Long COVIDNCT06163690
Symptom Tracking in Long COVID Patients Using Formula C™ Sublingual Drops
An observational study of Long COVID and Long Covid19, run by Endourage, LLC at 1 site in United States.
Trial summary
This is a digital symptom tracking study of Formula C™, a full cannabis flower formulation, rich in cannabinoids and terpenes, that has been shown to improve symptoms in people with Long COVID. Participants 21 and older will take Formula C™ for 90 days. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Long COVID, Long Covid19, Post-Acute COVID-19
- What is being tested?
- Endourage Targeted Wellness Formula C™, a full hemp flower extract
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2023to 31 Jan 2025
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People located in the U.S. that have been diagnosed with Long COVID and are being treated by a physician for Long COVID symptoms.
Who may be able to join
- Must be at least 21 years of age.
- Willing and able to read, understand, and sign the informed consent.
- Willing to comply with all study procedures.
- Must have device to access the internet to complete surveys online.
- A diagnosis of Long COVID from a health care provider.
Who cannot join
- Non-English speaking, as the surveys are developed in the English language.
- Known allergies to hemp seeds or hemp-derived products, medical cannabis, coconut oil.
- Pregnancy, or planning to become pregnant in the next 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Symptom Tracking and Wellness in Long COVID Patients Using Endourage Targeted Wellness Formula C™ Sublingual Drops
This is a digital symptom tracking study of Formula C™, a full cannabis flower formulation, rich in cannabinoids and terpenes, that has been shown to improve symptoms in people with Long COVID. Participants 21 and older will take Formula C™ for 90 days. During that time, participants will answer weekly surveys to track symptoms and wellbeing.
Read the detailed description
Long COVID is a global health crisis with no current treatments. There's a growing interest within the medical community to explore the potential benefits of full hemp flower extracts in treating and alleviating Long COVID symptoms. Full hemp flower extracts are a remarkable advancement in the field of natural wellness and healing. Full hemp flower extracts harness the full spectrum of beneficial compounds present in the hemp plant, including not just cannabidiol (CBD), but a host of other cannabinoids, terpenes, and flavonoids. This process, known as 'whole plant' or 'full spectrum' extraction, produces a more potent and therapeutic product, as the various compounds work synergistically in what is referred to as the 'entourage effect'. These extracts have been associated with a broad range of potential health benefits, such as pain relief, reduction of inflammation, anxiety management, and sleep improvement. A recently published single-blind, randomized, placebo controlled trial demonstrated that Long COVID patients benefitted from sublingual use of Formula C without any safety events. This remote, observational study of Endourage Targeted Wellness Formula C™ sublingual drops will seek to empower participants to track symptoms and wellbeing while taking Formula C to determine if Long COVID symptoms are attenuated and time to healing is shortened.
- Conditions
- Long COVID, Long Covid19, Post-Acute COVID-19, Post-Acute COVID-19 Syndrome, Long Haul COVID, Long-Haul COVID-19
- Being tested
- Endourage Targeted Wellness Formula C™, a full hemp flower extract
- Keywords
- Hemp, Terpenes, Cannabinoids, Entourage effect
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endourage Targeted Wellness Formula C™, a full hemp flower extractCombination product
A hemp-derived formulation designed as a daily use adjunctive therapy to help improve Long COVID symptoms. Endourage Targeted Wellness Formula C™ are used as sublingual drops held under the tongue for 60 to 90 seconds.
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom and wellbeing change over 3 months
This study will use the PROMIS-29+2 Profile v2.1 (PROPr) is used to calculate a change in Long COVID related symptoms including fatigue, sleep, pain, mood and physical function.
