- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04486144
Impact Nerium Oleander on Immune Function
April 20, 2021 updated by: HealthQuilt
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
82
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77055
- KDunn and Associates, PA, dba Healthquilt
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18
- COVID 19 positive or close contact of COVID 19 positive
- No use of cardiac glycosides or other antiarrhythmic medications
Exclusion Criteria:
- No use of cardiac glycosides or other antiarrhythmic medications
- No allergy to coconut oil
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: COVID19 Positive: Intervention Group (Receive extract)
These are patients that are COVID19 positive who elect to try the extract.
|
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.
|
No Intervention: COVID19 Positive: Comparison Group (Do NOT receive extract)
These are patients that are COVID19 positive who do NOT elect to try the extract
|
|
Experimental: COVID19 Exposed: Intervention Group (Receive extract)
These are patients that are COVID19 negative at the start, live with a COVID19 positive patient and who elect to try the extract.
|
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.
|
No Intervention: COVID19 Exposed: Comparison Group (Do NOT receive extract)
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COVID19 symptoms
Time Frame: Every 6 hours for 10 days
|
The CDC list of symptoms and "other".
|
Every 6 hours for 10 days
|
Mortality
Time Frame: 10 days from enrollment into the Study, e.g. Day 10
|
A patient in any arm that dies.
|
10 days from enrollment into the Study, e.g. Day 10
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COVID19 Live Virus
Time Frame: Day 1, Day 5, Day 10
|
COVID19 Live Virus Nasopharyngeal swab performed by UTMB, Texas
|
Day 1, Day 5, Day 10
|
RT-PCR COVID19 Test
Time Frame: Day 1, Day 5, Day 10
|
RT-PCR Nasopharyngeal swab performed by Fulgent, California
|
Day 1, Day 5, Day 10
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kim Dunn, MD, Ph.D., KDunn and Associates, PA dba Healthquilt
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 20, 2020
Primary Completion (Actual)
July 23, 2020
Study Completion (Actual)
July 23, 2020
Study Registration Dates
First Submitted
July 20, 2020
First Submitted That Met QC Criteria
July 22, 2020
First Posted (Actual)
July 24, 2020
Study Record Updates
Last Update Posted (Actual)
April 22, 2021
Last Update Submitted That Met QC Criteria
April 20, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 052020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
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.
IPD Sharing Time Frame
October 2020
IPD Sharing Access Criteria
Need to have a specific question or plan to study further.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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