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

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.