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

July 21, 2021 updated by: The Grasses of Eden Ltd
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

550

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Grasses of Eden Ltd

Collaborators

Sherutei Briut Clalit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2021

Primary Completion (ANTICIPATED)

October 1, 2021

Study Completion (ANTICIPATED)

February 1, 2022

Study Registration Dates

First Submitted

July 21, 2021

First Submitted That Met QC Criteria

July 21, 2021

First Posted (ACTUAL)

July 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0037-21-COM1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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