111 Participants Needed

Cannabis Formulations for Post-COVID Syndrome

SD
Overseen BySuzanne D Vernon, PhD

Trial Summary

What is the purpose of this trial?

This is a double-blind, randomized, placebo-controlled single-center clinical trial to explore the safety and efficacy of a full cannabis flower formulation, rich in cannabinoids and terpenes formulation, Xltran Plus™ and Xltran™, both compared to placebo for the treatment of Long COVID patients with prolonged symptoms caused by COVID-19.

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.

What data supports the effectiveness of the treatment Xltran and Xltranplus 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 proteins involved in the condition. Additionally, studies have shown that cannabis extracts can downregulate inflammatory pathways, which might be beneficial for managing post-COVID symptoms.12345

Is cannabis generally safe for humans?

The available research suggests that cannabis use during the COVID-19 pandemic has been associated with increased hospitalizations and adverse psychiatric outcomes, indicating potential safety concerns. However, the studies are mostly based on self-reports and have limitations, so more research is needed to fully understand the safety of cannabis use.678910

How does the drug Xltran/Xltranplus differ from other treatments for post-COVID syndrome?

Xltran and Xltranplus are unique because they are cannabis-based formulations potentially utilizing cannabinoids like THC and CBD, which may offer anti-inflammatory and neuroprotective effects. Unlike standard treatments, these formulations might be delivered through innovative methods like oromucosal sprays or oral gelatin matrix pellets, enhancing bioavailability and providing precise dosing.1112131415

Research Team

LB

Lucinda Bateman, MD

Principal Investigator

Chief Medical Officer

Eligibility Criteria

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
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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)
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Timeline

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

Treatment Details

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.
Participant Groups
3Treatment groups
Active Control
Placebo Group
Group I: XltranplusActive Control1 Intervention
Xltanplus is a full hemp flower formulation with cannabinoids and terpenes
Group II: XltranActive Control1 Intervention
Xltran contains terpenes extracted from the hemp flower
Group III: PlaceboPlacebo Group1 Intervention
Placebo will be an inactive formulation of water, sunflower lecithin and polysorbate

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Who Is Running the Clinical Trial?

LUCINDA BATEMAN, MD

Lead Sponsor

Trials
2
Recruited
130+

Endourage, LLC

Industry Sponsor

Trials
4
Recruited
160+

Findings from Research

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.
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]
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.
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]

References

A Single-Blind, Randomized, Placebo Controlled Study to Evaluate the Benefits and Safety of Endourage Targeted Wellness Formula C Sublingual +Drops in People with Post-Acute Coronavirus Disease 2019 Syndrome. [2022]
Cannabis Use Is Associated With Lower COVID-19 Susceptibility but Poorer Survival. [2023]
In silico inquest reveals the efficacy of Cannabis in the treatment of post-Covid-19 related neurodegeneration. [2022]
Fighting the storm: could novel anti-TNFα and anti-IL-6 C. sativa cultivars tame cytokine storm in COVID-19? [2023]
New AKT-dependent mechanisms of anti-COVID-19 action of high-CBD Cannabis sativa extracts. [2022]
Cannabis use, abuse and dependence during the COVID-19 pandemic: a scoping review. [2023]
Changes in medical and non-medical cannabis use among United States adults before and during the COVID-19 pandemic. [2022]
The association between preconception cannabis use and depression and anxiety during pregnancy. [2023]
A Scoping Review on the Medical and Recreational Use of Cannabis During the COVID-19 Pandemic. [2023]
Pregnant individual's lived experience of cannabis use during the COVID-19 pandemic: a qualitative study. [2023]
A Phase I Trial to Determine the Pharmacokinetics, Psychotropic Effects, and Safety Profile of a Novel Nanoparticle-Based Cannabinoid Spray for Oromucosal Delivery. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
The safety, tolerability, and effectiveness of PTL-101, an oral cannabidiol formulation, in pediatric intractable epilepsy: A phase II, open-label, single-center study. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
Long-term effectiveness and safety of medical cannabis administered through the metered-dose Syqe Inhaler. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
Single-Dose Pharmacokinetics of Oral Cannabidiol Following Administration of PTL101: A New Formulation Based on Gelatin Matrix Pellets Technology. [2022]
Therapeutic Use of Δ9-THC and Cannabidiol: Evaluation of a New Extraction Procedure for the Preparation of Cannabis-based Olive Oil. [2018]