Post-acute COVID-19 SyndromeNCT05467904
Double-Blind Randomized Placebo-Controlled Trial of a Proprietary Full Hemp Flower Formulation for Long COVID
A study testing Xltranplus, Xltran in people with Post-acute COVID-19 Syndrome, run by LUCINDA BATEMAN, MD at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-acute COVID-19 Syndrome
- What is being tested?
- Xltranplus, Xltran
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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
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- 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:
- 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
Who cannot join
- 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
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- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind Randomized, Placebo-Controlled Trial of a Proprietary Full Hemp Flower Formulation ( Xltran™ and Xltranplus™) to Determine Clinical Improvement in the Syndrome of Long COVID
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.
Read the detailed description
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 the treatment of Long COVID in adults. The treatment consists of daily doses of Xltran Plus™, Xltran™, or placebo. Xltran Plus™ contains 10.42 mg of cannabinoids, 0.55 mg tetrahydrocannabinol (THC), and 2.729 mg of terpenes per 0.25 ml of solution. Xltran™ contains 0 mg of cannabinoids, 0 mg THC and 1.28 mg terpene per 0.25 ml of solution. Placebo contains water, sunflower lecithin and polysorbate. Trial participants will be randomized to Xltran Plus™, Xltran™ or placebo at Visit 1. Participants will take 1 ml sublingually after morning meal and 1 ml sublingually after the evening meal for 28 days.
There will be 111 patients with Long COVID enrolled. There will be approximately 37 patients randomized to each arm.
Candidates will undergo initial pre-screening by telephone, after which, if they appear to meet initial entry criteria, will be invited for an in-person visit. The first visit, Visit 1, will include vitals, symptom questionnaires, cognitive testing, and urine and blood sampling. Participants will receive weekly symptom surveys to complete online. Each participant will be instructed on cognitive testing using their smart phone and complete the cognitive testing weekly.
Patients with underlying medical or psychiatric conditions that could impact their safe participation in the study or interfere with their ability to complete or comply with the study's requirements will not be enrolled. Patients on active illicit or non-prescribed drug use and chronic, daily use of an immune suppressant (e.g., prednisone) will be excluded. Patients with documented history and active treatment for seizure disorder, and any condition that in the opinion of the investigator would be harmful or detrimental to the patient will not be enrolled in the study.
Patients may remain on stable doses of opioids, SSRIs and other anti-depressants; however, poorly controlled, or severely depressed patients will not be enrolled. Only clinically stable and well-controlled patients will be considered.
At Visit 1, the PI will ensure that all entry criteria have been satisfied and the participant will be randomized and initiate treatment with one dose on the day of the Visit 1 (Day 1), followed by BID dosing for the duration of the study.
Urine will be collected at Visit 1 for pregnancy testing. Urine drug screening for drugs of abuse will be conducted at Visit 1; patients positive for cocaine, methamphetamine, phencyclidine (PCP), methadone, non-disclosed opiates, or marijuana metabolites should be screen failed. Patients positive for disclosed, stable doses of prescribed opioids are able and may remain on these medications during the study. Additional drug testing may be conducted at the investigator's discretion.
A blood sample will be collected at Day 1 (Visit 1) and Day 28 (Visit 2) for changes in inflammatory markers.
Patients will receive assigned study treatment for a total of 28 days, with treatment dispensed at Visit 1 (Day 1) and the amount of treatment remaining, if any, accounted for at Visit 2 (Day 28) end of treatment visit.
At the end of the trial and after results are unblinded, those who received placebo will be provided with a 28-day supply each of Xltran Plus™ and Xltran™ if they are interested.
- Conditions
- Post-acute COVID-19 Syndrome
- Being tested
- Xltranplus, Xltran
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xltranplus, XltranOther
Xltranplus and Xltran are full hemp flower formulations
| Study group | Role | What they receive |
|---|---|---|
| Xltranplus | Active comparator | Xltanplus is a full hemp flower formulation with cannabinoids and terpenes Receives: Other: Xltranplus, Xltran |
| Xltran | Active comparator | Xltran contains terpenes extracted from the hemp flower Receives: Other: Xltranplus, Xltran |
| Placebo | Placebo comparator | Placebo will be an inactive formulation of water, sunflower lecithin and polysorbate Receives: Other: Xltranplus, Xltran |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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.
Measured: Change in TSS from beginning to end of treatment at 30 days
Secondary outcomes (5)
Insomnia Severity Index
A brief 7 item instrument to assess the severity of both nighttime and daytime components of insomnia
Measured: Univariate time series analysis of change/trend of weekly responses over 30 days
Harvard Flourishing Index (HFI)
Consists of two questions or items from each of the five main subscales: happiness and life satisfaction, mental and physical health, meaning and purpose, character and virtue, and close social relationships.