Measured: 90 days
Secondary outcomes (1)
Patient Global Impression of Change
The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start13 Dec 2023
- Primary completion2 Dec 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Long COVIDStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endourage, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Steward, MD, Principal investigator, Endourage, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163690
- Sponsor's protocol ID
- Endo2023
- Status last verified
- Oct 2024
- First submitted
- 7 Dec 2023
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 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 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Symptom Tracking and Wellness in Long COVID Patients Using Endourage Targeted Wellness Formula C™ Sublingual Drops
- ClinicalTrials.gov ID
- NCT06163690
- Acronym / sponsor ID
- Endo2023
- Conditions
- Long COVID, Long Covid19, Post-Acute COVID-19, Post-Acute COVID-19 Syndrome, Long Haul COVID, Long-Haul COVID-19
- Keywords
- Hemp, Terpenes, Cannabinoids, Entourage effect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Endourage, LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 11 Dec 2023 (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 is a digital symptom tracking study of Formula C™, a full cannabis flower formulation, rich in cannabinoids and terpenes, that has been shown to improve symptoms in people with Long COVID. Participants 21 and older will take Formula C™ for 90 days. During that time, participants will answer weekly surveys to track symptoms and wellbeing.
Detailed description
Long COVID is a global health crisis with no current treatments. There's a growing interest within the medical community to explore the potential benefits of full hemp flower extracts in treating and alleviating Long COVID symptoms. Full hemp flower extracts are a remarkable advancement in the field of natural wellness and healing. Full hemp flower extracts harness the full spectrum of beneficial compounds present in the hemp plant, including not just cannabidiol (CBD), but a host of other cannabinoids, terpenes, and flavonoids. This process, known as 'whole plant' or 'full spectrum' extraction, produces a more potent and therapeutic product, as the various compounds work synergistically in what is referred to as the 'entourage effect'. These extracts have been associated with a broad range of potential health benefits, such as pain relief, reduction of inflammation, anxiety management, and sleep improvement. A recently published single-blind, randomized, placebo controlled trial demonstrated that Long COVID patients benefitted from sublingual use of Formula C without any safety events. This remote, observational study of Endourage Targeted Wellness Formula C™ sublingual drops will seek to empower participants to track symptoms and wellbeing while taking Formula C to determine if Long COVID symptoms are attenuated and time to healing is shortened.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People located in the U.S. that have been diagnosed with Long COVID and are being treated by a physician for Long COVID symptoms.
Key inclusion criteria (5 listed)
- Must be at least 21 years of age.
- Willing and able to read, understand, and sign the informed consent.
- Willing to comply with all study procedures.
- Must have device to access the internet to complete surveys online.
- A diagnosis of Long COVID from a health care provider.
Key exclusion criteria (3 listed)
- Non-English speaking, as the surveys are developed in the English language.
- Known allergies to hemp seeds or hemp-derived products, medical cannabis, coconut oil.
- Pregnancy, or planning to become pregnant in the next 3 months
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 |
|---|---|---|
| Endourage Targeted Wellness Formula C™, a full hemp flower extractA hemp-derived formulation designed as a daily use adjunctive therapy to help improve Long COVID symptoms. Endourage Targeted Wellness Formula C™ are used as sublingual drops held under the tongue for 60 to 90 seconds. | Combination product | – |
Primary outcome
Symptom and wellbeing change over 3 months
Time frame: 90 days
This study will use the PROMIS-29+2 Profile v2.1 (PROPr) is used to calculate a change in Long COVID related symptoms including fatigue, sleep, pain, mood and physical function.
1 secondary outcome
Patient Global Impression of Change
Time frame: 90 days
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 25 Feb 2025.
- Background: 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.
- Individual participant dataSharing planned: No
Related trials for Long COVID
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Not yet recruitingPhase 3
Dapagliflozin for Long COVID Syndrome
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Long COVID Brain Fog: Cognitive Rehabilitation Trial
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RecruitingPhase 2
SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction
Post-acute Sequelae of COVID-19, Long COVID
Enrolling by invitation
Fareon Open Label Device Clinical Trial
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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.
Michael Steward, MD principal investigator
Endourage, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long COVID and Long Covid19, 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 5 inclusion and 3 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 25 Feb 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. 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?
Symptom and wellbeing change over 3 months (time frame: 90 days). 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 NCT06163690, which also lists 1 linked publication.
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 25 Feb 2025.