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).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- PATIENT GLOBAL IMPRESSION OF CHANGE (PGIC)
研究概览
简要总结
This study will explore the contribution of CBD oral drops in persons experiencing symptoms of Post Acute COVID Syndrome or "PACS".
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years of age or older who can provide informed consent.
- •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.
- •Ability to read and write in the English language and follow study-related procedures.
- •Ability to have mail/ study drug delivered to an address and/or P.O. Box in the recipient's name.
- •Ability to participate in telemedicine visits/communication.
- •If a woman of childbearing age, willing to use a dual method of contraception (barrier and/or hormonal).
排除标准
- •Active illicit or non-prescribed drug use.
- •Concomitant use of benzodiazepines.
- •Concomitant use of an immune suppressant agent, e.g., prednisone.
- •Documented history and active treatment for seizure disorder.
- •Transaminase elevation.
- •Active autoimmune disorder.
- •Hepatitis C infection (currently on therapy and/or any transaminitis elevation).
- •Hepatitis B infection (currently on therapy and/or any transaminitis elevation).
- •Human Immune Deficiency Virus (HIV-1 or HIV-2) infection that is newly diagnosed or untreated.
- •Any form of mental impairment that will/could hinder safe participation in the study.
- •Pregnancy or breast-feeding.
- •Any condition that in the opinion of the investigator would be harmful or detrimental to the participant.
结局指标
主要结局
PATIENT GLOBAL IMPRESSION OF CHANGE (PGIC)
时间窗: 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).
Reduction in patient reported outcomes measures on the Patient Reported Outcomes Measurement Information System (PROMIS ®) assessment tools.
时间窗: 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.
次要结局
- Study product related adverse events and side effects.(56-days (designated time points))