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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
The Grasses of Eden Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Infection

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    July 21, 2021
    Last Updated
    July 21, 2021
    Sponsor
    The Grasses of Eden Ltd
    Collaborators
    Sherutei Briut Clalit
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    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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