Impact Nerium Oleander on Immune Function

HealthQuilt82 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Covid19 Positive Patient Covid19 Close Contact Immune Function

Interventions

Proprietary extract of Nerium oleanderOTHER

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

KDunn and Associates, PA, dba Healthquilt

Houston, Texas, United States

Outcomes

Primary Outcomes

COVID19 symptoms

The CDC list of symptoms and "other".

Time frame: Every 6 hours for 10 days

Mortality

A patient in any arm that dies.

Time frame: 10 days from enrollment into the Study, e.g. Day 10

Secondary Outcomes

COVID19 Live Virus

COVID19 Live Virus Nasopharyngeal swab performed by UTMB, Texas

Time frame: Day 1, Day 5, Day 10

RT-PCR COVID19 Test

RT-PCR Nasopharyngeal swab performed by Fulgent, California

Time frame: Day 1, Day 5, Day 10

Data from ClinicalTrials.gov

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