NCT04486144

Impact Nerium Oleander on Immune Function

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: HealthQuilt · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19 Positive Patient
• Covid19 Close Contact
• Immune Function

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-05-20
• Primary completion: 2020-07-23
• Completion: 2020-07-23
• First posted: 2020-07-24
• Last updated: 2021-04-22

Locations

1 site across 1 country: United States