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

Phase 2

Completed

• Conditions: Covid19
• Interventions: Drug: GX-03; Drug: Petrolatum ointment

• Registration Number: NCT04951349
• Lead Sponsor: Turn Therapeutics

Brief 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.

Study Timeline

• Study Start: 2021-01-21
• Primary Completion: 2021-05-30
• Study Completion: 2021-05-30
• Study First Submitted: 2021-06-30
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-01
• Last Update Submitted: 2021-07-01
• Study First Posted: 2021-07-06
• Last Update Posted: 2021-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

1. SARS-CoV-2 positive patients on a ventilator.
2. 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.
3. Patients with a history of abnormal bleeding, bruising, frequent nosebleeds, or those diagnosed with von Willebrand disease.
4. Patients with nasal polyps or significant anatomical nasal abnormalities.
5. Patients with a history of nasal surgery, including cauterization, in the last 6 months.
6. Patients who currently have or have ever had a nose or septum piercing
7. Patients treated with antiviral medications in the past 7 days
8. Known allergy or history of significant adverse reactions to benzalkonium chloride or related compounds, or to any of the excipients.
9. Known or suspected pregnancy, pregnancy planned during the study period, or breastfeeding.
10. Clinically significant mental illness (to be determined by the investigator)
11. 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)
12. Exposure to any agents being researched within 30 days prior to admission to the study.
13. Prior enrollment in this study
14. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prevention of SARS-COV-2 in Health Care Providers	GX-03	Health care providers with laboratory-confirmed negative COVID-19 using GX-03 administered intranasally TID for 10 days.
Placebo Prevention of SARS-COV-2 in Health Care Providers	Petrolatum ointment	Health care providers with laboratory-confirmed negative COVID-19 using placebo (petrolatum emulsion) administered intranasally TID for 10 days.
Placebo Treatment of hospitalized patients with laboratory-confirmed COVID-19	Petrolatum ointment	Hospitalized patients with laboratory-confirmed COVID-19 using placebo (petrolatum emulsion) administered intranasally TID for 5 days.
Treatment of hospitalized patients with laboratory-confirmed COVID-19	GX-03	Hospitalized patients with laboratory-confirmed COVID-19 using GX-03 administered intranasally TID for 5 days.

Primary Outcome Measures

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

Trial Locations

Locations (3)

Gorgas Memorial Research Hospital; 🇵🇦 Panama City, Panama

Hospital Modular COVID-19; 🇵🇦 Panama City, Panama

Hospital Santo Tomas; 🇵🇦 Panama City, Panama