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.
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.
Drug: MediCabilis Cannabis sativa 50
Already described
Other Name: MediCabilis 5%
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.
Drug Science
York, United Kingdom
Elizabeth Iveson, Principal Investigator
Steps Neurorehabilitation Unit