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Coronavirus Disease

LAEH Formulation Nasal Spray to Reduce Viral Load

Sponsored by Salvacion USA Inc.

About this trial

Last updated 2 years ago

Study ID

SLV-CV19-SPRAY

Status

Completed

Type

Observational [Patient Registry]

Placebo

No

Accepting

18-75 Years
18 to 65 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 4 years ago

What is this trial about?

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).

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status