Cannabis Formulations for Post-COVID Syndrome

Recruiting in Palo Alto (17 mi)

Overseen byLucinda Bateman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: LUCINDA BATEMAN, MD

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.

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

+7 more

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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Participant Groups

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.

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