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)

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 56-days (designated time points)

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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