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OpenTrials
Completed

NCT Number: NCT04486144

Impact Nerium Oleander on Immune Function

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.

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Key information

Conditions

Covid19 Positive Patient COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Close Contact Immune Function Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KDunn and Associates, PA, dba Healthquilt

Houston, Texas, 77055, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proprietary extract of Nerium oleander

Other

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 outcomes

  1. COVID19 symptoms

    Time frame: Every 6 hours for 10 days

    The CDC list of symptoms and "other".

  2. Mortality

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

    A patient in any arm that dies.

Secondary outcomes

  1. COVID19 Live Virus

    Time frame: Day 1, Day 5, Day 10

    COVID19 Live Virus Nasopharyngeal swab performed by UTMB, Texas

  2. RT-PCR COVID19 Test

    Time frame: Day 1, Day 5, Day 10

    RT-PCR Nasopharyngeal swab performed by Fulgent, California

Sponsors and collaborators

Lead sponsor

HealthQuilt

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 24, 2020
Registry last updated
Apr 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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