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Feasibility of Cannabidiol for the Treatment of Long COVID

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ClinicalTrials.gov Identifier: NCT04997395
Recruitment Status : Not yet recruiting
First Posted : August 9, 2021
Last Update Posted : August 9, 2021
Sponsor:
Collaborator:
Bod Healthcare Ltd
Information provided by (Responsible Party):
Elizabeth Iveson, Drug Science, UK

Brief 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.

Condition or disease Intervention/treatment Phase
Long COVID Drug: Full spectrum cannabidiol dominant medicinal cannabis Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Tolerability of Full Spectrum Cannabidiol Dominant Medicinal Cannabis in Treating Symptoms Associated With Long COVID: A Feasibility Study
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
Drug Information available for: Cannabidiol

Arm Intervention/treatment
Experimental: CBD
Full spectrum cannabidiol dominant medicinal cannabis
Drug: Full spectrum cannabidiol dominant medicinal cannabis
Full spectrum cannabidiol dominant medicinal cannabis
Other Name: MediCabilis




Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: 12 months ]
    Recruiting individuals diagnosed with long-COVID into a treatment trial of medicinal cannabis

  2. Tolerability for the treatment of long COVID [ Time Frame: 6 months ]
    Retaining participants in a six month trial of medicinal cannabis using the proposed battery of assessments. Retention rate (%) of participants enrolled into the trial who complete the six-month protocol.

  3. Number of side effects [ Time Frame: 6 months ]
    Adverse events, side effects


Secondary Outcome Measures :
  1. Long COVID symptoms [ Time Frame: 6 months ]
    Assessed by the C19-YRS (COVID-19 Yorkshire Rehabilitation Scale). This includes: breathlessness, cough/ voice, swallowing/ nutrition, fatigue, continence, cognition, pain/discomfort, anxiety, depression, post-traumatic stress disorder, communication, mobility, personal care, activities of daily living, social role, perceived health status and family/carers views. The C19-YRS provides an overview of 3 outcomes: symptoms severity score, functional disability score and global health score.

  2. Fatigue [ Time Frame: 6 months ]
    Fatigue, which has been identified as one of the core symptoms of long-COVID will be assessed using the nine item Fatigue Severity Scale (Krupp et al., 1989). This scale, which was initially designed for use in multiple sclerosis and systemic lupus erythematosus has been used extensively across multiple disorders and has bene demonstrated to have good reliability and validity. Each of the nine items in this scale is assessed on a seven-point scale from 1 (strongly disagree) to 7 (strongly agree). Thus, the composite scale ranges from 9 to 63 with higher ratings representing more severe fatigue.

  3. Self-reported quality of life [ Time Frame: 6 months ]
    The health-related quality of life instrument that will be used in this study is the EuroQol 5 Dimensions (EQ-5D; Devlin et al., 2017). It is a widely used, validated, and reliable tool that assesses the quality of life of patients in many disease areas through assessment of the severity of each of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 levels (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems. The digits for the five dimensions can be numerically summed into a single number, varying from 5 to 25 with higher numbers representing a lower quality of life. In addition, this measure contains a 100-point visual analogue which asks respondents to rate their current health with higher numbers representing better health.

  4. Pain score [ Time Frame: 6 months ]
    The Brief Pain Inventory Short Form (BPI-SF; Cleeland, 1989; Cleeland & Ryan, 1994), a 9 item self-administered questionnaire, will be used to evaluate the severity of a patient's pain and the interference of this pain on the patient's daily feeling and functioning. The patient rates their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10-point scale. The BPI scale defines pain as follows: 1-4=Mild Pain, 5-6=Moderate Pain, 7-10=Severe Pain. Thus, a mean of the items can be presented with higher ratings representing more severe pain. In addition, the mean of the 7 items assessing interference, each rated on a scale from 0 to 10, will be used as a measure of mean pain interference with higher numbers representing more interference.

  5. Mood/anxiety [ Time Frame: 6 months ]
    The Patient Health Questionnaire (PHQ-9; Kroneke et al., 2001) will be used to measure mood/ depression. It is a reliable and valid measure of depression severity and is comprised of a 9-item self-rated instrument that has been validated in general populations, medical populations and psychiatric samples.

  6. Sleep quality [ Time Frame: 6 months ]
    Assessed using Pittsburg self-report questionnaires and wearable technology. The Pittsburgh Sleep Quality Index (PSQI) includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality. Mean ratings on this global score will be used in our analyses. Furthermore, the wearable technology (i.e. Fitbit) will provide the patients' time in light, deep and REM sleep, as well as a daily Sleep Score in the Fitbit app.

  7. Resting heart rate (expressed as average beats per minute) [ Time Frame: 6 months ]
    The wearable technology will provide 24/7 heart rate tracking and heart rate variability. We will analyse mean resting heart rate (beats per minute) for each of the seven-day periods preceding assessments. Variation in the time between each heartbeat (heart rate variability) will also be assessed using the FitBit.

  8. Activity levels (number of daily steps, distance walked, stairs climbed, active minutes and calories burned) [ Time Frame: 6 months ]
    Activity levels assessed via wearable technology. The wearable technology (i.e. Fitbit) tracks all-day activity including number of steps walked, distance walked (expressed in kilometres), floors climbed, active minutes and calories burned. We will analyse the seven-day mean number of daily steps, distance walked, stairs climbed, active minutes and calories burned for each 7-day assessment period.

  9. Oxygen saturation (expressed as percentage saturation) [ Time Frame: 6 months ]
    Oxygen saturation expressed as percentage saturation, with typical numbers being in the region of 95% will also be assessed via the FitBit. The seven-day average oxygen saturation will be calculated for each of the assessment periods.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04997395


Contacts
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Contact: Michael Lynskey, PhD +44 7769311032 michael.lynskey@drugscience.org.uk
Contact: Hannah Thurgur, PhD 07462021080 hannah.thurgur@drugscience.org.uk

Sponsors and Collaborators
Drug Science, UK
Bod Healthcare Ltd
Investigators
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Study Director: Michael Lynskey, PHD Drug Science
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Responsible Party: Elizabeth Iveson, Principal Investigator, Drug Science, UK
ClinicalTrials.gov Identifier: NCT04997395    
Other Study ID Numbers: BOD202102U
First Posted: August 9, 2021    Key Record Dates
Last Update Posted: August 9, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: From 12 months after completion of data collection.
Access Criteria: Ethical approval obtained from recognised ethics committee/ IRB Subject to oversight and approval by research team. All identifiers to be removed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Elizabeth Iveson, Drug Science, UK:
long COVID
COVID
cannabidiol
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Cannabidiol
Anticonvulsants