Study to Evaluate Benefits & Safety of Endourage Formula C™ Oral Drops in People With Post-Acute COVID-19 Syndrome.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- COVID-19
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: A total of 60 (sixty) participants who meet inclusion and exclusion criteria will be randomized and enrolled in a 1:1 ratio of study product (Formula C) vs. placebo. Group 1: 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 2: 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. At the completion of the treatment period, the participants will be followed for 14-days.Masking: Single (Participant)Masking Description: Treatment period 1 will utilize masked study product labels with subject ID. Treatment period 1 will utilized unmasked / open-label study product with subject ID.Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT04828668
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Thomas P Young, PhD, NP JOEL S ERICKSON, MD & THOMAS P YOUNG, PHD NP
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