Study to Evaluate Benefits & Safety of Endourage Formula C™ Oral Drops in People With Post-Acute COVID-19 Syndrome.

Covid 19 Clinical Trial

— "BAC-PAC"  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04828668
• Other study ID #: ENDO-402-2021
• Status: Completed
• Phase: N/A
• Start date: April 2, 2021
• Est. completion date: February 14, 2022

Study information

• Verified date: September 2022
• Source: Endourage, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 14, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid 19
• COVID-19

Intervention

Dietary Supplement:
• Targeted Wellness Formula C™ Sublingual Drops - 1200mg - 30 mL (Formula C)
Hemp seed oil

Locations

Country	Name	City	State
United States	Thomas P Young	Novato	California

Sponsors (1)

Lead Sponsor	Collaborator
Endourage, LLC

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

Lu D, Vemuri VK, Duclos RI Jr, Makriyannis A. The cannabinergic system as a target for anti-inflammatory therapies. Curr Top Med Chem. 2006;6(13):1401-26. doi: 10.2174/15680266106061401. — View Citation

Moreira FA, Lutz B. The endocannabinoid system: emotion, learning and addiction. Addict Biol. 2008 Jun;13(2):196-212. doi: 10.1111/j.1369-1600.2008.00104.x. Epub 2008 Apr 16. — View Citation

Nagarkatti P, Pandey R, Rieder SA, Hegde VL, Nagarkatti M. Cannabinoids as novel anti-inflammatory drugs. Future Med Chem. 2009 Oct;1(7):1333-49. doi: 10.4155/fmc.09.93. — View Citation

Pini A, Mannaioni G, Pellegrini-Giampietro D, Passani MB, Mastroianni R, Bani D, Masini E. The role of cannabinoids in inflammatory modulation of allergic respiratory disorders, inflammatory pain and ischemic stroke. Curr Drug Targets. 2012 Jun;13(7):984- — View Citation

Ruhaak LR, Felth J, Karlsson PC, Rafter JJ, Verpoorte R, Bohlin L. Evaluation of the cyclooxygenase inhibiting effects of six major cannabinoids isolated from Cannabis sativa. Biol Pharm Bull. 2011;34(5):774-8. doi: 10.1248/bpb.34.774. — View Citation

Russo EB. Clinical Endocannabinoid Deficiency Reconsidered: Current Research Supports the Theory in Migraine, Fibromyalgia, Irritable Bowel, and Other Treatment-Resistant Syndromes. Cannabis Cannabinoid Res. 2016 Jul 1;1(1):154-165. doi: 10.1089/can.2016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in patient reported outcomes measures on the Patient Reported Outcomes Measurement Information System (PROMIS ®) assessment tools.	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.	56-days (designated time points)
Primary	PATIENT GLOBAL IMPRESSION OF CHANGE (PGIC)	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).	56-days (designated time points)
Secondary	Study product related adverse events and side effects.	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.	56-days (designated time points)

External Links

•   COVID-19 Infectious Disease Society of America (IDSA)
•   COVID-19 Testing
•   COVID-19 Testing
•   COVID-19 WHO
•   Long COVID or Post-COVID Conditions