CBD Oral Drops for Long COVID

("BAC-PAC" Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the benefits and safety of CBD oral drops for individuals experiencing ongoing symptoms after recovering from COVID-19, known as Post-Acute COVID Syndrome (PACS). Participants will receive either the CBD formula (Targeted Wellness Formula C™ Sublingual Drops) or a placebo (a substance with no active ingredients) for 28 days, followed by an additional 28 days where all participants receive the actual CBD drops. This trial suits individuals who have had COVID-19, are in the recovery phase, and experience ongoing symptoms affecting daily life. Participants must be able to engage in telemedicine and receive study materials by mail.

As an unphased trial, this study provides a unique opportunity to contribute to understanding the potential benefits of CBD for PACS.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Formula C, a CBD oral drop, appears safe for individuals with post-acute COVID-19 syndrome (PACS). In earlier studies, participants using Formula C experienced no negative side effects. The drops are easy to use and have been sold commercially, indicating they are generally well-tolerated. It is important to note that taking less than 250 mg per day is considered safe. Overall, evidence suggests that Formula C is safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Post-Acute COVID-19 Syndrome, which often focus on symptom management through medications like steroids, anticoagulants, or rehabilitation therapies, Formula C™ stands out with its novel approach. This treatment uses sublingual drops, allowing for potentially faster absorption and quicker onset of action. Researchers are particularly excited about its targeted wellness formula, which aims to enhance recovery by addressing underlying biological processes rather than just alleviating symptoms. This innovative method could offer a more holistic benefit for those struggling with long-term effects of COVID-19.

What evidence suggests that Targeted Wellness Formula C™ Sublingual Drops might be an effective treatment for Post Acute COVID Syndrome?

Research suggests that Targeted Wellness Formula C™ Sublingual Drops might alleviate symptoms of Post Acute COVID Syndrome (PACS), also known as long COVID. Previous studies have shown that people using Formula C reported improvements, as measured by tools like the PGIC and PROMIS scores, which assess patients' perceptions of their symptoms and overall health. Additionally, a 90-day symptom tracking study demonstrated positive results in managing long COVID symptoms with these CBD oral drops. In this trial, participants will receive either Formula C or a placebo for 28 days, followed by an open-label extension phase. Overall, promising evidence indicates that Formula C™ could help relieve some symptoms associated with PACS. ^{1 3 4 5 6}

Who Is on the Research Team?

Thomas P Young, PhD, NP

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Targeted Wellness Formula C™ Sublingual Drops

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36252151/

A Single-Blind, Randomized, Placebo Controlled Study to ... The study showed symptom improvement for PACS participants using Formula C, and both groups showed improvement, suggesting non-CBD formulations ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06163690

Symptom Tracking in Long COVID Patients Using Formula ... This study tracks Long COVID symptoms in participants using Formula C™ sublingual drops, a full hemp flower extract, over 90 days, using weekly surveys.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04828668

Study to Evaluate Benefits & Safety of Endourage Formula ... This study will explore the contribution of CBD oral drops in persons experiencing symptoms of Post Acute COVID Syndrome or "PACS".

4. liebertpub.com liebertpub.com/doi/full/10.1089/can.2022.0135?doi=10.1089/can.2022.0135

A Single-Blind, Randomized, Placebo Controlled Study to ... Results: Twenty-four participants completed study, with 8 withdrawals, none related to study product. PGIC and PROMIS scores improved across both groups at day ...

5. withpower.com withpower.com/trial/phase-covid-19-3-2021-5b10d

Study to Evaluate Benefits & Safety of Endourage Formula ... This trial is testing CBD oral drops to help people with Post Acute COVID Syndrome (PACS), also known as long-haulers syndrome.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06163690?term=Formula%20C&rank=4

Symptom Tracking in Long COVID Patients Using Formula ... This remote, observational study of Endourage Targeted Wellness Formula C™ sublingual drops will seek to empower participants to track symptoms and wellbeing ...