Cannabis Formulations for Post-COVID Syndrome
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily doses of Xltran Plus™, Xltran™, or placebo for Long COVID treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants who received placebo may opt to receive a 28-day supply of Xltran Plus™ and Xltran™
Treatment Details
Interventions
- Xltran
- Xltranplus
Find a Clinic Near You
Who Is Running the Clinical Trial?
LUCINDA BATEMAN, MD
Lead Sponsor
Endourage, LLC
Industry Sponsor