Impact Nerium Oleander on Immune Function

NCT ID: NCT04486144

Last Updated: 2021-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-20
• Study Completion Date: 2020-07-23

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.

Conditions

Covid19 Positive Patient; Covid19 Close Contact; Immune Function

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

COVID19 Positive: Intervention Group (Receive extract)

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

Group Type: EXPERIMENTAL

Proprietary extract of Nerium oleander

Intervention Type: OTHER

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.

COVID19 Positive: Comparison Group (Do NOT receive extract)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Proprietary extract of Nerium oleander

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HealthQuilt

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kim Dunn, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

KDunn and Associates, PA dba Healthquilt

Locations

KDunn and Associates, PA, dba Healthquilt

Houston, Texas, United States

Countries

United States

Other Identifiers

052020

Identifier Type: -

Identifier Source: org_study_id