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Trial record 1 of 2 for:    oleander
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Impact Nerium Oleander on Symptoms and Mortality: A Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04486144
Recruitment Status : Enrolling by invitation
First Posted : July 24, 2020
Last Update Posted : July 24, 2020
Sponsor:
Collaborators:
The Schull Institute
Texas A&M University
The Hildebrand Fund at the Greater Houston Community Foundation
Baylor College of Medicine
The University of Texas Health Science Center, Houston
University of Maryland, College Park
Information provided by (Responsible Party):
HealthQuilt

Tracking Information
First Submitted Date  ICMJE July 20, 2020
First Posted Date  ICMJE July 24, 2020
Last Update Posted Date July 24, 2020
Actual Study Start Date  ICMJE May 20, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2020)
  • COVID19 symptoms [ Time Frame: Every 6 hours for 10 days ]
    The CDC list of symptoms and "other".
  • Mortality [ Time Frame: 10 days from enrollment into the Study, e.g. Day 10 ]
    A patient in any arm that dies.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2020)
  • COVID19 Live Virus [ Time Frame: Day 1, Day 5, Day 10 ]
    COVID19 Live Virus Nasopharyngeal swab performed by UTMB, Texas
  • RT-PCR COVID19 Test [ Time Frame: Day 1, Day 5, Day 10 ]
    RT-PCR Nasopharyngeal swab performed by Fulgent, California
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact Nerium Oleander on Symptoms and Mortality: A Feasibility Study
Official Title  ICMJE Impact of a Proprietary Extract of Nerium Oleander on Symptoms and Mortality :A Feasibility Study
Brief Summary Assess the impact of a proprietary extract of Nerium oleander on 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 (animals and humans). 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Covid19 Positive Patient
  • Covid19 Close Contact
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: COVID19 Positive: Intervention Group (Receive extract)
    These are patients that are COVID19 positive who elect to try the extract.
    Intervention: Other: Proprietary extract of Nerium oleander
  • 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.
    Intervention: Other: Proprietary extract of Nerium oleander
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 22, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04486144
Other Study ID Numbers  ICMJE 052020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: KDunn and Associates, PA will de-identify data and archive it at The Schull Institute Data Archive at the University of Texas School of Biomedical Informatics.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: October 2020
Access Criteria: Need to have a specific question or plan to study further.
URL: http://www.theschullinstitute.org
Responsible Party HealthQuilt
Study Sponsor  ICMJE HealthQuilt
Collaborators  ICMJE
  • The Schull Institute
  • Texas A&M University
  • The Hildebrand Fund at the Greater Houston Community Foundation
  • Baylor College of Medicine
  • The University of Texas Health Science Center, Houston
  • University of Maryland, College Park
Investigators  ICMJE
Principal Investigator: Kim Dunn, MD, Ph.D. KDunn and Associates, PA dba Healthquilt
PRS Account HealthQuilt
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP