Covid19 Positive PatientNCT04486144
Impact Nerium Oleander on Immune Function
A study testing Proprietary extract of Nerium oleander in people with Covid19 Positive Patient and Covid19 Close Contact, run by HealthQuilt at 1 site in United States.
Trial summary
Assess the impact of a proprietary extract of Nerium oleander on immune function as evidenced by COVID-19 symptoms and mortality in COVID-19 positive patients and their close contacts compared to controls that did not receive the extract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19 Positive Patient, Covid19 Close Contact, Immune Function
- What is being tested?
- Proprietary extract of Nerium oleander
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2020to 23 Jul 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18
- COVID 19 positive or close contact of COVID 19 positive
- No use of cardiac glycosides or other antiarrhythmic medications
Who cannot join
- No use of cardiac glycosides or other antiarrhythmic medications
- No allergy to coconut oil
Trial locations and contacts
1 site in 1 country.
United States1 site
KDunn and Associates, PA, dba Healthquilt
Houston, Texas, 77055
About this study
Official title: Impact of a Proprietary Extract of Nerium Oleander on Immune Function as Evidenced by Clinical Symptoms and Mortality :A Feasibility Study
Assess the impact of a proprietary extract of Nerium oleander on immune function as evidenced by COVID-19 symptoms and mortality in COVID-19 positive patients and their close contacts compared to controls that did not receive the extract.
Read the detailed description
This is an exploratory study based on positive in-vitro, and in-vivo (humans) that appear to support an immune function benefit. Up to 100 patients that are COVID-19 positive in the ambulatory setting will be invited to participate. After informed consent is obtained, patients will be in either the Intervention Group (receive extract) or Comparison Group (did not receive extract). A baseline assessment and record review will be conducted to assure eligibility criteria. Patients in the Intervention Group will be given .5 ml (6.25 mg of extract) every 6 hours for 5 days, total of 25 mg per day / 125 mg for 5 days. Patient vital signs (temperature, pulse oximetry, blood pressure) and CDC symptoms / side effects will also be tracked. A dedicated medical oversight team with 24 / 7 access to care will be provided to monitor safety and tolerance. Patients will be followed for 10 days. Baseline antibody, RT-PCR, and live virus will be collected on Day 1, Day 5, and Day 10. A Data Monitoring Committee at the Schull Institute will meet weekly to review data.
- Being tested
- Proprietary extract of Nerium oleander
- Keywords
- Covid19, Nerium oleander, Clinical symptoms, Mortality, Immune Function
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprietary extract of Nerium oleanderOther
This is a proprietary extract of Nerium oleander that is 6.25 ug per 0.5 ml of suspension. It is administered sublingually every six hours for 5 days. The daily dose is 25 ug and the 5 day dose is 125 ug.
| Study group | Role | What they receive |
|---|---|---|
| COVID19 Positive: Intervention Group (Receive extract) | Experimental | These are patients that are COVID19 positive who elect to try the extract. Receives: Other: Proprietary extract of Nerium oleander |
| COVID19 Positive: Comparison Group (Do NOT receive extract) | No intervention | These are patients that are COVID19 positive who do NOT elect to try the extract |
| COVID19 Exposed: Intervention Group (Receive extract) | Experimental | These are patients that are COVID19 negative at the start, live with a COVID19 positive patient and who elect to try the extract. Receives: Other: Proprietary extract of Nerium oleander |
| COVID19 Exposed: Comparison Group (Do NOT receive extract) | No intervention | These are patients that are COVID19 negative at the start, live with a COVID19 positive patient and who elect to NOT try the extract. |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID19 symptoms
The CDC list of symptoms and "other".
Measured: Every 6 hours for 10 days
Mortality
A patient in any arm that dies.
Measured: 10 days from enrollment into the Study, e.g. Day 10
Secondary outcomes (2)
COVID19 Live Virus
COVID19 Live Virus Nasopharyngeal swab performed by UTMB, Texas
Measured: Day 1, Day 5, Day 10
RT-PCR COVID19 Test
RT-PCR Nasopharyngeal swab performed by Fulgent, California
Measured: Day 1, Day 5, Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start20 May 2020
- Primary completion23 Jul 2020
- Study completion23 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19 Positive PatientStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthQuilt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kim Dunn, MD, Ph.D., Principal investigator, KDunn and Associates, PA dba Healthquilt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486144
- Sponsor's protocol ID
- 052020
- Status last verified
- Apr 2021
- First submitted
- 20 Jul 2020
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: KDunn and Associates, PA will de-identify data and archive it at The Schull Institute Data Archive at the University of Texas School of Biomedical Informatics after the Summer Research Program Conclusion.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Proprietary Extract of Nerium Oleander on Immune Function as Evidenced by Clinical Symptoms and Mortality :A Feasibility Study
- ClinicalTrials.gov ID
- NCT04486144
- Acronym / sponsor ID
- 052020
- Keywords
- Covid19, Nerium oleander, Clinical symptoms, Mortality, Immune Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- HealthQuiltUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 23 Jul 2020 (actual)
- Study completion
- 23 Jul 2020 (actual)
- First posted
- 24 Jul 2020 (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.
