Cannabis Formulations for Post-COVID Syndrome

Overseen By Suzanne D Vernon, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: LUCINDA BATEMAN, MD

Must not be taking: Warfarin, Heparin, Lithium, others

Disqualifiers: Cardiac disease, Psychiatric disorder, others

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two cannabis-based treatments, Xltran Plus and Xltran, for individuals dealing with Long COVID. Researchers aim to determine if these treatments can reduce symptoms such as ongoing fatigue, muscle weakness, and cognitive issues that persist after a COVID-19 infection. Participants will receive either one of the cannabis formulations or a placebo (inactive substance) to compare effects. Suitable candidates have had a confirmed COVID-19 infection in the last 36 months and continue to experience persistent fatigue and muscle weakness. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on potential new treatments for Long COVID.

Will I have to stop taking my current medications?

The trial requires that you do not take certain medications like warfarin, heparin, lithium, and others listed in the criteria. You also need to avoid medications that could affect the study's results. If you're on any of these, you might need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cannabis-based medicines, such as Xltran Plus and Xltran, may alleviate symptoms, including those from Long COVID. In earlier studies, products like Xltran Plus, which contain cannabinoids and terpenes, were tested for safety and effectiveness. These studies did not find any serious side effects directly caused by the treatment.

For Xltran, another cannabis-based product, some participants left the studies, but not due to negative effects from the treatment. This suggests that both Xltran Plus and Xltran are generally well-tolerated by participants.

It's important to remember that these treatments are still under investigation. However, early results suggest they could be safe options for managing Long COVID symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for post-COVID syndrome, which often focus on symptom management with pain relievers or anti-inflammatory drugs, Xltran and Xltranplus offer a novel approach. Xltranplus is unique because it includes a full hemp flower formulation with cannabinoids and terpenes, which may offer a more holistic therapeutic effect. Xltran, on the other hand, contains terpenes extracted specifically from the hemp flower, aiming to harness the potential benefits of these compounds. Researchers are excited about these treatments because they utilize natural compounds that may target the condition's underlying mechanisms in a new way, potentially offering relief where conventional treatments fall short.

What evidence suggests that this trial's treatments could be effective for Long COVID?

Research has shown that certain components of cannabis, like CBD, might help reduce inflammation and improve symptoms for people with Post-COVID Syndrome. In this trial, participants will receive either Xltranplus™ or Xltran™. Early results suggest that cannabis products rich in cannabinoids and terpenes, such as Xltranplus™, have potential in easing symptoms of similar conditions. Studies indicate that these compounds can help manage inflammation and may have antioxidant effects, which could benefit Long COVID patients. Xltran™, which includes terpenes from hemp, also utilizes these potential benefits. While more research is needed, these products are under study for their potential to relieve ongoing COVID-19 symptoms. ^{1 3 4 6 7}

Who Is on the Research Team?

Lucinda Bateman, MD

Principal Investigator

Chief Medical Officer

Are You a Good Fit for This Trial?

Adults aged 18-65 with Long COVID, confirmed by a positive SARS-CoV-2 test within the last 36 months and experiencing persistent fatigue, muscle weakness, functional and cognitive impairments. Participants must not take other medications that could affect the trial's outcome, have no recent improvements due to treatments, not be pregnant or breastfeeding, and agree to use effective birth control if applicable.

Inclusion Criteria

Diagnosis of Long COVID is defined as the following: Infected individuals will have a confirmed SARS-CoV-2 infection within 36 months of enrollment and have had at least one month of persistent fatigue and muscle weakness, functional impairment, and cognitive impairment since the acute infection.

Patients agree to refrain from taking medications that would affect assessment of the effectiveness of study product for the duration of the study

Adults with confirmed prior SARS-CoV-2 infection will satisfy any one of the following: i. Any person with a positive SARS-CoV-2 polymerase chain reaction (PCR) or nucleic acid amplification test (NAAT); ii. Any person with a positive SARS-CoV-2 antigen rapid diagnostic test; iii. Any person with a positive SARS-CoV-2 antibody test

Exclusion Criteria

You have experienced improved energy levels and physical abilities due to any treatment within the last month.

Use of Xltran Plus™ or Xltran™ within 30 days of Visit 1.

