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
|
A Nasal Spray apparatus containing a liquid
|
|
PLACEBO_COMPARATOR: Patients treated with actual device with placebo solution
|
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
Collaborators
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.