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
|Condition or disease||Intervention/treatment||Phase|
|Long COVID||Drug: Full spectrum cannabidiol dominant medicinal cannabis||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Full spectrum cannabidiol dominant medicinal cannabis
Drug: Full spectrum cannabidiol dominant medicinal cannabis
Full spectrum cannabidiol dominant medicinal cannabis
Other Name: MediCabilis
- Recruitment rate [ Time Frame: 12 months ]Recruiting individuals diagnosed with long-COVID into a treatment trial of medicinal cannabis
- 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.
- Number of side effects [ Time Frame: 6 months ]Adverse events, side effects
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Michael Lynskey, PhD||+44 email@example.com|
|Contact: Hannah Thurgur, PhDfirstname.lastname@example.org|
|Study Director:||Michael Lynskey, PHD||Drug Science|