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Cannabinoid

Targeted Wellness Formula C™ Sublingual Drops - 1200mg - 30 mL (Formula C) for Coronavirus ("BAC-PAC" Trial)

N/A
Waitlist Available
Led By Thomas P Young, PhD, NP
Research Sponsored by Endourage, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56-days (designated time points)
Awards & highlights

Summary

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.

Eligible Conditions
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56-days (designated time points)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 56-days (designated time points) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PATIENT GLOBAL IMPRESSION OF CHANGE (PGIC)
Reduction in patient reported outcomes measures on the Patient Reported Outcomes Measurement Information System (PROMIS ®) assessment tools.
Secondary study objectives
Study product related adverse events and side effects.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Formula CExperimental Treatment1 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: PlaceboPlacebo Group1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Targeted Wellness Formula C™ Sublingual Drops - 1200mg - 30 mL (Formula C)
2021
N/A
~40

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Who is running the clinical trial?

Endourage, LLCLead Sponsor
3 Previous Clinical Trials
611 Total Patients Enrolled
Thomas P Young, PhD, NPPrincipal InvestigatorJOEL S ERICKSON, MD & THOMAS P YOUNG, PHD NP
~7 spots leftby Sep 2025
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