Status:
COMPLETED
Study to Evaluate Benefits & Safety of Endourage Formula C™ Oral Drops in People With Post-Acute COVID-19 Syndrome.
Lead Sponsor:
Endourage, LLC
Conditions:
Covid 19
Eligibility:
All Genders
18-75 years
Phase:
NA
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 inconsis...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04828668
Start Date
April 2 2021
End Date
February 14 2022
Last Update
August 7 2025
Active Locations (1)
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1
Thomas P Young
Novato, California, United States, 94945