Symptom Tracking in Long COVID Patients Using Formula C™ Sublingual Drops

Endourage, LLC20 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Long COVID Long Covid19 Post-Acute COVID-19 Post-Acute COVID-19 Syndrome Long Haul COVID Long-Haul COVID-19

Interventions

Endourage Targeted Wellness Formula C™, a full hemp flower extractCOMBINATION_PRODUCT

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.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Endourage, LLC

Denver, Colorado, United States

Outcomes

Primary Outcomes

Symptom and wellbeing change over 3 months

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.

Time frame: 90 days

Secondary Outcomes

Patient Global Impression of Change

The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment.

Time frame: 90 days

Data from ClinicalTrials.gov

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