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

NCT04951349 | Completed Phase 2 FDA Drug

• 1 other identifier: GX-03 for COVID-19
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 3

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Treatment of hospitalized patients with laboratory-confirmed COVID-19

EXPERIMENTAL

Hospitalized patients with laboratory-confirmed COVID-19 using GX-03 administered intranasally TID for 5 days.

Drug: GX-03

Placebo Treatment of hospitalized patients with laboratory-confirmed COVID-19

PLACEBO COMPARATOR

Hospitalized patients with laboratory-confirmed COVID-19 using placebo (petrolatum emulsion) administered intranasally TID for 5 days.

Drug: Petrolatum ointment

Prevention of SARS-COV-2 in Health Care Providers

EXPERIMENTAL

Health care providers with laboratory-confirmed negative COVID-19 using GX-03 administered intranasally TID for 10 days.

Drug: GX-03

Placebo Prevention of SARS-COV-2 in Health Care Providers

PLACEBO COMPARATOR

Health care providers with laboratory-confirmed negative COVID-19 using placebo (petrolatum emulsion) administered intranasally TID for 10 days.

Drug: Petrolatum ointment

Interventions

GX-03 DRUG

Same dosage used in Bactroban Nasal studies.

Also known as: Hexagen Antimicrobial

Prevention of SARS-COV-2 in Health Care Providers; Treatment of hospitalized patients with laboratory-confirmed COVID-19

Petrolatum ointment DRUG

Viscous ointment similar in form to study drug.

Also known as: Placebo

Placebo Prevention of SARS-COV-2 in Health Care Providers; Placebo Treatment of hospitalized patients with laboratory-confirmed COVID-19

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients aged 18-65 hospitalized with SARS-CoV-2, diagnosed by a positive nasal or nasopharyngeal swab
• \. 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).
• \. 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
• \. Patients capable of understanding and providing signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Turn Therapeutics: lead
• Gorgas Memorial Institute for Health Studies: collaborator
• Hospital Santo Tomas: collaborator
• Hospital Modular - Covid-19: collaborator

Study Sites (3)

Gorgas Memorial Research Hospital

Panama City, Panama

Location

Hospital Modular COVID-19

Panama City, Panama

Location

Hospital Santo Tomas

Panama City, Panama

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Julio Sandoval, MD

  Medical Corps of Punta Pacifica Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 6, 2021
• Study Start: January 21, 2021
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: July 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Within 30 days of announcement of study completion.
• Access Criteria: By official request for qualified use.

Locations

PA (3)