Impact Nerium Oleander on Immune Function
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04486144 |
Recruitment Status :
Completed
First Posted : July 24, 2020
Last Update Posted : April 22, 2021
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Condition or disease | Intervention/treatment | Phase |
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Covid19 Positive Patient Covid19 Close Contact Immune Function | Other: Proprietary extract of Nerium oleander | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 82 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Impact of a Proprietary Extract of Nerium Oleander on Immune Function as Evidenced by Clinical Symptoms and Mortality :A Feasibility Study |
Actual Study Start Date : | May 20, 2020 |
Actual Primary Completion Date : | July 23, 2020 |
Actual Study Completion Date : | July 23, 2020 |

Arm | Intervention/treatment |
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Experimental: COVID19 Positive: Intervention Group (Receive extract)
These are patients that are COVID19 positive who elect to try the extract.
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Other: Proprietary extract of Nerium oleander
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
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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.
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Other: Proprietary extract of Nerium oleander
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.
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- 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.
- COVID19 Live Virus [ Time Frame: Day 1, Day 5, Day 10 ]COVID19 Live Virus Nasopharyngeal swab performed by UTMB, Texas
- RT-PCR COVID19 Test [ Time Frame: Day 1, Day 5, Day 10 ]RT-PCR Nasopharyngeal swab performed by Fulgent, California

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04486144
United States, Texas | |
KDunn and Associates, PA, dba Healthquilt | |
Houston, Texas, United States, 77055 |
Principal Investigator: | Kim Dunn, MD, Ph.D. | KDunn and Associates, PA dba Healthquilt |
Responsible Party: | HealthQuilt |
ClinicalTrials.gov Identifier: | NCT04486144 |
Other Study ID Numbers: |
052020 |
First Posted: | July 24, 2020 Key Record Dates |
Last Update Posted: | April 22, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | October 2020 |
Access Criteria: | Need to have a specific question or plan to study further. |
URL: | http://www.theschullinstitute.org |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Covid19 Nerium oleander Clinical symptoms Mortality Immune Function |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |