Double-Blind Randomized Placebo-Controlled Trial of a Proprietary Full Hemp Flower Formulation for Long COVID

NCT05467904 | Withdrawn

• 1 other identifier: BHC402-2022
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-acute COVID-19 Syndrome

Outcome Measures

Primary Outcomes (2)

• Patient Global Impression of Change (PGIC)

  PGIC is a 7 point scale rating individuals perception of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."

  Change in PGIC from beginning to end of treatment at 30 days

• Total Symptom Score (TSS)

  TSS is the sum of patient-reported scores (0-5 scale, 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe) for each of 10 symptoms, specifically: (i) fatigue/weakness; (ii) pain, e.g., musculoskeletal, allodynia; (iii) brain fog; (iv) dysautonomia, e.g., tachycardia, hypotension, orthostatic intolerance, dizziness, vertigo, light-headedness, syncope, gastrointestinal/urinary issues; (v) headaches, including head/neck discomfort; (vi) sensory problems, e.g., sensitivity to light, sound, odor, taste, touch, or problems such as blurry vision, tinnitus, etc; (vii) sleep difficulties; (viii) shortness of breath; (ix) flu-like symptoms, e.g., sore throat, tender lymph nodes, feverishness, sinus or nasal congestion; and (x) mood disorders, e.g., anxiety, depression.

  Change in TSS from beginning to end of treatment at 30 days

Secondary Outcomes (5)

• Insomnia Severity Index

  Univariate time series analysis of change/trend of weekly responses over 30 days

• Harvard Flourishing Index (HFI)

  Univariate time series analysis of change/trend of weekly responses over 30 days

• DANA Brain Vital

  Univariate time series analysis of change/trend of weekly cognitive efficiency over 30 days

• Hours of Upright Activity

  Univariate time series analysis of change/trend of daily responses over 30 days

• Daily Steps

  Univariate time series analysis of change/trend of daily steps over 30 days

Study Arms (3)

Xltranplus

ACTIVE COMPARATOR

Xltanplus is a full hemp flower formulation with cannabinoids and terpenes

Other: Xltranplus, Xltran

Xltran

ACTIVE COMPARATOR

Xltran contains terpenes extracted from the hemp flower

Other: Xltranplus, Xltran

Placebo

PLACEBO COMPARATOR

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

Other: Xltranplus, Xltran

Interventions

Xltranplus, Xltran OTHER

Xltranplus and Xltran are full hemp flower formulations

Placebo; Xltran; Xltranplus

Eligibility Criteria

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

You may qualify if:

• Willing and able to read, understand, and sign the informed consent
• 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.
• 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
• Male and female patients, 18-65 years of age
• a. Female patients of child-bearing potential must have a negative urine pregnancy test at Visit 1. Women confirmed to be of non-childbearing potential do not require pregnancy testing. To be considered of non-child-bearing potential, the patient must be: i. Post-menopausal (defined as no menses for at least one year); or ii. Surgically sterile (s/p hysterectomy, bilateral oophorectomy, or bilateral tubal ligation at least six months prior to beginning treatment with study product); or iii. At least three months s/p a non-surgical permanent sterilization procedure b. Females of child-bearing potential must be willing to utilize an effective birth control method for the duration of the study. Women involved in monogamous same-sex relationships or committed to sexual abstinence (e.g., religious reasons) will be waived from this requirement. Allowable contraceptive methods include: i. Oral, implantable, injectable, or transdermal hormonal contraceptives (should have been used for a minimum of one full cycle prior to administration of study product) ii. Intrauterine devices (IUD) iii. Vasectomized partner iv. Double barrier method (male or female condom, sponge, diaphragm, or vaginal ring with simultaneous use of spermicidal jelly or cream)
• A urine drug screen performed at the Visit 1 must be negative for drugs of abuse such as methamphetamine, cocaine, phencyclidine (PCP), marijuana metabolites, and non-disclosed amphetamines and opioids/opiates. The following stipulations also apply:
• a. Patients with a positive screening UDS due to prescribed amphetamines for allowed conditions do not require further UDS testing. They may proceed with study treatment, assuming no evidence of abuse or dependency.
• Patients should not require treatment with warfarin, heparin, lithium, digoxin, amiodarone, isoniazid, phenytoin, fluconazole, methotrexate, probenecid, or raloxifene. Patients on these medications should not be screened.
• Patients agree to refrain from taking medications that would affect assessment of the effectiveness of study product for the duration of the study
• Willing and able to comply with all protocol-specified requirements
• Have a smart phone and internet access to complete online surveys and cognitive testing

You may not qualify if:

• Improvement in fatigue and physical function because of any treatment intervention in the past month
• Use of Xltran Plus™ or Xltran™ within 30 days of Visit 1.
• Current use of marijuana or medical cannabis
• Currently receiving chronic/daily systemic corticosteroids (\>5 mg prednisone daily, or equivalent)
• BMI \<20 or \>40
• Breastfeeding or pregnant, or planning to become pregnant during the next six months
• In the opinion of the Investigator, any clinically significant, uncontrolled, or unstable medical or surgical condition that could affect the patient's ability to participate in the study or potentially compromise their well-being while enrolled in the study
• a. Symptomatic and/or otherwise clinically significant cardiac disease, including but not limited to: myocardial infarction during the preceding two years; uncontrolled hypertension; symptomatic heart failure (e.g., New York Heart Association Class II or higher); angina or other evidence of significant coronary artery disease; or anticipation of bypass or other cardiac surgery within the next 12 months
• In the opinion of the Investigator, evidence of a clinically significant psychiatric disorder; e.g., severe, unstable or poorly controlled depression, anxiety or obsessive-compulsive disorder; moderate or severe alcohol use disorder; substance use disorder; or any history of bipolar disorder, schizophrenia, schizoaffective disorder or other psychotic disorder
• History of suicide attempt or other suicidal behavior in the previous two years.
• Any anticipated need for surgery that might confound results or interfere with the patient's ability to comply with the protocol
• Known allergies to hemp seeds, medical cannabis, sunflower lecithin or polysorbate
• Current enrollment in any other research or clinical trial

Sponsors & Collaborators

• LUCINDA BATEMAN, MD: lead
• Endourage, LLC: collaborator

Study Sites (1)

Bateman Horne Center

Salt Lake City, Utah, 84102, United States

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

• Lucinda Bateman, MD

  Chief Medical Officer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 21, 2022
• Study Start: August 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 17, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)