Impact Nerium Oleander on Immune Function
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
- Covid19 Positive Patient
- Covid19 Close Contact
- Immune Function
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
Arm | Description | Assigned Intervention |
---|---|---|
Experimental COVID19 Positive: Intervention Group (Receive extract) |
These are patients that are COVID19 positive who elect to try the extract. |
|
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. |
|
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.