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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
COVID19 Positive: Intervention Group (Receive extract) 		These are patients that are COVID19 positive who elect to try the extract.
  • 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.
No Intervention
COVID19 Positive: Comparison Group (Do NOT receive extract) 		These are patients that are COVID19 positive who do NOT elect to try the extract
Experimental
COVID19 Exposed: Intervention Group (Receive extract) 		These are patients that are COVID19 negative at the start, live with a COVID19 positive patient and who elect to try the extract.
  • 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.
No Intervention
COVID19 Exposed: Comparison Group (Do NOT receive extract) 		These are patients that are COVID19 negative at the start, live with a COVID19 positive patient and who elect to NOT try the extract.

Recruiting Locations

More Details

NCT ID
NCT04486144
Status
Completed
Sponsor
HealthQuilt

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.