LAEH Formulation Nasal Spray to Reduce Viral Load

Coronavirus Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05768113
• Other study ID #: SLV-CV19-SPRAY
• Status: Completed
• Start date: May 29, 2021
• Est. completion date: January 6, 2022

Study information

• Verified date: January 2023
• Source: Salvacion USA Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 6, 2022
• Est. primary completion date: October 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Disease
• Coronavirus Infections

Locations

Country	Name	City	State
United States	Global Clinical Trials, LLC,	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Salvacion USA Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enumerating viral load using RT-PCR test.	Comparison of change in viral load from baseline between the two treatment arms	6days