Currently receiving chronic/daily systemic corticosteroids (>5 mg prednisone daily, or equivalent)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person), pre-screening by telephone

Treatment

Participants receive daily doses of Xltran Plus™, Xltran™, or placebo for Long COVID treatment

4 weeks

2 visits (in-person), weekly online symptom surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants who received placebo may opt to receive a 28-day supply of Xltran Plus™ and Xltran™

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Xltran
• Xltranplus

Trial Overview The trial is testing Xltran Plus™ and Xltran™ against a placebo in people with Long COVID. It aims to determine how safe these full cannabis flower formulations are and how well they work in reducing prolonged symptoms caused by COVID-19.

How Is the Trial Designed?

Group I: Xltranplus Active Control 1 Intervention

Xltanplus is a full hemp flower formulation with cannabinoids and terpenes

Group II: Xltran Active Control 1 Intervention

Xltran contains terpenes extracted from the hemp flower

Group III: Placebo Placebo Group 1 Intervention

Placebo will be an inactive formulation of water, sunflower lecithin and polysorbate

Who Is Running the Clinical Trial?

LUCINDA BATEMAN, MD

Lead Sponsor

Trials

2

Recruited

130+

Endourage, LLC

Industry Sponsor

Trials

4

Recruited

160+

Published Research Related to This Trial

A new liquid chromatographic-tandem mass spectrometric (LC-MS/MS) method was successfully developed to accurately identify and quantify THC and CBD in olive oil, showing linearity and low imprecision over a range of concentrations.

The extraction efficiency of THC and CBD from olive oil can be significantly improved by optimizing the extraction temperature, with a 2°C increase leading to a notable rise in extraction percentages for both cannabinoids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Use of Δ9-THC and Cannabidiol: Evaluation of a New Extraction Procedure for the Preparation of Cannabis-based Olive Oil. Morini, L., Porro, G., Liso, M., et al.[2018]

PTL101, an oral formulation of highly purified CBD, was found to be safe and well-tolerated in healthy volunteers, showing a significant increase in CBD absorption compared to the Sativex oromucosal spray.

The 10 mg dose of PTL101 demonstrated 134% bioavailability relative to the reference spray, indicating that it delivers CBD more effectively, which could make it a promising option for therapeutic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-Dose Pharmacokinetics of Oral Cannabidiol Following Administration of PTL101: A New Formulation Based on Gelatin Matrix Pellets Technology. Atsmon, J., Heffetz, D., Deutsch, L., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-syndrome-9-2022-df889?lat=34.60184&lng=-117.81218

Cannabis Formulations for Post-COVID Syndrome Research suggests that components found in cannabis, like CBD, may help reduce inflammation and improve symptoms in people with Post-COVID Syndrome by targeting ...

2. explorationpub.com explorationpub.com/uploads/Article/A1001158/1001158.pdf

Cannabis-based medicinal products (CBMPs) for the ... The World Health Organization (WHO) defines post COVID-19 as symptoms that occur 3 months from the onset of an acute COVID-19 infection and that ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11012123/

Possible Role of Cannabis in the Management of ... It has been shown that cannabis has compounds with immunomodulatory and antioxidant functions in other pathologies.

4. researchgate.net researchgate.net/publication/373570965_Cannabis-based_medicinal_products_CBMPs_for_the_treatment_of_Long_COVID_symptoms_current_and_potential_applications

(PDF) Cannabis-based medicinal products (CBMPs) for the ... This review summarises current clinical trials and studies exploring CBMPs in Long COVID. The current evidence provides a rationale to further ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05467904

Study Details | NCT05467904 | Double-Blind Randomized ... This is a double-blind, randomized, placebo-controlled single-center, 28-day study designed to explore the safety and efficacy of Xltran Plus™ and Xltran™ for ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36252151/

A Single-Blind, Randomized, Placebo Controlled Study to ... Results: Twenty-four participants completed study, with 8 withdrawals, none related to study product. PGIC and PROMIS scores improved across ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06163690

Symptom Tracking in Long COVID Patients Using Formula ... This is a digital symptom tracking study of Formula C™, a full cannabis flower formulation, rich in cannabinoids and terpenes, that has been shown to improve ...