COVID-19 InfectionNCT04974190
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
A study testing Nasal Spray Device in people with COVID-19 Infection, run by The Grasses of Eden Ltd.
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 Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- Nasal Spray Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 550 participants
- Where
- No sites listed yet
- Study dates
- Aug 2021to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Inclusion Criteria: Having tested positive to Covid-19 on PCR test -
Exclusion Criteria: Pregnancy Low blood pressure On immune system suppressing medications
-
About this study
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
Read the 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
- Conditions
- COVID-19 Infection
- Being tested
- Nasal Spray Device
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Spray DeviceDevice
A Nasal Spray apparatus containing a liquid
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with actual device with actual solution | Active comparator | Not described Receives: Device: Nasal Spray Device |
| Patients treated with actual device with placebo solution | Placebo comparator | Not described Receives: Device: Nasal Spray Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: First 7 days after testing positive on PCR test
Symptoms monitoring
Monitoring any disease symptoms reported by patient
Measured: First 7 days after testing positive on PCR test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study startAug 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A control group is allocated a placebo solution
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Grasses of Eden Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sherutei Briut Clalit
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974190
- Sponsor's protocol ID
- 0037-21-COM1
- Status last verified
- Jul 2021
- First submitted
- 21 Jul 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04974190
- Acronym / sponsor ID
- 0037-21-COM1
- Conditions
- COVID-19 Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- The Grasses of Eden LtdIndustry (pharma, biotech, devices)
- Collaborators
- Sherutei Briut Clalit
- Study start
- Aug 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A control group is allocated a placebo solution
| Arm | Type | Receives |
|---|---|---|
| Patients treated with actual device with actual solution | Active comparator | Device: Nasal Spray Device |
| Patients treated with actual device with placebo solution | Placebo comparator | Device: Nasal Spray Device |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal Spray DeviceA Nasal Spray apparatus containing a liquid | Device | Patients treated with actual device with actual solution, Patients treated with actual device with placebo solution |
Primary outcome
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
Symptoms monitoring
Time frame: First 7 days after testing positive on PCR test
Monitoring any disease symptoms reported by patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal Spray Device in people with COVID-19 Infection, run by The Grasses of Eden Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.