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

("BAC-PAC" Trial)

Recruiting at 1 trial location

Overseen By Morgan L Dewing, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Endourage, LLC

Must not be taking: Benzodiazepines, Immune suppressants

Disqualifiers: Seizure disorder, Autoimmune disorder, Hepatitis, others

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

32 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You may need to stop taking certain medications, like benzodiazepines or immune suppressants, to join this trial. The protocol doesn't mention other specific medications, so it's best to discuss your current meds with the study team.

What safety data exists for Targeted Wellness Formula C™ Sublingual Drops or similar treatments?

A study on Coleus forskohlii extract, a similar herbal ingredient, found that 10.5% of users experienced adverse events, mostly gastrointestinal issues like diarrhea. The safe intake amount was estimated to be less than 250 mg/day. ^{1 2 3 4 5}

How does Targeted Wellness Formula C™ Sublingual Drops differ from other treatments?

Targeted Wellness Formula C™ Sublingual Drops may offer a unique administration route as sublingual (under the tongue) delivery, which can allow for faster absorption compared to traditional oral tablets. This method can be particularly beneficial for individuals who have difficulty swallowing pills or require rapid onset of action. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial is testing CBD oral drops to help people with Post Acute COVID Syndrome (PACS), also known as long-haulers syndrome. Conventional treatments haven't worked well for these patients, so researchers are exploring CBD as an alternative. CBD might help by reducing inflammation and pain, potentially improving symptoms. CBD (cannabidiol) is a naturally occurring molecule derived from cannabis, known for its anti-inflammatory and antiviral properties, and has been proposed as a potential treatment for COVID-19.

Research Team

Thomas P Young, PhD, NP

Principal Investigator

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

Eligibility Criteria

Inclusion Criteria

Ability to participate in telemedicine visits/communication.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either placebo or Formula C for 28 days

4 weeks

Weekly telemedicine visits

Open-label extension

Participants receive commercially available Formula C for an additional 28 days

4 weeks

Weekly telemedicine visits

Follow-up

Participants are monitored for continued benefit and/or re-emergence of symptoms/relapse

2 weeks

7-day and 14-day telemedicine visits

Treatment Details

Interventions

• Targeted Wellness Formula C™ Sublingual Drops

Participant Groups

Group I: Formula C Experimental Treatment 1 Intervention

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 II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Endourage, LLC

Lead Sponsor

Trials

4

Recruited

160+

Findings from Research

The proposed three-part framework for analyzing adverse events includes phases for documenting incidents, conducting in-depth reviews, and assessing the association between exposure and adverse events, which can enhance product safety.

By standardizing the evaluation of adverse events through this framework, companies can better manage risks and improve consumer products based on reliable data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-market surveillance of consumer products: Framework for adverse event management. Kingston, R., Sioris, K., Gualtieri, J., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Post-market surveillance of consumer products: Framework for adverse event management. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Nationwide Online Survey Enables the Reevaluation of the Safety of Coleus forskohlii Extract Intake Based on the Adverse Event Frequencies. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Regulatory alerts for dietary supplements in Canada and the United States, 2005-13. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Warfarin and food, herbal or dietary supplement interactions: A systematic review. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Vomiting from multivitamins: a potential drug interaction. [2014]

6. United States pubmed.ncbi.nlm.nih.gov

Preclinical Pharmacokinetic Study on Caffeine as an Excipient for Monoclonal Antibody Formulations. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Systematic Development of Self-Nanoemulsifying Liquisolid Tablets to Improve the Dissolution and Oral Bioavailability of an Oily Drug, Vitamin K1. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Self-Nanoemulsifying Lyophilized Tablets for Flash Oral Transmucosal Delivery of Vitamin K: Development and Clinical Evaluation. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of food intake and co-administration of placebo self-nanoemulsifying drug delivery systems on the absorption of cinnarizine in healthy human volunteers. [2016]

10. Germany pubmed.ncbi.nlm.nih.gov

Toxicity Study of a Self-nanoemulsifying Drug Delivery System Containing N-methyl pyrrolidone. [2022]