Impact Nerium Oleander on Immune Function

Immune Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04486144
• Other study ID #: 052020
• Status: Completed
• Phase: N/A
• Start date: May 20, 2020
• Est. completion date: July 23, 2020

Study information

• Verified date: April 2021
• Source: HealthQuilt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: July 23, 2020
• Est. primary completion date: July 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19 Close Contact
• Covid19 Positive Patient
• Immune Function

Intervention

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.

Locations

Country	Name	City	State
United States	KDunn and Associates, PA, dba Healthquilt	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
HealthQuilt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID19 symptoms	The CDC list of symptoms and "other".	Every 6 hours for 10 days
Primary	Mortality	A patient in any arm that dies.	10 days from enrollment into the Study, e.g. Day 10
Secondary	COVID19 Live Virus	COVID19 Live Virus Nasopharyngeal swab performed by UTMB, Texas	Day 1, Day 5, Day 10
Secondary	RT-PCR COVID19 Test	RT-PCR Nasopharyngeal swab performed by Fulgent, California	Day 1, Day 5, Day 10

External Links

•   Plante KS, Plante JA, Fernandez D, et al. Prophylactic and therapeutic inhibition of in vitro SARS-CoV-2 replication by Oleandrin. bioRxiv. July 15, 2020. Cold Spring Harbor Laboratory.