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

Prior treatment

• Currently receiving chronic/daily systemic corticosteroids (>5 mg prednisone daily, or equivalent)
• 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

Other illness

• 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
• Known allergies to hemp seeds, medical cannabis, sunflower lecithin or polysorbate

Other

• 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
• BMI <20 or >40
• Breastfeeding or pregnant, or planning to become pregnant during the next six months
• Current enrollment in any other research or clinical trial

• 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
  • 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