Covid19 Close Contact, Covid19 Positive Patient, Immune Function
Conditions
Keywords
Covid19, Nerium oleander, Clinical symptoms, Mortality, Immune Function
Brief 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.
Interventions
OTHERProprietary 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.
Sponsors
HealthQuilt
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COVID19 symptoms | Every 6 hours for 10 days | The CDC list of symptoms and other. |
| Mortality | 10 days from enrollment into the Study, e.g. Day 10 | A patient in any arm that dies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COVID19 Live Virus | Day 1, Day 5, Day 10 | COVID19 Live Virus Nasopharyngeal swab performed by UTMB, Texas |
| RT-PCR COVID19 Test | Day 1, Day 5, Day 10 | RT-PCR Nasopharyngeal swab performed by Fulgent, California |
Countries
United States
Outcome results
None listed