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

Completed
Covid19 Positive Patient
Covid19 Close Contact
Immune Function

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.

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

KDunn and Associates, PA, dba Healthquilt
Houston, Texas, United States

Kim Dunn, MD, Ph.D., Principal Investigator
KDunn and Associates, PA dba Healthquilt

NCT Number
Keywords
COVID19
Nerium oleander
Clinical symptoms
Mortality
Immune Function
MeSH Terms
COVID-19