Impact Nerium Oleander on Immune Function

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of a Proprietary Extract of Nerium Oleander on Immune Function as Evidenced by Clinical Symptoms and Mortality :A Feasibility Study

Conditions
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Covid19 Positive Patient, Covid19 Close Contact, Immune Function

Intervention / Treatment
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* Other: Proprietary extract of Nerium oleander


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVID19 Positive: Intervention Group (Receive extract)<br>These are patients that are COVID19 positive who elect to try the extract. | Other: Proprietary extract of Nerium oleander<br>* 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.<br>|
| No Intervention: COVID19 Positive: Comparison Group (Do NOT receive extract)<br>These are patients that are COVID19 positive who do NOT elect to try the extract | |
| Experimental: COVID19 Exposed: Intervention Group (Receive extract)<br>These are patients that are COVID19 negative at the start, live with a COVID19 positive patient and who elect to try the extract. | Other: Proprietary extract of Nerium oleander<br>* 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.<br>|
| No Intervention: COVID19 Exposed: Comparison Group (Do NOT receive extract)<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID19 symptoms | The CDC list of symptoms and other. | Every 6 hours for 10 days | 
| Mortality | 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 | COVID19 Live Virus Nasopharyngeal swab performed by UTMB, Texas | Day 1, Day 5, Day 10 | 
| RT-PCR COVID19 Test | RT-PCR Nasopharyngeal swab performed by Fulgent, California | Day 1, Day 5, Day 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immune Function, Covid19, Nerium oleander, Clinical symptoms, Mortality