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

COVID-19 Infection Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04974190
• Other study ID #: 0037-21-COM1
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2021
• Est. completion date: February 2022

Study information

• Verified date: July 2021
• Source: The Grasses of Eden Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 550
• Est. completion date: February 2022
• Est. primary completion date: October 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

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

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Related Conditions & MeSH terms

• COVID-19 Infection

Intervention

Device:
• Nasal Spray Device
A Nasal Spray apparatus containing a liquid

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The Grasses of Eden Ltd	Sherutei Briut Clalit

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	First 7 days after testing positive on PCR test
Primary	Symptoms monitoring	Monitoring any disease symptoms reported by patient	First 7 days after testing positive on PCR test