Trial · NCT04997395
Feasibility of Cannabidiol for the Treatment of Long COVID
NCT04997395, Phase 2, Completed, Bod Australia
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Feasibility of Cannabidiol for the Treatment of Long COVID. Trials, record NCT04997395. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04997395
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Feasibility of Cannabidiol for the Treatment of Long COVID
- NCT number
- NCT04997395
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Bod Australia
- Conditions
- Long COVID
- Interventions
- MediCabilis Cannabis sativa 50
- First posted
- 2021-08-09
- Last updated
- 2023-01-19
- Other registries' IDs
- eudract:2021-004534-11
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recruitment rate | 12 months (48 weeks) | Recruiting individuals diagnosed with long COVID into a treatment trial of medicinal cannabis |
| Primary | Tolerability for the treatment of long COVID | 6 months (24 weeks) | 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. |
| Primary | Number of side effects | 6 months (24 weeks) | Adverse events, side effects |
| Secondary | Long COVID symptoms | 5 months (20 weeks) | Assessed by the COVID-19 Yorkshire Rehabilitation Scale (C19-YRS, Sivan et al., 2021). This scale 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. |
| Secondary | Fatigue | 5 months (20 weeks) | Fatigue 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. |
| Secondary | Self-reported quality of life | 5 months (20 weeks) | 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. |
| Secondary | Pain score | 5 months (20 weeks) | 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. |
| Secondary | Mood (anxiety) | 5 months (20 weeks) | The Generalised Anxiety Disorder Assessment (GAD-7; Spitzer et al., 2006) will be used to measure depression. The GAD-7 is a seven-item instrument that is used to measure or assess the severity of generalised anxiety disorder (GAD). Each item asks the individual to rate the severity of their symptoms over the past two weeks. Response options include "not at all", "several days", "more than half the days" and "nearly every day". The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions. GAD-7 total score for the seven items ranges from 0 to 21. |
| Secondary | Mood (depression) | 5 months (20 weeks) | 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. It is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of not at all, several days, more than half the days, and nearly every day, respectively. PHQ-9 total score for the nine items ranges from 0 to 27. |
| Secondary | Sleep quality | 5 months (20 weeks) | Assessed using Pittsburgh 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' total time in sleep and time in sleep stages (light, deep and REM sleep), as well as a daily Sleep Score accessed via the Fitbit app. Seven day averages (means) of the Fitbit measures will be calculated for each participant across the duration of the study. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04997395
GET https://conductscience.org/api/trials/v1/NCT04997395/registered