Measured: Univariate time series analysis of change/trend of weekly responses over 30 days
DANA Brain Vital
Assessment of reaction time cognitive efficiency
Measured: Univariate time series analysis of change/trend of weekly cognitive efficiency over 30 days
Hours of Upright Activity
Self-reported time with feet on the floor over a 24 hours period
Measured: Univariate time series analysis of change/trend of daily responses over 30 days
Daily Steps
Daily steps over a 24 hour period
Measured: Univariate time series analysis of change/trend of daily steps over 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study startAug 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-acute COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- LUCINDA BATEMAN, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Endourage, LLC
- Responsible party
- Sponsor-investigator, LUCINDA BATEMAN, MD, Bateman Horne Center
- Investigators
- Lucinda Bateman, MD, Principal investigator, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467904
- Sponsor's protocol ID
- BHC402-2022
- Status last verified
- Mar 2024
- First submitted
- 18 Jul 2022
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Randomized, Placebo-Controlled Trial of a Proprietary Full Hemp Flower Formulation ( Xltran™ and Xltranplus™) to Determine Clinical Improvement in the Syndrome of Long COVID
- ClinicalTrials.gov ID
- NCT05467904
- Acronym / sponsor ID
- BHC402-2022
- Conditions
- Post-acute COVID-19 Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- LUCINDA BATEMAN, MDUniversity, hospital or other
- Collaborators
- Endourage, LLC
- Study start
- Aug 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 the treatment of Long COVID in adults. The treatment consists of daily doses of Xltran Plus™, Xltran™, or placebo. Xltran Plus™ contains 10.42 mg of cannabinoids, 0.55 mg tetrahydrocannabinol (THC), and 2.729 mg of terpenes per 0.25 ml of solution. Xltran™ contains 0 mg of cannabinoids, 0 mg THC and 1.28 mg terpene per 0.25 ml of solution. Placebo contains water, sunflower lecithin and polysorbate. Trial participants will be randomized to Xltran Plus™, Xltran™ or placebo at Visit 1. Participants will take 1 ml sublingually after morning meal and 1 ml sublingually after the evening meal for 28 days.
There will be 111 patients with Long COVID enrolled. There will be approximately 37 patients randomized to each arm.
Candidates will undergo initial pre-screening by telephone, after which, if they appear to meet initial entry criteria, will be invited for an in-person visit. The first visit, Visit 1, will include vitals, symptom questionnaires, cognitive testing, and urine and blood sampling. Participants will receive weekly symptom surveys to complete online. Each participant will be instructed on cognitive testing using their smart phone and complete the cognitive testing weekly.
Patients with underlying medical or psychiatric conditions that could impact their safe participation in the study or interfere with their ability to complete or comply with the study's requirements will not be enrolled. Patients on active illicit or non-prescribed drug use and chronic, daily use of an immune suppressant (e.g., prednisone) will be excluded. Patients with documented history and active treatment for seizure disorder, and any condition that in the opinion of the investigator would be harmful or detrimental to the patient will not be enrolled in the study.
Patients may remain on stable doses of opioids, SSRIs and other anti-depressants; however, poorly controlled, or severely depressed patients will not be enrolled. Only clinically stable and well-controlled patients will be considered.
At Visit 1, the PI will ensure that all entry criteria have been satisfied and the participant will be randomized and initiate treatment with one dose on the day of the Visit 1 (Day 1), followed by BID dosing for the duration of the study.
Urine will be collected at Visit 1 for pregnancy testing. Urine drug screening for drugs of abuse will be conducted at Visit 1; patients positive for cocaine, methamphetamine, phencyclidine (PCP), methadone, non-disclosed opiates, or marijuana metabolites should be screen failed. Patients positive for disclosed, stable doses of prescribed opioids are able and may remain on these medications during the study. Additional drug testing may be conducted at the investigator's discretion.
A blood sample will be collected at Day 1 (Visit 1) and Day 28 (Visit 2) for changes in inflammatory markers.
Patients will receive assigned study treatment for a total of 28 days, with treatment dispensed at Visit 1 (Day 1) and the amount of treatment remaining, if any, accounted for at Visit 2 (Day 28) end of treatment visit.
At the end of the trial and after results are unblinded, those who received placebo will be provided with a 28-day supply each of Xltran Plus™ and Xltran™ if they are interested.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Xltranplus | Active comparator | Other: Xltranplus, XltranXltanplus is a full hemp flower formulation with cannabinoids and terpenes |
| Xltran | Active comparator | Other: Xltranplus, XltranXltran contains terpenes extracted from the hemp flower |
| Placebo | Placebo comparator | Other: Xltranplus, XltranPlacebo will be an inactive formulation of water, sunflower lecithin and polysorbate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Willing and able to read, understand, and sign the informed consent
- Diagnosis of Long COVID is defined as the following:
- Male and female patients, 18-65 years of age
- 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:
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xltranplus, XltranXltranplus and Xltran are full hemp flower formulations | Other | Placebo, Xltran, Xltranplus |
Primary outcome
Patient Global Impression of Change (PGIC)
Time frame: Change in PGIC from beginning to end of treatment at 30 days
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."
Total Symptom Score (TSS)
Time frame: Change in TSS from beginning to end of treatment at 30 days
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.
5 secondary outcomes
Insomnia Severity Index
Time frame: Univariate time series analysis of change/trend of weekly responses over 30 days
Harvard Flourishing Index (HFI)
Time frame: Univariate time series analysis of change/trend of weekly responses over 30 days
DANA Brain Vital
Time frame: Univariate time series analysis of change/trend of weekly cognitive efficiency over 30 days
Hours of Upright Activity
Time frame: Univariate time series analysis of change/trend of daily responses over 30 days
Daily Steps
Time frame: Univariate time series analysis of change/trend of daily steps over 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucinda Bateman, MD principal investigator
Chief Medical Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xltranplus, Xltran in people with Post-acute COVID-19 Syndrome, run by LUCINDA BATEMAN, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Global Impression of Change (PGIC) (time frame: Change in PGIC from beginning to end of treatment at 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.