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OpenTrials
Completed

NCT Number: NCT04828668

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas P Young

Novato, California, 94945, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Dietary Supplement

Hemp seed oil

Other names: Placebo

Primary outcomes

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

    Time frame: 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.

  2. PATIENT GLOBAL IMPRESSION OF CHANGE (PGIC)

    Time frame: 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).

Secondary outcomes

  1. Study product related adverse events and side effects.

    Time frame: 56-days (designated time points)

    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.

Sponsors and collaborators

Lead sponsor

Endourage, LLC

Industry

Registry information

Official study 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).

Acronym: "BAC-PAC"

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 2, 2021
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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