Covid 19"BAC-PAC"NCT04828668
Study to Evaluate Benefits & Safety of Endourage Formula C™ Oral Drops in People With Post-Acute COVID-19 Syndrome.
A study testing Targeted Wellness Formula C™ Sublingual Drops - 1200mg - 30 mL (Formula C) in people with Covid 19, run by Endourage, LLC at 1 site in United States.
Trial summary
This study will explore the contribution of CBD oral drops in persons experiencing symptoms of Post Acute COVID Syndrome or "PACS". Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid 19
- What is being tested?
- Targeted Wellness Formula C™ Sublingual Drops - 1200mg - 30 mL (Formula C)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2021to 14 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
This study will explore the contribution of CBD oral drops in persons experiencing symptoms of Post Acute COVID Syndrome or "PACS".
Read the 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.
- Conditions
- Covid 19
- Being tested
- Targeted Wellness Formula C™ Sublingual Drops - 1200mg - 30 mL (Formula C)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Wellness Formula C™ Sublingual Drops - 1200mg - 30 mL (Formula C)Dietary supplement
Also called Placebo
Hemp seed oil
| Study group | Role | What they receive |
|---|---|---|
| Formula C | Experimental | 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. Receives: Dietary Supplement: Targeted Wellness Formula C™ Sublingual Drops - 1200mg - 30 mL (Formula C) |
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Targeted Wellness Formula C™ Sublingual Drops - 1200mg - 30 mL (Formula C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 56-days (designated time points)
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).
Measured: 56-days (designated time points)
Secondary outcomes (1)
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.
Measured: 56-days (designated time points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start2 Apr 2021
- Primary completion31 Jan 2022
- Study completion14 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid 19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endourage, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas P Young, PhD, NP, Principal investigator, JOEL S ERICKSON, MD & THOMAS P YOUNG, PHD NP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828668
- Sponsor's protocol ID
- ENDO-402-2021
- Acronym
- "BAC-PAC"
- Status last verified
- Aug 2025
- First submitted
- 10 Mar 2021
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16918457Moreira 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.
PubMed 18422832Young 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.
PubMed 36252151
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT04828668
- Acronym / sponsor ID
- "BAC-PAC" / ENDO-402-2021
- Conditions
- Covid 19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Endourage, LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Formula C | Experimental | Dietary Supplement: Targeted Wellness Formula C™ Sublingual Drops - 1200mg - 30 mL (Formula C)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. |
| Placebo | Placebo comparator | Dietary Supplement: Targeted Wellness Formula C™ Sublingual Drops - 1200mg - 30 mL (Formula C)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted Wellness Formula C™ Sublingual Drops - 1200mg - 30 mL (Formula C)Also: PlaceboHemp seed oil | Dietary supplement | Formula C, Placebo |
Primary outcome
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.
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).
1 secondary outcome
Study product related adverse events and side effects.
Time frame: 56-days (designated time points)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Background: PubMed 16918457Lu 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.
- Background: PubMed 18422832Moreira 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.
- Derived from this study: PubMed 36252151Young 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.
- COVID-19 WHOLink provided by the sponsor.
- COVID-19 Infectious Disease Society of America (IDSA)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas P Young, PhD, NP principal investigator
JOEL S ERICKSON, MD & THOMAS P YOUNG, PHD NP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Wellness Formula C™ Sublingual Drops - 1200mg - 30 mL (Formula C) in people with Covid 19, run by Endourage, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in patient reported outcomes measures on the Patient Reported Outcomes Measurement Information System (PROMIS ®) assessment tools. (time frame: 56-days (designated time points)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04828668, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.