Coronavirus DiseaseNCT05768113
LAEH Formulation Nasal Spray to Reduce Viral Load
An observational study of Coronavirus Disease, run by Salvacion USA Inc. at 1 site in United States.
Trial summary
The Covixyl-V LAEH Nasal Spray's safety and efficay is clinically tested for use in subjects with COVID-19 infection. A randomized, double-blind, multi-center study is conducted to evaluate the efficacy and safety of ethyl lauroyl arginate hydrochloride (LAEH) formulation versus a matching placebo formulation… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coronavirus Disease
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2021to 6 Jan 2022
- How long will I take part?
- 6 Days
- Phase
- Observational
- 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
Study population: In the study, 33 subjects were screened and 3 of them failed in screening tests. Total 30 subjects were enrolled in the study. Out of these 30 enrolled subjects, 15 subjects were randomized to Covixyl-V group and 15 subjects were randomized to placebo group
Who may be able to join
- Ability to provide written informed consent or, by his or her legal/authorized representatives when the subject is not capable of giving consent, prior to initiation of any study procedures
- Male or female of ≥18 years and ≤65 years of age (inclusive) at time of enrollment
- Subjects with laboratory-confirmed diagnosis of COVID-19 at the time of screening (Day -3 to 0) using RT PCR method.
- Subject with mild COVID-19 symptoms (e.g., fever, cough, sore throat, headache, muscle pain, nasal congestion, rhinorrhea, loss of smell and taste) but who did not have shortness of breath or dyspnea
- Subjects who did not require hospitalization
- Subjects with SpO2 levels ≥ 95%
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- Viral load by RT-PCR between 3.3 × 106 copies/mL to 6.6 × 106 copies/mL
- Female subject who was not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile
- Female subject of childbearing potential who had negative urine pregnancy test.
Who cannot join
- Allergy to LAEH or any of the excipients of the formulation
- History of allergies or flu within 30 days prior to the day of enrollment
- Sensitivity to nostril skin or irritation or bleeding history within 30 days prior to the day of enrollment
- Females who were breast-feeding, lactating, pregnant or intending to become pregnant
- COVID-19 subjects with moderate, severe or critical illness or requiring intensive care or mechanical ventilation
- History of severe respiratory disease and requirement for long-term oxygen therapy
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- Had received antibiotic/s, antiviral drug, and hormonal drugs within 30 days prior to the day of enrollment
- Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator
- Had received or had a plan to receive a SARS-CoV-2 vaccine during the study period
- Participated in any interventional drug or medical device trials within 30 days prior to the day of enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Global Clinical Trials, LLC,
Princeton, New Jersey, 08540
About this study
Official title: A Randomized, Double-blind, Multi-center Study to Evaluate the Efficacy and Safety of Ethyl Lauroyl Arginate Hydrochloride (LAEH) Formulation Versus a Matching Placebo Formulation
The Covixyl-V LAEH Nasal Spray's safety and efficay is clinically tested for use in subjects with COVID-19 infection.
A randomized, double-blind, multi-center study is conducted to evaluate the efficacy and safety of ethyl lauroyl arginate hydrochloride (LAEH) formulation versus a matching placebo formulation administered as a nasal spray to reduce viral load from nasal area of subjects with coronavirus disease 2019 (COVID-19).
Read the detailed description
The primary endpoint for this study was the comparison of change in viral load in RT-PCR Test.
Proportion of COVID-19 infection-free subjects between the two treatment arms was followed.
- Conditions
- Coronavirus Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Covixyl-V ELAH | No formal sample size calculation was performed. A total of 30 patients were enrolled and considered as sufficient sample size to compare the estimates of tests treatment with reference treatment | |
| Placebo | No formal sample size calculation was performed. A total of 30 patients were enrolled and considered as sufficient sample size to compare the estimates of tests treatment with reference treatment. This one is Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enumerating viral load using RT-PCR test.
