Feasibility of Cannabidiol for the Treatment of Long COVID

NCT04997395 | Completed Phase 2 DMC

• 2 other identifiers: BOD202102U2021-004534-11
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Long COVID

Keywords

long COVID; COVID; cannabidiol; post-COVID-19 syndrome; post-COVID syndrome

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  Recruiting individuals diagnosed with long COVID into a treatment trial of medicinal cannabis

  12 months (48 weeks)

• Tolerability for the treatment of long COVID

  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.

  6 months (24 weeks)

• Number of side effects

  Adverse events, side effects

  6 months (24 weeks)

Secondary Outcomes (11)

• Long COVID symptoms

  5 months (20 weeks)

• Fatigue

  5 months (20 weeks)

• Self-reported quality of life

  5 months (20 weeks)

• Pain score

  5 months (20 weeks)

• Mood (anxiety)

  5 months (20 weeks)

Study Arms (1)

MediCabilis Cannabis sativa 50

EXPERIMENTAL

The medicinal cannabis used for this study is MediCabilis Cannabis sativa 50, a full spectrum CBD dominant plant based medicinal cannabis containing 50 mg/ml CBD and 2 mg/ml THC. On commencing the oral medication, it will be titrated over a 2 week period to a dose of 1 ml twice a day (total dose 2 ml = 100 mg CBD and 4 mg THC). Participants will be given a written titration schedule at the initial clinic visit. There will be the potential for a further dose increase to a total dose of 3 ml per day (150 mg CBD and 6 mg THC) at the 1-month follow-up visit.

Drug: MediCabilis Cannabis sativa 50

Interventions

MediCabilis Cannabis sativa 50 DRUG

Already described

Also known as: MediCabilis 5%

MediCabilis Cannabis sativa 50

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and females aged 18 years old or above.
• 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
• Females must be non-pregnant, non-lactating.
• Proficient in English and have internet access and a mobile phone.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Provision of signed and dated informed consent form.
• 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.

You may not qualify if:

• Self-diagnosed Long COVID without relevant assessment and investigation as per clinical guidelines.
• 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)
• 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.
• Cannabis dependence or any other drug or alcohol dependence within the past two years.
• Known hypersensitivity to cannabis-based products or any of the excipients in the study drug.
• Use of any other investigational products within 30 days of screening day.
• Use of anti-coagulant drugs such as warfarin.
• History of attempted suicide, bipolar disorder or schizophrenia.
• 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.
• History of allergy to tree nuts, with no definite previous coconut exposure.

Sponsors & Collaborators

• Bod Australia: lead
• Drug Science, UK: collaborator

Study Sites (1)

Drug Science

York, United Kingdom

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elizabeth Iveson

  Steps Neurorehabilitation Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2021
• First Posted: August 9, 2021
• Study Start: April 14, 2022
• Primary Completion: January 6, 2023
• Study Completion: January 6, 2023
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

GB (1)