Covid19Phase 1NCT04686539
Synthetic CBD as a Therapy for COVID-19
A Phase 1 study testing CBD in people with Covid19 and CBD, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The study aim to test proof of concept of CBD treatment for efficacy and safety in patients suffering with mild COVID-19 infection. The CBD will be delivered via oil droplets not containing THC, compared to placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- CBD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Jan 2021to Jan 2022
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COVID 19 patients
- 18 Years and older
Who cannot join
- Respiratory failure requiring mechanical ventilation
- Intensive care unit admission
- Neutrophile con. < 1000 cells/mm3
- Lymphocyte con < 500 cells/mm3
- Liver enzymes 5 times higher then the norm
- QT interval longer then 500 ms.
Show all 9Show fewer
- Pregnancy
- Hemodialysis renal replacement therapy
- Active or prior psychotic event
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center, Tel Hashomer
Ramat Gan, Tel Aviv
Howard Amital, MD, MHA, +972-3-5302638, Howard.amital@sheba.health.gov.il
About this study
Official title: Synthetic CBD Oil Droplets as a Therapy for Mild to Moderate SARS-CoV-2 Infection. Assesment of Efficacy and Safety.
The study aim to test proof of concept of CBD treatment for efficacy and safety in patients suffering with mild COVID-19 infection. The CBD will be delivered via oil droplets not containing THC, compared to placebo.
- Being tested
- CBD, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBDDrug
CBD oil not containing THC, to be administered sub-lingual.
PlaceboDrug
Placebo Oil
| Study group | Role | What they receive |
|---|---|---|
| Recipients of CBD oil | Experimental | Patients receiving Cannabidiol oil drops, administered sublingual, 3 times a day, while hospitalized. Dosing and administration frequency would be assessed bi-daily by the medical staff. Receives: Drug: CBD |
| Recipients of Placebo | Placebo comparator | Patients receiving placebo oil, administered sublingual, 3 times a day, while hospitalized. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical deterioration
Patients chance of clinical deterioration of COVID19 disease as defined by percentage of patients requiring oxygen therapy during their hospitalization.
Measured: 14 days
Secondary outcomes (6)
Changes in NEWS scale
NEWS2- National Early Warning Score - a score defining the probability of severe COVID 19 disease. Minimum score is 0, while maximum score is 23. Higher score means worse outcome
Measured: 14 days
Supportive care therapies
Percentage of patients requiring the respiratory support of either of the following : high flow nasal canula oxygen support, mechanical ventilation or use of extra corporeal membrane oxygenation.
Measured: 14 days
SARS-COV2 presence
Presence of SARS-COV2 in oral \& nasal secretions in days 10, 14 of the study
Measured: 10 days, 14 days
Hospitalization Days
Hospitalization days due to COVID-19
Measured: 14 days
Cytokine Levels
IL2, IL18, IL8. IL6, IL10, TNF-alpha, TGF-beta levels at day 3, day 7 and discharge day (which is on average the 10th day of hospitalization).
All cytokine levels would be measured by pg/mL.
Measured: Day 3, day 7, discharge day (which is on average the 10th day of hospitalization).
Hamilton Anxiety Score
A verified score measuring anxiety. Minimum score is 0, while maximum score is 56. Higher scores mean worse outcome.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start20 Jan 2021
- Primary completionNov 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Howard Amital, Sheba Medical Center
- Investigators
- Howard Amital, MD, MHA, Principal investigator, Head of Internal Medicine ward "B", Sheba Health Center, Tel Hashomer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686539
- Sponsor's protocol ID
- SHEBA-20-7526-HA-CTIL
- Status last verified
- Sep 2021
- First submitted
- 18 Dec 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synthetic CBD Oil Droplets as a Therapy for Mild to Moderate SARS-CoV-2 Infection. Assesment of Efficacy and Safety.
- ClinicalTrials.gov ID
- NCT04686539
- Acronym / sponsor ID
- SHEBA-20-7526-HA-CTIL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 28 Dec 2020 (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.
The study aim to test proof of concept of CBD treatment for efficacy and safety in patients suffering with mild COVID-19 infection. The CBD will be delivered via oil droplets not containing THC, compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recipients of CBD oil | Experimental | Drug: CBDPatients receiving Cannabidiol oil drops, administered sublingual, 3 times a day, while hospitalized. Dosing and administration frequency would be assessed bi-daily by the medical staff. |
| Recipients of Placebo | Placebo comparator | Drug: PlaceboPatients receiving placebo oil, administered sublingual, 3 times a day, while hospitalized. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COVID 19 patients
- 18 Years and older
Key exclusion criteria (9 listed)
- Respiratory failure requiring mechanical ventilation
- Intensive care unit admission
- Neutrophile con. < 1000 cells/mm3
- Lymphocyte con < 500 cells/mm3
- Liver enzymes 5 times higher then the norm
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 |
|---|---|---|
| CBDCBD oil not containing THC, to be administered sub-lingual. | Drug | Recipients of CBD oil |
| PlaceboPlacebo Oil | Drug | Recipients of Placebo |
Primary outcome
Clinical deterioration
Time frame: 14 days
Patients chance of clinical deterioration of COVID19 disease as defined by percentage of patients requiring oxygen therapy during their hospitalization.
6 secondary outcomes
Changes in NEWS scale
Time frame: 14 days
Supportive care therapies
Time frame: 14 days
SARS-COV2 presence
Time frame: 10 days, 14 days
Hospitalization Days
Time frame: 14 days
Cytokine Levels
Time frame: Day 3, day 7, discharge day (which is on average the 10th day of hospitalization).
Hamilton Anxiety Score
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
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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.
Howard Amital, MD, MHA principal investigator
Head of Internal Medicine ward "B", Sheba Health Center, Tel Hashomer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBD in people with Covid19 and CBD, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. 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 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Howard Amital, MD, MHA (+972-3-5302638, Howard.Amital@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical deterioration (time frame: 14 days). 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 28 Sep 2021.