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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Covid19

Intervention / Treatment
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* Drug: GX-03
* Drug: Petrolatum ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Patients aged 18-65 hospitalized with SARS-CoV-2, diagnosed by a positive nasal or nasopharyngeal swab 2. Men or women who are not pregnant, not breastfeeding, postmenopausal, naturally or surgically sterile, or who agree to use effective contraception during the course of the study. A postmenopausal patient is defined as at least 12 12 months of natural spontaneous amenorrhea or at least 6 weeks after surgical menopause (bilateral oophorectomy). 3. Women of childbearing age who use one of the following acceptable contraceptive methods can be included in the study: Surgical sterilization (hysterectomy and/or bilateral oophorectomy); Surgical sterilization (surgical bilateral tubal ligation at least 6 weeks prior to screening); Intrauterine device (IUD) placed at least 3 months prior to detection; Abstinence (not having heterosexual sex); Barrier method (condom or diaphragm) with spermicide for at least 14 days before selection and until completion of the study; Stable hormonal contraceptive for at least 3 months prior to selection and until completion of the study 4. Patients capable of understanding and providing signed informed consent. Exclusion Criteria: SARS-CoV-2 positive patients on a ventilator. Patients with any open wounds, injuries, inflammation, erythema, or infection (other than COVID-19) affecting the nasal passages, nose, upper lip, and the area of skin around the nose, including herpes simplex lesions. Patients with a history of abnormal bleeding, bruising, frequent nosebleeds, or those diagnosed with von Willebrand disease. Patients with nasal polyps or significant anatomical nasal abnormalities. Patients with a history of nasal surgery, including cauterization, in the last 6 months. Patients who currently have or have ever had a nose or septum piercing Patients treated with antiviral medications in the past 7 days Known allergy or history of significant adverse reactions to benzalkonium chloride or related compounds, or to any of the excipients. Known or suspected pregnancy, pregnancy planned during the study period, or breastfeeding. Clinically significant mental illness (to be determined by the investigator) Recent history of (last 12 months) or strong potential for alcohol or substance abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink = 12 oz of beer, 5.0 oz of wine, or 1.5 oz of distilled spirits) Exposure to any agents being researched within 30 days prior to admission to the study. Prior enrollment in this study If the patient has a condition that the investigator believes would interfere with their ability to give informed consent or comply with study instructions, or that could confuse the interpretation of study results or put the patient at undue risk.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two part study with four total arms. Parts: Health care providers and CV-19 infected patients. Arms: Interventional and placebo in each of the two groups.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment of hospitalized patients with laboratory-confirmed COVID-19<br>Hospitalized patients with laboratory-confirmed COVID-19 using GX-03 administered intranasally TID for 5 days. | Drug: GX-03<br>* Same dosage used in Bactroban Nasal studies.<br>* Other names: Hexagen Antimicrobial;|
| Placebo Comparator: Placebo Treatment of hospitalized patients with laboratory-confirmed COVID-19<br>Hospitalized patients with laboratory-confirmed COVID-19 using placebo (petrolatum emulsion) administered intranasally TID for 5 days. | Drug: Petrolatum ointment<br>* Viscous ointment similar in form to study drug.<br>* Other names: Placebo;|
| Experimental: Prevention of SARS-COV-2 in Health Care Providers<br>Health care providers with laboratory-confirmed negative COVID-19 using GX-03 administered intranasally TID for 10 days. | Drug: GX-03<br>* Same dosage used in Bactroban Nasal studies.<br>* Other names: Hexagen Antimicrobial;|
| Placebo Comparator: Placebo Prevention of SARS-COV-2 in Health Care Providers<br>Health care providers with laboratory-confirmed negative COVID-19 using placebo (petrolatum emulsion) administered intranasally TID for 10 days. | Drug: Petrolatum ointment<br>* Viscous ointment similar in form to study drug.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of 60% in viral load from baseline | Time to achieve a 60% reduction in viral load from baseline. | 5 days | 
| Primary Safety analysis | To evaluate the incidence rate(s) of non-serious and serious adverse events associated with administration of the study product. | 5-10 days |