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

NCT06163690 | Completed

• 1 other identifier: Endo2023
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Global Impression of Change

  90 days

Interventions

Endourage Targeted Wellness Formula C™, a full hemp flower extract COMBINATION_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 Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Endourage, LLC: lead

Study Sites (1)

Endourage, LLC

Denver, Colorado, 80033, United States

Location

Related 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. 2024 Feb;9(1):282-292. doi: 10.1089/can.2022.0135. Epub 2022 Oct 14.

  PMID: 36252151 BACKGROUND

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Steward, MD

  Endourage, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 11, 2023
• Study Start: December 13, 2023
• Primary Completion: December 2, 2024
• Study Completion: January 31, 2025
• Last Updated: February 25, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)