A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy of Lavandula Angustifolia Containing Nasal Spray Medical Device in Preventing Deterioration of COVID-19 in Symptomatic Patients

Sponsor

The Grasses of Eden Ltd (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04974190

Collaborator

Sherutei Briut Clalit (Other)

550

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

A Nasal Spray device containing Dead Sea minerals and plant extracts, used to shorten duration and mitigate effects of Covid-19 infection in mild to moderate adult patients

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Infection	Device: Nasal Spray Device	N/A

Detailed Description

A Nasal Spray device containing Dead Sea minerals and plant extracts, designed to incur a PPAR-alpha agonistic effect, used to shorten duration and mitigate effects of Covid-19 infection in mild to moderate adult patients

Study Design

Study Type:

Interventional

Anticipated Enrollment :

550 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A control group is allocated a placebo solutionA control group is allocated a placebo solution

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy of Lavandula Angustifolia Containing Nasal Spray Medical Device in Preventing Deterioration of COVID-19 in Symptomatic Patients

Anticipated Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Patients treated with actual device with actual solution	Device: Nasal Spray Device A Nasal Spray apparatus containing a liquid
Placebo Comparator: Patients treated with actual device with placebo solution	Device: Nasal Spray Device A Nasal Spray apparatus containing a liquid

Arm

Intervention/Treatment

Active Comparator: Patients treated with actual device with actual solution

Device: Nasal Spray Device

A Nasal Spray apparatus containing a liquid

Placebo Comparator: Patients treated with actual device with placebo solution

Device: Nasal Spray Device

A Nasal Spray apparatus containing a liquid

Outcome Measures

Primary Outcome Measures

Covid-19 infection self-testing on days 2, 4 following testing positive on PCR test [First 7 days after testing positive on PCR test]
Testing using a self testing kit of the Quidel QuickView type
Symptoms monitoring [First 7 days after testing positive on PCR test]
Monitoring any disease symptoms reported by patient

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria: Having tested positive to Covid-19 on PCR test -

Exclusion Criteria: Pregnancy Low blood pressure On immune system suppressing medications

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The Grasses of Eden Ltd
Sherutei Briut Clalit

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Grasses of Eden Ltd

ClinicalTrials.gov Identifier:

NCT04974190

Other Study ID Numbers:

0037-21-COM1

First Posted:

Jul 23, 2021

Last Update Posted:

Jul 23, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jul 23, 2021