Back to resultsImpact Nerium Oleander on Immune Function
Primary Purpose
Covid19 Positive Patient, Covid19 Close Contact, Immune Function
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proprietary extract of Nerium oleander
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 Positive Patient focused on measuring Covid19, Nerium oleander, Clinical symptoms, Mortality, Immune Function
Eligibility Criteria
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
Sites / Locations
- KDunn and Associates, PA, dba Healthquilt
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
No Intervention
Experimental
No Intervention
Arm Label
COVID19 Positive: Intervention Group (Receive extract)
COVID19 Positive: Comparison Group (Do NOT receive extract)
COVID19 Exposed: Intervention Group (Receive extract)
COVID19 Exposed: Comparison Group (Do NOT receive extract)
Arm Description
These are patients that are COVID19 positive who elect to try the extract.
These are patients that are COVID19 positive who do NOT elect to try the extract
These are patients that are COVID19 negative at the start, live with a COVID19 positive patient and who elect to try the 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.
Outcomes
Primary Outcome Measures
COVID19 symptoms
The CDC list of symptoms and "other".
Mortality
A patient in any arm that dies.
Secondary Outcome Measures
COVID19 Live Virus
COVID19 Live Virus Nasopharyngeal swab performed by UTMB, Texas
RT-PCR COVID19 Test
RT-PCR Nasopharyngeal swab performed by Fulgent, California
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04486144
Brief Title
Impact Nerium Oleander on Immune Function
Official Title
Impact of a Proprietary Extract of Nerium Oleander on Immune Function as Evidenced by Clinical Symptoms and Mortality :A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
July 23, 2020 (Actual)
Study Completion Date
July 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthQuilt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19 Positive Patient, Covid19 Close Contact, Immune Function
Keywords
Covid19, Nerium oleander, Clinical symptoms, Mortality, Immune Function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COVID19 Positive: Intervention Group (Receive extract)
Arm Type
Experimental
Arm Description
These are patients that are COVID19 positive who elect to try the extract.
Arm Title
COVID19 Positive: Comparison Group (Do NOT receive extract)
Arm Type
No Intervention
Arm Description
These are patients that are COVID19 positive who do NOT elect to try the extract
Arm Title
COVID19 Exposed: Intervention Group (Receive extract)
Arm Type
Experimental
Arm Description
These are patients that are COVID19 negative at the start, live with a COVID19 positive patient and who elect to try the extract.
Arm Title
COVID19 Exposed: Comparison Group (Do NOT receive extract)
Arm Type
No Intervention
Arm Description
These are patients that are COVID19 negative at the start, live with a COVID19 positive patient and who elect to NOT try the extract.
Intervention Type
Other
Intervention Name(s)
Proprietary extract of Nerium oleander
Intervention Description
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.
Primary Outcome Measure Information:
Title
COVID19 symptoms
Description
The CDC list of symptoms and "other".
Time Frame
Every 6 hours for 10 days
Title
Mortality
Description
A patient in any arm that dies.
Time Frame
10 days from enrollment into the Study, e.g. Day 10
Secondary Outcome Measure Information:
Title
COVID19 Live Virus
Description
COVID19 Live Virus Nasopharyngeal swab performed by UTMB, Texas
Time Frame
Day 1, Day 5, Day 10
Title
RT-PCR COVID19 Test
Description
RT-PCR Nasopharyngeal swab performed by Fulgent, California
Time Frame
Day 1, Day 5, Day 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Dunn, MD, Ph.D.
Organizational Affiliation
KDunn and Associates, PA dba Healthquilt
Official's Role
Principal Investigator
Facility Information:
Facility Name
KDunn and Associates, PA, dba Healthquilt
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.theschullinstitute.org
Links:
URL
http://doi.org/10.1101/2020.07.15.203489
Description
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.
Learn more about this trial
Impact Nerium Oleander on Immune Function
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