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

February 16, 2024 updated by: Endourage, LLC

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 COVID-19 Syndrome (PACS).

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

At present, conventional medical and rehabilitation therapies have not consistently been effective for people with PACS, and in fact some symptoms have been observed to worsen over time. This inconsistency in clinical response has created a need for alternative treatment options to be explored. CBD presents a novel approach that warrants further investigation.

After review and approval by an Institutional Review Board (IRB), potential study participants will be recruited from on-line support groups who have identified themselves as persons experiencing post-acute COVID-19 syndrome also known as (long-haulers syndrome).

The study will be registered on the www.clincaltrials.gov website and will accept referrals from targeted clinics who refer their patients to the investigational site listed and individuals can also self-refer to the study center team.

Subjects will be evaluated weekly using telemedicine procedures. At completion of study, there will be a 7-day and 14-day follow up telemedicine visit to assess for continued benefit and/or re-emergence of symptoms/relapse.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Novato, California, United States, 94945
        • Thomas P Young

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Formula C
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)
Hemp seed oil
Other Names:
  • Placebo
Placebo Comparator: Placebo
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)
Hemp seed oil
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in patient reported outcomes measures on the Patient Reported Outcomes Measurement Information System (PROMIS ®) assessment tools.
Time Frame: 56-days (designated time points)

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)
Time Frame: 56-days (designated time points)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study product related adverse events and side effects.
Time Frame: 56-days (designated time points)
Daily diary entries and clinical interview at scheduled visit; the number of participants with treatment related events as measured by grading scale of the Common Terminology Criteria for Adverse Events (CTCAE), grade 1-IV (one through four) and using descriptor terms, mild, moderate, severe. Additionally, any adverse event meeting serious adverse event criteria will be collected and reported. Frequency summary tables of all adverse events/serious adverse events will be tabulated and reported.
56-days (designated time points)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endourage, LLC

Investigators

  • Principal Investigator: Thomas P Young, PhD, NP, JOEL S ERICKSON, MD & THOMAS P YOUNG, PHD NP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2021

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

February 14, 2022

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

April 1, 2021

First Posted (Actual)

April 2, 2021

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDO-402-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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