Covid19Phase 2NCT04951349
Safety and Efficacy of Intranasal Application of GX-03 as a Treatment and Prevention for COVID-19.
A Phase 2 study testing GX-03 and Petrolatum ointment in people with Covid19, run by Turn Therapeutics at 3 sites in Panama.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Covid19
- What is being tested?
- GX-03 and Petrolatum ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 3 sitesPanama
- Study dates
- 21 Jan 2021to 30 May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Panama3 sites
Gorgas Memorial Research Hospital
Panama City
Hospital Modular COVID-19
Panama City
Hospital Santo Tomas
Panama City
About this study
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
Phase 2b clinical trial to evaluate the safety and efficacy of intranasal application of GX-03 as a treatment and prevention for COVID-19.
Read the 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
- Being tested
- GX-03, Petrolatum ointment
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GX-03Drug
Also called Hexagen Antimicrobial
Same dosage used in Bactroban Nasal studies.
Petrolatum ointmentDrug
Also called Placebo
Viscous ointment similar in form to study drug.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Petrolatum ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of 60% in viral load from baseline
Time to achieve a 60% reduction in viral load from baseline.
Measured: 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.
Measured: 5-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start21 Jan 2021
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turn Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gorgas Memorial Institute for Health Studies, Hospital Santo Tomas, Hospital Modular - Covid-19
- Responsible party
- Sponsor
- Investigators
- Julio Sandoval, MD, Principal investigator, Medical Corps of Punta Pacifica Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951349
- Sponsor's protocol ID
- GX-03 for COVID-19
- Status last verified
- Jul 2021
- First submitted
- 30 Jun 2021
- Last updated
- 6 Jul 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04951349
- Acronym / sponsor ID
- GX-03 for COVID-19
- Conditions
- Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Turn TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Gorgas Memorial Institute for Health Studies, Hospital Santo Tomas, Hospital Modular - Covid-19
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 6 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment of hospitalized patients with laboratory-confirmed COVID-19 | Experimental | Drug: GX-03Hospitalized patients with laboratory-confirmed COVID-19 using GX-03 administered intranasally TID for 5 days. |
| Placebo Treatment of hospitalized patients with laboratory-confirmed COVID-19 | Placebo comparator | Drug: Petrolatum ointmentHospitalized patients with laboratory-confirmed COVID-19 using placebo (petrolatum emulsion) administered intranasally TID for 5 days. |
| Prevention of SARS-COV-2 in Health Care Providers | Experimental | Drug: GX-03Health 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 | Placebo comparator | Drug: Petrolatum ointmentHealth care providers with laboratory-confirmed negative COVID-19 using placebo (petrolatum emulsion) administered intranasally TID for 10 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GX-03Also: Hexagen AntimicrobialSame dosage used in Bactroban Nasal studies. | Drug | Prevention of SARS-COV-2 in Health Care Providers, Treatment of hospitalized patients with laboratory-confirmed COVID-19 |
| Petrolatum ointmentAlso: PlaceboViscous ointment similar in form to study drug. | Drug | Placebo Prevention of SARS-COV-2 in Health Care Providers, Placebo Treatment of hospitalized patients with laboratory-confirmed COVID-19 |
Primary outcome
Reduction of 60% in viral load from baseline
Time frame: 5 days
Time to achieve a 60% reduction in viral load from baseline.
Primary Safety analysis
Time frame: 5-10 days
To evaluate the incidence rate(s) of non-serious and serious adverse events associated with administration of the study product.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julio Sandoval, MD principal investigator
Medical Corps of Punta Pacifica Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GX-03 and Petrolatum ointment in people with Covid19, run by Turn Therapeutics at 3 sites in Panama.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of 60% in viral load from baseline (time frame: 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021.