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

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

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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