Impact Nerium Oleander on Immune Function

HealthQuilt

Status: Completed

Conditions: Covid19 Positive Patient; Immune Function; Covid19 Close Contact

Treatments: Other: Proprietary extract of Nerium oleander

Study type: Interventional

Funder types: Other

Identifiers

NCT04486144

052020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 4 patient groups

COVID19 Positive: Intervention Group (Receive extract)

Experimental group

Description:

These are patients that are COVID19 positive who elect to try the extract.

Treatment:

Other: Proprietary extract of Nerium oleander

COVID19 Positive: Comparison Group (Do NOT receive extract)

No Intervention group

Description:

These are patients that are COVID19 positive who do NOT elect to try the extract

COVID19 Exposed: Intervention Group (Receive extract)

Experimental group

Description:

These are patients that are COVID19 negative at the start, live with a COVID19 positive patient and who elect to try the extract.

Treatment:

Other: Proprietary extract of Nerium oleander

COVID19 Exposed: Comparison Group (Do NOT receive extract)

No Intervention group

Description:

These are patients that are COVID19 negative at the start, live with a COVID19 positive patient and who elect to NOT try the extract.