LAEH Formulation Nasal Spray to Reduce Viral Load

NCT05768113 | Completed

• 1 other identifier: SLV-CV19-SPRAY
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 administered as a nasal spray to reduce viral load from nasal area of subjects with coronavirus disease 2019 (COVID-19).

Conditions

Coronavirus Disease

Outcome Measures

Primary Outcomes (1)

• Enumerating viral load using RT-PCR test.

  Comparison of change in viral load from baseline between the two treatment arms

  6days

Study Arms (2)

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

Eligibility Criteria

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

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

You may qualify if:

• 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%
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Salvacion USA Inc.: lead

Study Sites (1)

Global Clinical Trials, LLC,

Princeton, New Jersey, 08540, United States

Location

Study Officials

• Jorge Amaya P Amaya, MD

  8485 Bird Road, Suite 303, Miami FL 33155

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: March 14, 2023
• Study Start: May 29, 2021
• Primary Completion: October 4, 2021
• Study Completion: January 6, 2022
• Last Updated: March 14, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)