Clinical trial NCT04828668: Study to Evaluate Benefits & Safety of Endourage Formula C™ Oral Drops in People With Post-Acute COVID-19 Syndrome.
Official title: 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid 19
Lead sponsor: Endourage, LLC
Sponsor class: INDUSTRY
First posted: 2021-04-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

Brief summary: This study will explore the contribution of CBD oral drops in persons experiencing symptoms of Post Acute COVID Syndrome or "PACS".

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years of age or older who can provide informed consent.
2. Persons who have been diagnosed with COVID-19 and now in post-acute recovery phase.
3. Persons who are in care with access to primary care for post COVID infection or PACS.
4. Ability to read and write in the English language and follow study-related procedures.
5. Ability to have mail/ study drug delivered to an address and/or P.O. Box in the recipient's name.
6. Ability to participate in telemedicine visits/communication.
7. If a woman of childbearing age, willing to use a dual method of contraception (barrier and/or hormonal).

Exclusion Criteria:

1. Active illicit or non-prescribed drug use.
2. Concomitant use of benzodiazepines.
3. Concomitant use of an immune suppressant agent, e.g., prednisone.
4. Documented history and active treatment for seizure disorder.
5. Transaminase elevation.
6. Active autoimmune disorder.
7. Hepatitis C infection (currently on therapy and/or any transaminitis elevation).
8. Hepatitis B infection (currently on therapy and/or any transaminitis elevation).
9. Human Immune Deficiency Virus (HIV-1 or HIV-2) infection that is newly diagnosed or untreated.
10. Any form of mental impairment that will/could hinder safe participation in the study.
11. Pregnancy or breast-feeding.
12. Any condition that in the opinion of the investigator would be harmful or detrimental to the participant.

Primary outcomes:
measure: Reduction in patient reported outcomes measures on the Patient Reported Outcomes Measurement Information System (PROMIS ®) assessment tools.
timeFrame: 56-days (designated time points)
measure: PATIENT GLOBAL IMPRESSION OF CHANGE (PGIC)
timeFrame: 56-days (designated time points)
Secondary outcomes:
measure: Study product related adverse events and side effects.
timeFrame: 56-days (designated time points)
Other outcomes:
Locations:
city: Novato
country: United States
facility: Thomas P Young
state: California
Study officials:
affiliation: JOEL S ERICKSON, MD & THOMAS P YOUNG, PHD NP
name: Thomas P Young, PhD, NP
role: PRINCIPAL_INVESTIGATOR
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citation: Greenhalgh T, Knight M, A'Court C, Buxton M, Husain L. Management of post-acute covid-19 in primary care. BMJ. 2020 Aug 11;370:m3026. doi: 10.1136/bmj.m3026. No abstract available.
citation: Young TP, Erickson JS, Hattan SL, Guzy S, Hershkowitz F, Steward MD. 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 Coronavirus Disease 2019 Syndrome. Cannabis Cannabinoid Res. 2024 Feb;9(1):282-292. doi: 10.1089/can.2022.0135. Epub 2022 Oct 14.