NCT04951349

Safety and Efficacy of Intranasal Application of GX-03 as a Treatment and Prevention for COVID-19.

Phase 2b Clinical Trial to Evaluate the Tolerability and Efficacy in Reducing the Nasal Viral Load of SARS-CoV-2 of Benzalkonium Chloride 0.0065% (GX-03), in the Form of Nasal Ointment, in Patients Infected With COVID -19, and Evaluation of Its Tolerability in Health Care Providers, as a Preventive of Nasal Colonization, Complementary to Personal Protective Equipment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Turn Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Phase 2b clinical trial to evaluate the safety and efficacy of intranasal application of GX-03 as a treatment and prevention for COVID-19.

Detailed description

Phase 2b clinical trial to evaluate the safety and efficacy of intranasal application of GX-03 as a treatment and prevention for COVID-19. Patients hospitalized with a diagnosis of mild to moderate COVID-19 will be evaluated for a period of five days. Participating health care providers will be evaluated for a period of ten days. Swab samples will be collected from the right and left anterior nostrils at the beginning of the study, as well as three times per day in the treatment arm for five days. Swab samples will be collected from the right and left anterior nostrils at the beginning and end of the prevention arm. Samples will be subjected to biomolecular tests and viral cultures to assess positivity and disease progression. Safety will be evaluated through standard measures of erythema and edema in the nasal mucosa.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	GX-03	Same dosage used in Bactroban Nasal studies.
DRUG	Petrolatum ointment	Viscous ointment similar in form to study drug.

Timeline

• Start date: 2021-01-21
• Primary completion: 2021-05-30
• Completion: 2021-05-30
• First posted: 2021-07-06
• Last updated: 2021-07-06

Locations

3 sites across 1 country: Panama

Regulatory

• FDA-regulated drug study