Assess the impact of a proprietary extract of Nerium oleander on immune function as evidenced by COVID-19 symptoms and mortality in COVID-19 positive patients and their close contacts compared to controls that did not receive the extract.
Detailed description
This is an exploratory study based on positive in-vitro, and in-vivo (humans) that appear to support an immune function benefit. Up to 100 patients that are COVID-19 positive in the ambulatory setting will be invited to participate. After informed consent is obtained, patients will be in either the Intervention Group (receive extract) or Comparison Group (did not receive extract). A baseline assessment and record review will be conducted to assure eligibility criteria. Patients in the Intervention Group will be given .5 ml (6.25 mg of extract) every 6 hours for 5 days, total of 25 mg per day / 125 mg for 5 days. Patient vital signs (temperature, pulse oximetry, blood pressure) and CDC symptoms / side effects will also be tracked. A dedicated medical oversight team with 24 / 7 access to care will be provided to monitor safety and tolerance. Patients will be followed for 10 days. Baseline antibody, RT-PCR, and live virus will be collected on Day 1, Day 5, and Day 10. A Data Monitoring Committee at the Schull Institute will meet weekly to review data.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| COVID19 Positive: Intervention Group (Receive extract) | Experimental | Other: Proprietary extract of Nerium oleanderThese are patients that are COVID19 positive who elect to try the extract. |
| COVID19 Positive: Comparison Group (Do NOT receive extract) | No intervention | –These are patients that are COVID19 positive who do NOT elect to try the extract |
| COVID19 Exposed: Intervention Group (Receive extract) | Experimental | Other: Proprietary extract of Nerium oleanderThese are patients that are COVID19 negative at the start, live with a COVID19 positive patient and who elect to try the extract. |
| COVID19 Exposed: Comparison Group (Do NOT receive extract) | No intervention | –These are patients that are COVID19 negative at the start, live with a COVID19 positive patient and who elect to NOT try the extract. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18
- COVID 19 positive or close contact of COVID 19 positive
- No use of cardiac glycosides or other antiarrhythmic medications
Key exclusion criteria (2 listed)
- No use of cardiac glycosides or other antiarrhythmic medications
- No allergy to coconut oil
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 |
|---|---|---|
| Proprietary extract of Nerium oleanderThis is a proprietary extract of Nerium oleander that is 6.25 ug per 0.5 ml of suspension. It is administered sublingually every six hours for 5 days. The daily dose is 25 ug and the 5 day dose is 125 ug. | Other | COVID19 Exposed: Intervention Group (Receive extract), COVID19 Positive: Intervention Group (Receive extract) |
Primary outcome
COVID19 symptoms
Time frame: Every 6 hours for 10 days
The CDC list of symptoms and "other".
Mortality
Time frame: 10 days from enrollment into the Study, e.g. Day 10
A patient in any arm that dies.
2 secondary outcomes
COVID19 Live Virus
Time frame: Day 1, Day 5, Day 10
RT-PCR COVID19 Test
Time frame: Day 1, Day 5, Day 10
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 22 Apr 2021.
- Plante KS, Plante JA, Fernandez D, et al. Prophylactic and therapeutic inhibition of in vitro SARS-CoV-2 replication by Oleandrin. bioRxiv. July 15, 2020. Cold Spring Harbor Laboratory.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. KDunn and Associates, PA will de-identify data and archive it at The Schull Institute Data Archive at the University of Texas School of Biomedical Informatics after the Summer Research Program Conclusion.
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.
Kim Dunn, MD, Ph.D. principal investigator
KDunn and Associates, PA dba Healthquilt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprietary extract of Nerium oleander in people with Covid19 Positive Patient and Covid19 Close Contact, run by HealthQuilt 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 3 inclusion and 2 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 22 Apr 2021. 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?
COVID19 symptoms (time frame: Every 6 hours for 10 days). 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?
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 22 Apr 2021; AzTrials last refreshed its copy on 5 Nov 2026.