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

Long COVID Clinical Trial

Official title:

Digital Symptom Tracking and Wellness in Long COVID Patients Using Endourage Targeted Wellness Formula C™ Sublingual Drops

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06163690
• Other study ID #: Endo2023
• Status: Recruiting
• Start date: December 13, 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Endourage, LLC
• Contact: Michael Steward, MD
• Phone: (855) 920-7546
• Email: michael[@]endourage.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Long COVID

Intervention

Combination Product:
• Endourage 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.

Locations

Country	Name	City	State
United States	Endourage, LLC	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Endourage, LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. 2022 Oct 14. doi: 10.1089/can.2022.0135. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	90 days
Secondary	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.	90 days