Feasibility of Cannabidiol for the Treatment of Long COVID

• Status: Not yet recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Long COVID is a common outcome after infection with the SARS-COV-2 virus and 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 and sleep disturbances. In this study we will test the feasibility of a broad spectrum cannabidiol dominant formulation (Medicabilis) for treating these symptoms in people with a diagnosis of long COVID. Cannabidiol (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 cannabidiol 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 five months. We will collect monthly self-report assessments of common symptoms including breathlessness, fatigue, mood, cognition and pain and 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. Our study will establish whether it is feasibe to recruit and retain patients with a diagnosis of long-COVID into a trial of CBD. We will also monitor whether there are any side effects to assess the safety and tolerability of medicinal cannabis. Our results will determine the feasibility of medicinal cannabis in the treatment of long COVID and whether it is safe to use.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Drug Science, UK
• Collaborator: Bod Healthcare Ltd
• Treatments: Cannabidiol; Epidiolex

Criteria

Inclusion Criteria:

1. Male and females aged 18-65 years old, inclusive.

2. Patient must have long COVID as defined using the COVID-19 Yorkshire Rehabilitation Scale (C19-YRS).*

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 two forms of acceptable contraception from the time of signing informed consent until 30 days after study completion.

• Sivan M, et al. (2021) The self-report version and digital format of the COVID-19 Yorkshire Rehabilitation Scale (C19-YRS) for Long Covid or Post-COVID syndrome assessment and monitoring. Adv Clin Neurosci Rehabil. https://acnr.co.uk/2021/04/digital-format-long-covid-c19-yrs-tool/

Exclusion Criteria:

1. Serious medical and/or psychiatric illnesses/disorders that will require treatment during the trial period.

2. 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.

3. Cannabis dependence or any other drug or alcohol dependence within the past two years.

4. History of drug abuse within the past 2 years (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, phencyclidine, ecstasy, methamphetamines, methadone and opiates)

5. Known hypersensitivity to cannabis-based products or any of the excipients in the study drug.

6. Use of any investigational within 30 days of screening day.

7. Use of anti-coagulant drugs such as warfarin or those known to be metabolised by CYP450 enzymes.

8. History of attempted suicide in the past 12 months.

9. History of liver impairment with current abnormal live function tests (LFTs).