Thomas P Young
Novato, California, 94945, United States
NCT Number: NCT04828668
This study will explore the contribution of CBD oral drops in persons experiencing symptoms of Post Acute COVID Syndrome or "PACS".
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Novato, California, 94945, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hemp seed oil
Other names: Placebo
Time frame: 56-days (designated time points)
PROMIS® is a set of patient-centered instruments used to measure various patient reported outcomes.
Measures are scored on the T-score metric of which 50 is the mean of a relevant baseline population with 10 being the standard deviation of that population.
A score of 40 is one stndard deviation less than and a score of 60 is one standard deviation greater than the mean of the baseline or reference population.
High scores suggest more of what is being measured (e.g., more fatigue, more shortness of breath) and a lower score suggest improvement in symptoms or complaints assessed depending on symptom or complaint being measured.
Time frame: 56-days (designated time points)
This scale evaluates various aspects of patients' health and assesses if there has been an improvement or decline in clinical status. Scale associated with subjective responses range 1-7 (from no change or a one through a great deal better and considerable improvement that has made all the difference or a seven), higher ratings indicate improved sympomtoms (responders) versus those reporting lower scores suggesting no change or a worsening of their condition (non-responders).
Time frame: 56-days (designated time points)
Daily diary entries and clinical interview at scheduled visit; the number of participants with treatment related events as measured by grading scale of the Common Terminology Criteria for Adverse Events (CTCAE), grade 1-IV (one through four) and using descriptor terms, mild, moderate, severe. Additionally, any adverse event meeting serious adverse event criteria will be collected and reported. Frequency summary tables of all adverse events/serious adverse events will be tabulated and reported.
Endourage, LLC
Industry
A Single-Blind, Randomized, Placebo Controlled, Study to Evaluate the Benefits and Safety of Endourage Targeted Wellness Formula C™ Sublingual Drops in People With Post -Acute COVID-19 Syndrome (PACS).
Acronym: "BAC-PAC"
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06698549
COVID 19, COVID-19
Miami, Florida, United States
View Trial DetailsNCT04418206
COVID 19, COVID-19
Antibes, Alpes Maritimes, France
View Trial DetailsNCT07029048
COVID 19, COVID-19
Astana, Kazakhstan
View Trial DetailsNCT06968156
COVID 19, COVID-19
Istanbul, Turkey (Türkiye)
View Trial Details