Comparison of change in viral load from baseline between the two treatment arms
Measured: 6days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start29 May 2021
- Primary completion4 Oct 2021
- Study completion6 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 6 Days
Sponsor and investigators
- Lead sponsor
- Salvacion USA Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorge Amaya P Amaya, MD, Principal investigator, 8485 Bird Road, Suite 303, Miami FL 33155
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768113
- Sponsor's protocol ID
- SLV-CV19-SPRAY
- Status last verified
- Jan 2023
- First submitted
- 6 Jan 2023
- Last updated
- 14 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center Study to Evaluate the Efficacy and Safety of Ethyl Lauroyl Arginate Hydrochloride (LAEH) Formulation Versus a Matching Placebo Formulation
- ClinicalTrials.gov ID
- NCT05768113
- Acronym / sponsor ID
- SLV-CV19-SPRAY
- Conditions
- Coronavirus Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Salvacion USA Inc.Industry (pharma, biotech, devices)
- Study start
- 29 May 2021 (actual)
- Primary completion
- 4 Oct 2021 (actual)
- Study completion
- 6 Jan 2022 (actual)
- First posted
- 14 Mar 2023 (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.
The Covixyl-V LAEH Nasal Spray's safety and efficay is clinically tested for use in subjects with COVID-19 infection.
A randomized, double-blind, multi-center study is conducted to evaluate the efficacy and safety of ethyl lauroyl arginate hydrochloride (LAEH) formulation versus a matching placebo formulation administered as a nasal spray to reduce viral load from nasal area of subjects with coronavirus disease 2019 (COVID-19).
Detailed description
The primary endpoint for this study was the comparison of change in viral load in RT-PCR Test.
Proportion of COVID-19 infection-free subjects between the two treatment arms was followed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covixyl-V ELAH | – | –No formal sample size calculation was performed. A total of 30 patients were enrolled and considered as sufficient sample size to compare the estimates of tests treatment with reference treatment |
| Placebo | – | –No formal sample size calculation was performed. A total of 30 patients were enrolled and considered as sufficient sample size to compare the estimates of tests treatment with reference treatment. This one is Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In the study, 33 subjects were screened and 3 of them failed in screening tests. Total 30 subjects were enrolled in the study. Out of these 30 enrolled subjects, 15 subjects were randomized to Covixyl-V group and 15 subjects were randomized to placebo group
Key inclusion criteria (9 listed)
- Ability to provide written informed consent or, by his or her legal/authorized representatives when the subject is not capable of giving consent, prior to initiation of any study procedures
- Male or female of ≥18 years and ≤65 years of age (inclusive) at time of enrollment
- Subjects with laboratory-confirmed diagnosis of COVID-19 at the time of screening (Day -3 to 0) using RT PCR method.
- Subject with mild COVID-19 symptoms (e.g., fever, cough, sore throat, headache, muscle pain, nasal congestion, rhinorrhea, loss of smell and taste) but who did not have shortness of breath or dyspnea
- Subjects who did not require hospitalization
Key exclusion criteria (10 listed)
- Allergy to LAEH or any of the excipients of the formulation
- History of allergies or flu within 30 days prior to the day of enrollment
- Sensitivity to nostril skin or irritation or bleeding history within 30 days prior to the day of enrollment
- Females who were breast-feeding, lactating, pregnant or intending to become pregnant
- COVID-19 subjects with moderate, severe or critical illness or requiring intensive care or mechanical ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Enumerating viral load using RT-PCR test.
Time frame: 6days
Comparison of change in viral load from baseline between the two treatment arms
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 14 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Jorge Amaya P Amaya, MD principal investigator
8485 Bird Road, Suite 303, Miami FL 33155
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Disease, run by Salvacion USA Inc. at 1 site in United States.
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 9 inclusion and 10 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 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Enumerating viral load using RT-PCR test. (time frame: 6days). 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 14 Mar 2023.