Study to Evaluate Benefits & Safety of Endourage Formula C™ Oral Drops in People With Post-Acute COVID-19 Syndrome.

NCT04828668 | Completed

• 1 other identifier: ENDO-402-2021
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study will explore the contribution of CBD oral drops in persons experiencing symptoms of Post Acute COVID Syndrome or "PACS".

Conditions

Covid 19

Outcome Measures

Primary Outcomes (2)

• Reduction in patient reported outcomes measures on the Patient Reported Outcomes Measurement Information System (PROMIS ®) assessment tools.

  PROMIS® is a set of patient-centered instruments used to measure various patient reported outcomes. Measures are scored on the T-score metric of which 50 is the mean of a relevant baseline population with 10 being the standard deviation of that population. A score of 40 is one stndard deviation less than and a score of 60 is one standard deviation greater than the mean of the baseline or reference population. High scores suggest more of what is being measured (e.g., more fatigue, more shortness of breath) and a lower score suggest improvement in symptoms or complaints assessed depending on symptom or complaint being measured.

  56-days (designated time points)

• PATIENT GLOBAL IMPRESSION OF CHANGE (PGIC)

  This scale evaluates various aspects of patients' health and assesses if there has been an improvement or decline in clinical status. Scale associated with subjective responses range 1-7 (from no change or a one through a great deal better and considerable improvement that has made all the difference or a seven), higher ratings indicate improved sympomtoms (responders) versus those reporting lower scores suggesting no change or a worsening of their condition (non-responders).

  56-days (designated time points)

Secondary Outcomes (1)

• Study product related adverse events and side effects.

  56-days (designated time points)

Study Arms (2)

Formula C

EXPERIMENTAL

30 participants will be randomized to masked active study product (Formula C) for 28-days; they will continue to the open label extension phase (with commercially available product for an additional 28-days when they will receive commercially available product.

Dietary Supplement: Targeted Wellness Formula C™ Sublingual Drops - 1200mg - 30 mL (Formula C)

Placebo

PLACEBO COMPARATOR

30 participants will be randomized to placebo for 28-days; they will roll-over to the open label extension phase of study product (Formula C) for an additional 28-days when they will receive commercially available product.

Dietary Supplement: Targeted Wellness Formula C™ Sublingual Drops - 1200mg - 30 mL (Formula C)

Interventions

Targeted Wellness Formula C™ Sublingual Drops - 1200mg - 30 mL (Formula C) DIETARY_SUPPLEMENT

Hemp seed oil

Also known as: Placebo

Formula C; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years of age or older who can provide informed consent.
• Persons who have been diagnosed with COVID-19 and now in post-acute recovery phase.
• Persons who are in care with access to primary care for post COVID infection or PACS.
• Ability to read and write in the English language and follow study-related procedures.
• Ability to have mail/ study drug delivered to an address and/or P.O. Box in the recipient's name.
• Ability to participate in telemedicine visits/communication.
• If a woman of childbearing age, willing to use a dual method of contraception (barrier and/or hormonal).

You may not qualify if:

• Active illicit or non-prescribed drug use.
• Concomitant use of benzodiazepines.
• Concomitant use of an immune suppressant agent, e.g., prednisone.
• Documented history and active treatment for seizure disorder.
• Transaminase elevation.
• Active autoimmune disorder.
• Hepatitis C infection (currently on therapy and/or any transaminitis elevation).
• Hepatitis B infection (currently on therapy and/or any transaminitis elevation).
• Human Immune Deficiency Virus (HIV-1 or HIV-2) infection that is newly diagnosed or untreated.
• Any form of mental impairment that will/could hinder safe participation in the study.
• Pregnancy or breast-feeding.
• Any condition that in the opinion of the investigator would be harmful or detrimental to the participant.

Sponsors & Collaborators

• Endourage, LLC: lead

Study Sites (1)

Thomas P Young

Novato, California, 94945, United States

Location

Related Publications (3)

• Lu D, Vemuri VK, Duclos RI Jr, Makriyannis A. The cannabinergic system as a target for anti-inflammatory therapies. Curr Top Med Chem. 2006;6(13):1401-26. doi: 10.2174/15680266106061401.

  PMID: 16918457 BACKGROUND

• Moreira FA, Lutz B. The endocannabinoid system: emotion, learning and addiction. Addict Biol. 2008 Jun;13(2):196-212. doi: 10.1111/j.1369-1600.2008.00104.x. Epub 2008 Apr 16.

  PMID: 18422832 BACKGROUND

• 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 DERIVED

Related Links

• COVID-19 Testing
• COVID-19 WHO
• COVID-19 Infectious Disease Society of America (IDSA)

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Thomas P Young, PhD, NP

  JOEL S ERICKSON, MD & THOMAS P YOUNG, PHD NP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Treatment period 1 will utilize masked study product labels with subject ID. Treatment period 1 will utilized unmasked / open-label study product with subject ID.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A total of 60 (sixty) participants who meet inclusion and exclusion criteria will be randomized and enrolled in a 1:1 ratio of study product (Formula C) vs. placebo. Group 1: 30 participants will be randomized to masked active study product (Formula C) for 28-days; they will continue to the open label extension phase (with commercially available product for an additional 28-days when they will receive commercially available product. Group 2: 30 participants will be randomized to placebo for 28-days; they will roll-over to the open label extension phase of study product (Formula C) for an additional 28-days when they will receive commercially available product. At the completion of the treatment period, the participants will be followed for 14-days.

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: April 2, 2021
• Study Start: April 2, 2021
• Primary Completion: January 31, 2022
• Study Completion: February 14, 2022
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)