LAEH Formulation Nasal Spray to Reduce Viral Load

NCT ID: NCT05768113

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-29
• Study Completion Date: 2022-01-06

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.

Conditions

Coronavirus Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Salvacion USA Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorge Amaya P Amaya, MD

Role: PRINCIPAL_INVESTIGATOR

8485 Bird Road, Suite 303, Miami FL 33155

Locations

Global Clinical Trials, LLC,

Princeton, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SLV-CV19-SPRAY

Identifier Type: -

Identifier Source: org_study_id