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
Primary Purpose
COVID-19 Infection
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nasal Spray Device
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Infection
Eligibility Criteria
Inclusion Criteria: Having tested positive to Covid-19 on PCR test -
Exclusion Criteria: Pregnancy Low blood pressure On immune system suppressing medications
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Patients treated with actual device with actual solution
Patients treated with actual device with placebo solution
Arm Description
Outcomes
Primary Outcome Measures
Covid-19 infection self-testing on days 2, 4 following testing positive on PCR test
Testing using a self testing kit of the Quidel QuickView type
Symptoms monitoring
Monitoring any disease symptoms reported by patient
Secondary Outcome Measures
Full Information
NCT ID
NCT04974190
First Posted
July 21, 2021
Last Updated
July 21, 2021
Sponsor
The Grasses of Eden Ltd
Collaborators
Sherutei Briut Clalit
1. Study Identification
Unique Protocol Identification Number
NCT04974190
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2021 (Anticipated)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
February 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Grasses of Eden Ltd
Collaborators
Sherutei Briut Clalit
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A control group is allocated a placebo solution
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
550 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients treated with actual device with actual solution
Arm Type
Active Comparator
Arm Title
Patients treated with actual device with placebo solution
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Nasal Spray Device
Intervention Description
A Nasal Spray apparatus containing a liquid
Primary Outcome Measure Information:
Title
Covid-19 infection self-testing on days 2, 4 following testing positive on PCR test
Description
Testing using a self testing kit of the Quidel QuickView type
Time Frame
First 7 days after testing positive on PCR test
Title
Symptoms monitoring
Description
Monitoring any disease symptoms reported by patient
Time Frame
First 7 days after testing positive on PCR test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Having tested positive to Covid-19 on PCR test -
Exclusion Criteria: Pregnancy Low blood pressure On immune system suppressing medications
-
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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