Effects of ethyl lauroyl arginine nasal spray on COVID-19
| ISRCTN | ISRCTN17834262 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17834262 |
| Secondary identifying numbers | 00054373 |
- Submission date
- 23/04/2022
- Registration date
- 26/04/2022
- Last edited
- 26/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
This study will test a formulation, Ethyl Lauroyl Arginate Hydrochloride [LAEH], 0.1% concentration (referred to as the “study product”) formulation in subjects having mild Coronavirus-19 (COVID-19) disease.
The purpose of this study is to compare the effect of study product and placebo (does not have any active ingredient) administered as a nasal spray for reducing viral load levels in nasal areas of mild COVID-19 positive subjects.
Who can participate?
Adults over 18 years, with Covid-19 infection confirmed by RT-PCR test
What does the study involve?
Participants will be randomly allocated to receive Covixyl-V LAEH nasal spray for 6 days or a placebo spray for 6 days.
What are the possible benefits and risks of participating?
The possible benefits to the subjects in the study are reduction in viral load in the nasal passages along with stopping viral transmission/spread to others. This may or may not decrease your symptoms or COVID-19 infection.
If you agree to take part in this study, there may not be a direct medical benefit to you. We hope the information learned from this study will benefit other patients diagnosed with COVID-19 in the future.
There are minimal physical risks and discomfort to you in this study. No blood tests or medical interventions will be performed as part of this research.
The study staff will collect swabs from nasal passages which at times cause some discomfort to you. You may experience discomfort, eyes watering, sneezing, or bleeding.
Where is the study run from?
Miami Lakes Medical Center (USA)
When is the study starting and how long is it expected to run for?
June 2021 to October 2021
Who is funding the study?
Salvacion LLC (USA)
Who is the main contact?
Dr Abdul Gaffar, abdulgaffar535@gmail.com
Contact information
Principal Investigator
8351 catamran crl
Lakewood Ranch
34202
United States of America
| Phone | +1 6096471088 |
|---|---|
| abdulgaffar535@gmail.com |
Study information
| Study design | Interventional double-blind randomized placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | 41622 PIS 15Jun2021.pdf |
| Scientific title | A randomized, double-blind, multicenter study to evaluate the efficacy and safety of ethyl lauroyl arginine hydrochloride (ELAH) formulation administered as a nasal spray to reduce viral load in the nasal area in subjects with coronavirus disease 2019 (COVID-19) |
| Study acronym | ELAH |
| Study hypothesis | To evaluate and compare the safety and efficacy of LAEH nasal spray (0.1% concentration) against a matching placebo nasal spray, administered to reduce viral load from the nasal area of subjects with Coronavirus Disease 2019 (COVID-19). |
| Ethics approval(s) | Approved 28/06/2021, Adverra IRB (6100 Merriweather, suite 600, Columbia MD 20-21044, USA; +1 877-922-4724; no email provided), ref: 00054373 |
| Condition | COVID-19 (SARS-CoV-2 infection) |
| Intervention | Subjects were enrolled after obtaining written informed consent and were screened for eligibility for the study based on inclusion and exclusion criteria. For confirmation of COVID-19, subjects underwent Reverse transcription polymerase chain reaction (RT-PCR) test. Only those subjects who had laboratory-confirmed diagnosis of COVID-19 at the time of screening (Day -3 to 0) using RT-PCR method and who met all eligibility criteria were enrolled. Along with viral load values from RT-PCR test, cycle threshold (CT) value was also included in the laboratory reports. Subjects with COVID-19 were randomized into this study with Covixyl-V LAEH nasal spray and placebo nasal spray. Subjects were randomized in a 1:1 proportion to receive either LAEH formulation or matching placebo twice daily. Subjects were instructed to use the assigned treatment as nasal spray (2 to 3 puffs in each nostril at a time) twice a day from Day 1 to Day 5 and only once in the morning on Day 6. Subjects were instructed to refrain from eating, drinking, or using any nasal gavage at least 30 minutes prior to use of nasal spray. Subjects were also informed that the daily second treatment should be taken approximately 6 hours after the first treatment. The site personnel explained the effective use of the nasal spray in a step-by-step manner and documented the same training in the source documents. The subjects were instructed to record his/her initials and date and time he/she administered the assigned treatment on a daily basis in the subject diary. On Day 6/end of study (EOS), all the subjects took the first treatment (11th dose) at home around 8:00 am and then visited their respective site as instructed. Then the site performed the viral load enumeration using RT PCR test (including CT value) within 3 and 6 hours post last dose (at end of 11th treatment). Group A assessed subjects with COVID-19 who received Covixyl-V LAEH nasal spray for 6 days. Group B assessed subjects with COVID-19 who received placebo nasal spray for 6 days. The site called each subject daily and collected information on Adverse Events (AEs) (if any), concomitant medications, and treatment compliance and completion of subject diary. Adverse Events (AEs) were collected after signing of informed consent through the end of the study. The frequency of assessment was at screening/baseline and on Day 6. RT-PCR testing was performed for confirmation of positive COVID-19 test, and enumerating viral load (including CT value). Vital signs such as blood pressure (BP), heart rate (HR), respiratory rate (RR), Oxygen saturation (SpO2), body temperature were noted and nasal and physical examination was performed. Safety and tolerability of Covixyl-V LAEH nasal spray were assessed by evaluating AEs, serious adverse events (SAEs), vital signs, treatment discontinuation due to AEs, and nasal and physical examinations. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Covixyl-V (ethyl lauroyl arginine hydrochloride [ELAH] nasal spray) |
| Primary outcome measure | 1. Viral load measured using RT-PCR test post treatment (day 6) 2. Number of Covid-19 free subjects measured using RT-PCR test post treatment (day 6) |
| Secondary outcome measures | Safety and tolerability of Covixyl-V LAEH nasal spray were assessed by evaluating AEs, serious adverse events (SAEs), vital signs, treatment discontinuation due to AEs, and nasal and physical examinations using patient records at the end of the study |
| Overall study start date | 28/06/2021 |
| Overall study end date | 04/10/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 30 |
| Participant inclusion criteria | 1. Signed informed consent 2. Confirmed for Covid-19 infection by RT-PCR tests |
| Participant exclusion criteria | 1. Allergy to ELAH 2. Females who were breast feeding or lactating 3. History of severe respiratory infections 4. Have received period Covid treatment 5. Participated in any interventional drug trial in previous 30 days |
| Recruitment start date | 02/08/2021 |
| Recruitment end date | 04/10/2021 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Hialiah
33016
United States of America
Sponsor information
Industry
210 sylvan drive
Englewood Cliff
07632
United States of America
| Phone | +1 6096470807 |
|---|---|
| ywchob@hotmail.com | |
| Website | http://www.covixyl.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 09/10/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Submitted for publication in Plos One |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 15/06/2021 | 26/04/2022 | No | Yes | |
| Preprint results | 10/03/2022 | 09/08/2022 | No | No | |
| Other unpublished results | version 0.1 | 19/11/2021 | 26/08/2022 | No | No |
Additional files
Editorial Notes
26/08/2022: The results (not peer reviewed) have been uploaded as an additional file.
09/08/2022: Preprint results have been added.
05/05/2022: The overall trial end date has been changed from 04/10/2022 to 04/10/2021 and the plain English summary has been updated accordingly.
27/04/2022: The study hypothesis was added.
26/04/2022: Trial's existence confirmed by Advarra IRB
