Trial Outcomes & Findings for GLS-1200 Topical Nasal Spray to Prevent SARS-CoV-2 Infection (COVID-19) (NCT NCT04408183)

NCT ID: NCT04408183

Last Updated: 2025-07-31

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 184 participants
• Primary outcome timeframe: Through 4 weeks of treatment
• Results posted on: 2025-07-31

Participant Flow

Participant milestones

Measure	GLS-1200 1 mL of GLS-1200 per nostril, TID GLS-1200: GLS-1200 is given as a nasal spray using an atomizer	0.9 %Saline 1 mL of 0.9% Saline per nostril, TID Placebo: Placebo is given as a nasal spray using an atomizer
Overall Study STARTED	123	61
Overall Study COMPLETED	112	59
Overall Study NOT COMPLETED	11	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

GLS-1200 Topical Nasal Spray to Prevent SARS-CoV-2 Infection (COVID-19)

Baseline characteristics by cohort

Measure	GLS-1200 n=123 Participants 1 mL of GLS-1200 per nostril, TID GLS-1200: GLS-1200 is given as a nasal spray using an atomizer	0.9 %Saline n=61 Participants 1 mL of 0.9% Saline per nostril, TID Placebo: Placebo is given as a nasal spray using an atomizer	Total n=184 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
Age, Categorical Between 18 and 65 years	109 Participants n=5 Participants	58 Participants n=7 Participants	167 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	3 Participants n=7 Participants	17 Participants n=5 Participants
Age, Continuous	45.1 years STANDARD_DEVIATION 13.81 • n=5 Participants	41.3 years STANDARD_DEVIATION 12.99 • n=7 Participants	43.9 years STANDARD_DEVIATION 13.63 • n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	40 Participants n=7 Participants	121 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	21 Participants n=7 Participants	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	118 Participants n=5 Participants	58 Participants n=7 Participants	176 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	79 Participants n=5 Participants	33 Participants n=7 Participants	112 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	38 Participants n=5 Participants	19 Participants n=7 Participants	57 Participants n=5 Participants
Region of Enrollment United States	123 participants n=5 Participants	61 participants n=7 Participants	184 participants n=5 Participants

PRIMARY outcome

Timeframe: Through 4 weeks of treatment

Outcome measures

Measure	GLS-1200 n=123 Participants 1 mL of GLS-1200 per nostril, TID GLS-1200: GLS-1200 is given as a nasal spray using an atomizer	0.9 %Saline n=61 Participants 1 mL of 0.9% Saline per nostril, TID Placebo: Placebo is given as a nasal spray using an atomizer
Number Serious Adverse Events as Assessed by CTCAE v5.0	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Through 4 weeks of treatment

Outcome measures

Measure	GLS-1200 n=123 Participants 1 mL of GLS-1200 per nostril, TID GLS-1200: GLS-1200 is given as a nasal spray using an atomizer	0.9 %Saline n=61 Participants 1 mL of 0.9% Saline per nostril, TID Placebo: Placebo is given as a nasal spray using an atomizer
Incidence of SARS-CoV-2 Infection, Confirmed by PCR Relative to Treatment Group	0 Participants	0 Participants

Adverse Events

GLS-1200

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

0.9 %Saline

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	GLS-1200 n=123 participants at risk 1 mL of GLS-1200 per nostril, TID GLS-1200: GLS-1200 is given as a nasal spray using an atomizer	0.9 %Saline n=61 participants at risk 1 mL of 0.9% Saline per nostril, TID Placebo: Placebo is given as a nasal spray using an atomizer
Respiratory, thoracic and mediastinal disorders Nasal discomfort	9.8% 12/123 • Number of events 12 • Adverse events were collected from the time of consent through 4 weeks of treatment.	9.8% 6/61 • Number of events 6 • Adverse events were collected from the time of consent through 4 weeks of treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.1% 10/123 • Number of events 10 • Adverse events were collected from the time of consent through 4 weeks of treatment.	8.2% 5/61 • Number of events 5 • Adverse events were collected from the time of consent through 4 weeks of treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	7.3% 9/123 • Number of events 9 • Adverse events were collected from the time of consent through 4 weeks of treatment.	8.2% 5/61 • Number of events 5 • Adverse events were collected from the time of consent through 4 weeks of treatment.
Nervous system disorders Headache	8.1% 10/123 • Number of events 10 • Adverse events were collected from the time of consent through 4 weeks of treatment.	8.2% 5/61 • Number of events 5 • Adverse events were collected from the time of consent through 4 weeks of treatment.

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