Long COVID, Long Covid19, Long Haul COVID, Long-Haul COVID-19, Post-Acute COVID-19, Post-Acute COVID-19 Syndrome
Conditions
Keywords
Hemp, Terpenes, Cannabinoids, Entourage effect
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.
Interventions
COMBINATION_PRODUCTEndourage Targeted Wellness Formula C™, a full hemp flower extract
A hemp-derived formulation designed as a daily use adjunctive therapy to help improve Long COVID symptoms. Endourage Targeted Wellness Formula C™ are used as sublingual drops held under the tongue for 60 to 90 seconds.
Sponsors
Endourage, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom and wellbeing change over 3 months | 90 days | This study will use the PROMIS-29+2 Profile v2.1 (PROPr) is used to calculate a change in Long COVID related symptoms including fatigue, sleep, pain, mood and physical function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Change | 90 days | The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. |
Countries
United States
Outcome results
None listed