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

Covid19 Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04951349
Study type Interventional
Source Turn Therapeutics
Contact
Status Completed
Phase Phase 2
Start date January 21, 2021
Completion date May 30, 2021
View Details
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