Study to Evaluate Benefits & Safety of Endourage Formula C™ Oral Drops in People With Post-Acute COVID-19 Syndrome. - Clinical Trial for Covid 19 | NCT04828668

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Targeted Wellness Formula C™ Sublingual Drops - 1200mg - 30 mL (Formula C)

About this trial

This is an interventional other trial for Covid 19

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Sites / Locations

Thomas P Young

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Formula C

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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).

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04828668

First Posted

March 10, 2021

Last Updated

September 18, 2022

Sponsor

Endourage, LLC

1. Study Identification

Unique Protocol Identification Number

NCT04828668

Brief Title

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

Acronym

"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).

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

April 2, 2021 (Actual)

Primary Completion Date

January 31, 2022 (Actual)

Study Completion Date

February 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Endourage, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid 19

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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

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.

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Formula C

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Targeted Wellness Formula C™ Sublingual Drops - 1200mg - 30 mL (Formula C)

Other Intervention Name(s)

Placebo

Intervention Description

Hemp seed oil

Primary Outcome Measure Information:

Title

Reduction in patient reported outcomes measures on the Patient Reported Outcomes Measurement Information System (PROMIS ®) assessment tools.

Description

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)

Title

PATIENT GLOBAL IMPRESSION OF CHANGE (PGIC)

Description

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)

Secondary Outcome Measure Information:

Title

Study product related adverse events and side effects.

Description

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.

Time Frame

56-days (designated time points)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas P Young, PhD, NP

Organizational Affiliation

JOEL S ERICKSON, MD & THOMAS P YOUNG, PHD NP

Official's Role

Principal Investigator

Facility Information:

Facility Name

Thomas P Young

City

Novato

State/Province

California

ZIP/Postal Code

94945

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

Citations:

PubMed Identifier

16918457

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.

Results Reference

result

PubMed Identifier

18422832

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.

Results Reference

result

PubMed Identifier

20191092

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.

Results Reference

result

PubMed Identifier

22420307

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):984-93. doi: 10.2174/138945012800675786.

Results Reference

result

PubMed Identifier

28861491

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.2016.0009. eCollection 2016.

Results Reference

result

PubMed Identifier

21532172

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.

Results Reference

result

PubMed Identifier

32784198

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.

Results Reference

result

PubMed Identifier

36252151

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. 2022 Oct 14. doi: 10.1089/can.2022.0135. Online ahead of print.

Results Reference

derived

Links:

URL

https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html

Description

COVID-19 Testing

URL

https://www.abbott.com/BinaxNOW-Test-NAVICA-App.html

Description

COVID-19 Testing

URL

https://www.who.int/emergencies/diseases/novel-coronavirus-2019

Description

COVID-19 WHO

URL

https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/

Description

COVID-19 Infectious Disease Society of America (IDSA)

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

Covid 19

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial