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
1 other identifier
interventional
550
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2021
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2021
CompletedFirst Posted
Study publicly available on registry
July 23, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedJuly 23, 2021
July 1, 2021
2 months
July 21, 2021
July 21, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
Symptoms monitoring
Monitoring any disease symptoms reported by patient
First 7 days after testing positive on PCR test
Study Arms (2)
Patients treated with actual device with actual solution
ACTIVE COMPARATORPatients treated with actual device with placebo solution
PLACEBO COMPARATORInterventions
A Nasal Spray apparatus containing a liquid
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Grasses of Eden Ltdlead
- Sherutei Briut Clalitcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2021
First Posted
July 23, 2021
Study Start
August 1, 2021
Primary Completion
October 1, 2021
Study Completion
February 1, 2022
Last Updated
July 23, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share