Clinical trial NCT04997395: Feasibility of Cannabidiol for the Treatment of Long COVID
Official title: Safety and Tolerability of Full Spectrum Cannabidiol Dominant Medicinal Cannabis in Treating Symptoms Associated With Long COVID: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Long COVID
Keywords: long COVID
COVID
cannabidiol
post-COVID-19 syndrome
post-COVID syndrome
Lead sponsor: Bod Australia
Sponsor class: INDUSTRY
Collaborators: name: Drug Science, UK
First posted: 2021-08-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label, phase 2 clinical trial to assess the feasibility of a cannabidiol (CBD) dominant medicinal cannabis for the treatment of Long COVID. The primary aim is to assess the feasibility of recruiting and retaining individuals diagnosed with Long COVID into a treatment trial of medicinal cannabis, as well as assessing the safety and tolerability of a dominant medicinal cannabis in this population. The secondary aim is to determine the effect of a CBD dominant medicinal cannabis on symptoms associated with Long COVID.

Detailed description: Long COVID, also defined as post-COVID-19 syndrome, is a common outcome after infection with the SARS-COV-2 virus. The need for treatment and ongoing support for people experiencing Long COVID has been increasingly recognised, including through the establishment of dedicated treatment units within the NHS. While symptoms and their severity may vary greatly between individuals, some of the common symptoms associated with Long COVID include fatigue, breathlessness, pain, sleep disturbances and dysautonomia. In this study, we will test the feasibility of a broad spectrum cannabidiol (CBD) dominant formulation, MediCabilis Cannabis sativa 50, for treating these symptoms in people with a diagnosis of Long COVID. CBD is the primary non-psychoactive ingredient in cannabis, and it is being increasingly used in the treatment of symptoms which are similar to those associated with Long COVID. Additionally, there is some evidence that CBD may be effective in reducing inflammation associated with COVID infection. Together, this evidence suggests that it is possible that CBD may be an effective treatment for people diagnosed with Long COVID. We will therefore conduct a feasibility trial in which 30 people are prescribed CBD dominant medical cannabis. Patients will take this medication daily for a total of 21 weeks (2-week titration period, 18-weeks steady dose, 1-week dose reduction), followed by 3-weeks with no medication. We will collect monthly self-report assessments of common symptoms including breathlessness, fatigue, mood, cognition and pain via a smartphone app, as well as real-time data on heart rate, physical activity and sleep using wearable technology. We will also collect daily self-report assessments of key symptoms (mood, pain, fatigue and breathlessness) via a smartphone app for 7 days per 28 days. Our study will establish whether it is feasible to recruit and retain patients with a diagnosis of Long COVID into a trial of a CBD dominant medical cannabis. We will also monitor whether there are any side effects to assess the safety and tolerability of a CBD dominant medical cannabis. Our results will determine the feasibility of medicinal cannabis in the treatment of Long COVID and whether it is safe to use.

Eligibility criteria: Inclusion Criteria:

1. Male and females aged 18 years old or above.
2. Long COVID diagnosis, confirmed by either GP triage clinic or attendance and assessment by a Long COVID clinic. Self-diagnosed Long COVID will not be included in the study. It is expected that in order to have a coded diagnosis of long Covid, the participant will have undertaken the relevant clinical assessment and investigations as recommended by the NICE guidance on Long COVID. https://www.nice.org.uk/guidance/ng188
3. Females must be non-pregnant, non-lactating.
4. Proficient in English and have internet access and a mobile phone.
5. Stated willingness to comply with all study procedures and availability for the duration of the study.
6. Provision of signed and dated informed consent form.
7. All male and females of childbearing potential must agree to use highly effective contraception from the time of signing informed consent until 3 months (12 weeks) after the treatment has stopped. Participants using systemically acting hormonal contraception for example the oral contraceptive pill or contraceptive implant should use an additional non-hormonal/reliable barrier method of contraception from the time of signing informed consent until 3 months (12 weeks) after the treatment has stopped.

Exclusion Criteria:

1. Self-diagnosed Long COVID without relevant assessment and investigation as per clinical guidelines.
2. Serious ongoing medical and/or psychiatric illnesses/disorders that will require active and variable treatment during the trial period. (this will be assessed from clinical history and GP records)
3. Used cannabinoids or a cannabinoid-based medicine within 3 months prior to study Day 1 and unwillingness to abstain from recreational drug use during the study period.
4. Cannabis dependence or any other drug or alcohol dependence within the past two years.
5. Known hypersensitivity to cannabis-based products or any of the excipients in the study drug.
6. Use of any other investigational products within 30 days of screening day.
7. Use of anti-coagulant drugs such as warfarin.
8. History of attempted suicide, bipolar disorder or schizophrenia.
9. History of chronic liver failure or present history of an abnormal liver function (LFT) blood test within the 3 months prior to recruitment. This should be able to be confirmed during the screening process as all participants should have had a liver function blood test as part of the recommended clinical assessment prior to diagnosing Long COVID. If no liver function test is available within 6 months of screening (which is unlikely), participants will be asked if they would agree to having a screening LFT.
10. History of allergy to tree nuts, with no definite previous coconut exposure.

Primary outcomes:
measure: Recruitment rate
timeFrame: 12 months (48 weeks)
measure: Tolerability for the treatment of long COVID
timeFrame: 6 months (24 weeks)
measure: Number of side effects
timeFrame: 6 months (24 weeks)
Secondary outcomes:
measure: Long COVID symptoms
timeFrame: 5 months (20 weeks)
measure: Fatigue
timeFrame: 5 months (20 weeks)
measure: Self-reported quality of life
timeFrame: 5 months (20 weeks)
measure: Pain score
timeFrame: 5 months (20 weeks)
measure: Mood (anxiety)
timeFrame: 5 months (20 weeks)
measure: Mood (depression)
timeFrame: 5 months (20 weeks)
measure: Sleep quality
timeFrame: 5 months (20 weeks)
measure: Resting heart rate (expressed as average beats per minute)
timeFrame: 5 months (20 weeks)
measure: Activity levels (number of daily steps, distance walked, stairs climbed, active minutes and calories burned)
timeFrame: 5 months (20 weeks)
measure: Oxygen saturation (expressed as percentage saturation)
timeFrame: 5 months (20 weeks)
measure: Daily symptoms
timeFrame: 5 months (20 weeks)
Other outcomes:
Locations:
city: York
country: United Kingdom
facility: Drug Science
Study officials:
affiliation: Steps Neurorehabilitation Unit
name: Elizabeth Iveson
role: PRINCIPAL_INVESTIGATOR
References: