Prevent SARS-CoV-2 Infection (COVID-19)
A Phase 2 study testing GLS-1200 in people with SARS-CoV 2 and Infection, run by GeneOne Life Science, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV 2, Infection
- What is being tested?
- GLS-1200
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Jun 2020to 10 Jan 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Sinus and Nasal Specialists of Louisiana
Baton Rouge, Louisiana, 70809
Conroe Willis Medical Reasearch
Conroe, Texas, 77304
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Efficacy, Safety, and Tolerability of GLS-1200 Topical Nasal Spray in the Prevention of Incident Confirmed, Symptomatic SARS-CoV-2 Infection
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.
Read the 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.
- Conditions
- SARS-CoV 2, Infection
- Being tested
- GLS-1200, Placebo
- Keywords
- COVID-19
- Medical subject headings
- Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLS-1200Drug
GLS-1200 is given as a nasal spray using an atomizer
PlaceboDrug
Placebo is given as a nasal spray using an atomizer
| Study group | Role | What they receive |
|---|---|---|
| GLS-1200 | Experimental | 1 mL of GLS-1200 per nostril, TID Receives: Drug: GLS-1200 |
| 0.9 %Saline | Placebo comparator | 1 mL of 0.9% Saline per nostril, TID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Serious Adverse Events as Assessed by CTCAE v5.0
Measured: Through 4 weeks of treatment
Incidence of SARS-CoV-2 Infection, Confirmed by PCR Relative to Treatment Group
Measured: Through 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start10 Jun 2020
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
Why it stopped: No longer enrolling
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 SARS-CoV 2Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 184 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
- NCT04408183
- Sponsor's protocol ID
- T2R-002
- Status last verified
- Jul 2025
- First submitted
- 22 May 2020
- Last updated
- 31 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety, and Tolerability of GLS-1200 Topical Nasal Spray in the Prevention of Incident Confirmed, Symptomatic SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04408183
- Acronym / sponsor ID
- T2R-002
- Conditions
- SARS-CoV 2, Infection
- Keywords
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No longer enrolling
- Enrolment
- 184 participants (actual)
- Lead sponsor
- GeneOne Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Posted 31 Jul 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLS-1200 | Experimental | Drug: GLS-12001 mL of GLS-1200 per nostril, TID |
| 0.9 %Saline | Placebo comparator | Drug: Placebo1 mL of 0.9% Saline per nostril, TID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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-1200GLS-1200 is given as a nasal spray using an atomizer | Drug | GLS-1200 |
| PlaceboPlacebo is given as a nasal spray using an atomizer | Drug | 0.9 %Saline |
Primary outcome
Number Serious Adverse Events as Assessed by CTCAE v5.0
Time frame: Through 4 weeks of treatment
Incidence of SARS-CoV-2 Infection, Confirmed by PCR Relative to Treatment Group
Time frame: Through 4 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GLS-1200 in people with SARS-CoV 2 and Infection, run by GeneOne Life Science, Inc. at 3 sites in United States.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 31 Jul 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 Serious Adverse Events as Assessed by CTCAE v5.0 (time frame: Through 4 weeks of treatment). 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 31 Jul 2025.