Clinical trial NCT05768113: LAEH Formulation Nasal Spray to Reduce Viral Load
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Disease
Lead sponsor: Salvacion USA Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

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.

Eligibility criteria: Inclusion Criteria:

1. 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
2. Male or female of ≥18 years and ≤65 years of age (inclusive) at time of enrollment
3. Subjects with laboratory-confirmed diagnosis of COVID-19 at the time of screening (Day -3 to 0) using RT PCR method.
4. 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
5. Subjects who did not require hospitalization
6. Subjects with SpO2 levels ≥ 95%
7. Viral load by RT-PCR between 3.3 × 106 copies/mL to 6.6 × 106 copies/mL
8. Female subject who was not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile
9. Female subject of childbearing potential who had negative urine pregnancy test.

Exclusion Criteria:

1. Allergy to LAEH or any of the excipients of the formulation
2. History of allergies or flu within 30 days prior to the day of enrollment
3. Sensitivity to nostril skin or irritation or bleeding history within 30 days prior to the day of enrollment
4. Females who were breast-feeding, lactating, pregnant or intending to become pregnant
5. COVID-19 subjects with moderate, severe or critical illness or requiring intensive care or mechanical ventilation
6. History of severe respiratory disease and requirement for long-term oxygen therapy
7. Had received antibiotic/s, antiviral drug, and hormonal drugs within 30 days prior to the day of enrollment
8. 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
9. Had received or had a plan to receive a SARS-CoV-2 vaccine during the study period
10. Participated in any interventional drug or medical device trials within 30 days prior to the day of enrollment.

Primary outcomes:
measure: Enumerating viral load using RT-PCR test.
timeFrame: 6days
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Global Clinical Trials, LLC,
state: New Jersey
Study officials:
affiliation: 8485 Bird Road, Suite 303, Miami FL 33155
name: Jorge Amaya P Amaya, MD
role: PRINCIPAL_INVESTIGATOR
References: