Clinical trial NCT06163690: Symptom Tracking in Long COVID Patients Using Formula C™ Sublingual Drops
Official title: Digital Symptom Tracking and Wellness in Long COVID Patients Using Endourage Targeted Wellness Formula C™ Sublingual Drops
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Long COVID
Long Covid19
Post-Acute COVID-19
Post-Acute COVID-19 Syndrome
Long Haul COVID
Long-Haul COVID-19
Keywords: Hemp
Terpenes
Cannabinoids
Entourage effect
Lead sponsor: Endourage, LLC
Sponsor class: INDUSTRY
First posted: 2023-12-11
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People located in the U.S. that have been diagnosed with Long COVID and are being treated by a physician for Long COVID symptoms.

Brief summary: This is a digital symptom tracking study of Formula C™, a full cannabis flower formulation, rich in cannabinoids and terpenes, that has been shown to improve symptoms in people with Long COVID. Participants 21 and older will take Formula C™ for 90 days. During that time, participants will answer weekly surveys to track symptoms and wellbeing.

Detailed description: Long COVID is a global health crisis with no current treatments. There's a growing interest within the medical community to explore the potential benefits of full hemp flower extracts in treating and alleviating Long COVID symptoms. Full hemp flower extracts are a remarkable advancement in the field of natural wellness and healing. Full hemp flower extracts harness the full spectrum of beneficial compounds present in the hemp plant, including not just cannabidiol (CBD), but a host of other cannabinoids, terpenes, and flavonoids. This process, known as 'whole plant' or 'full spectrum' extraction, produces a more potent and therapeutic product, as the various compounds work synergistically in what is referred to as the 'entourage effect'. These extracts have been associated with a broad range of potential health benefits, such as pain relief, reduction of inflammation, anxiety management, and sleep improvement. A recently published single-blind, randomized, placebo controlled trial demonstrated that Long COVID patients benefitted from sublingual use of Formula C without any safety events. This remote, observational study of Endourage Targeted Wellness Formula C™ sublingual drops will seek to empower participants to track symptoms and wellbeing while taking Formula C to determine if Long COVID symptoms are attenuated and time to healing is shortened.

Eligibility criteria: Inclusion Criteria:

1. Must be at least 21 years of age.
2. Willing and able to read, understand, and sign the informed consent.
3. Willing to comply with all study procedures.
4. Must have device to access the internet to complete surveys online.
5. A diagnosis of Long COVID from a health care provider.

Exclusion Criteria:

1. Non-English speaking, as the surveys are developed in the English language.
2. Known allergies to hemp seeds or hemp-derived products, medical cannabis, coconut oil.
3. Pregnancy, or planning to become pregnant in the next 3 months

Primary outcomes:
measure: Symptom and wellbeing change over 3 months
timeFrame: 90 days
Secondary outcomes:
measure: Patient Global Impression of Change
timeFrame: 90 days
Other outcomes:
Locations:
city: Denver
country: United States
facility: Endourage, LLC
state: Colorado
Study officials:
affiliation: Endourage, LLC
name: Michael Steward, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Young TP, Erickson JS, Hattan SL, Guzy S, Hershkowitz F, Steward MD. A Single-Blind, Randomized, Placebo Controlled Study to Evaluate the Benefits and Safety of Endourage Targeted Wellness Formula C Sublingual +Drops in People with Post-Acute Coronavirus Disease 2019 Syndrome. Cannabis Cannabinoid Res. 2024 Feb;9(1):282-292. doi: 10.1089/can.2022.0135. Epub 2022 Oct 14.