<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04486144</url>
  </required_header>
  <id_info>
    <org_study_id>052020</org_study_id>
    <nct_id>NCT04486144</nct_id>
  </id_info>
  <brief_title>Impact Nerium Oleander on Immune Function</brief_title>
  <official_title>Impact of a Proprietary Extract of Nerium Oleander on Immune Function as Evidenced by Clinical Symptoms and Mortality :A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HealthQuilt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HealthQuilt</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assess the impact of a proprietary extract of Nerium oleander on immune function as evidenced&#xD;
      by COVID-19 symptoms and mortality in COVID-19 positive patients and their close contacts&#xD;
      compared to controls that did not receive the extract.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an exploratory study based on positive in-vitro, and in-vivo (humans) that appear to&#xD;
      support an immune function benefit. Up to 100 patients that are COVID-19 positive in the&#xD;
      ambulatory setting will be invited to participate. After informed consent is obtained,&#xD;
      patients will be in either the Intervention Group (receive extract) or Comparison Group (did&#xD;
      not receive extract). A baseline assessment and record review will be conducted to assure&#xD;
      eligibility criteria. Patients in the Intervention Group will be given .5 ml (6.25 mg of&#xD;
      extract) every 6 hours for 5 days, total of 25 mg per day / 125 mg for 5 days. Patient vital&#xD;
      signs (temperature, pulse oximetry, blood pressure) and CDC symptoms / side effects will also&#xD;
      be tracked. A dedicated medical oversight team with 24 / 7 access to care will be provided to&#xD;
      monitor safety and tolerance. Patients will be followed for 10 days. Baseline antibody,&#xD;
      RT-PCR, and live virus will be collected on Day 1, Day 5, and Day 10. A Data Monitoring&#xD;
      Committee at the Schull Institute will meet weekly to review data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Actual">July 23, 2020</completion_date>
  <primary_completion_date type="Actual">July 23, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>COVID19 symptoms</measure>
    <time_frame>Every 6 hours for 10 days</time_frame>
    <description>The CDC list of symptoms and &quot;other&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>10 days from enrollment into the Study, e.g. Day 10</time_frame>
    <description>A patient in any arm that dies.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>COVID19 Live Virus</measure>
    <time_frame>Day 1, Day 5, Day 10</time_frame>
    <description>COVID19 Live Virus Nasopharyngeal swab performed by UTMB, Texas</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RT-PCR COVID19 Test</measure>
    <time_frame>Day 1, Day 5, Day 10</time_frame>
    <description>RT-PCR Nasopharyngeal swab performed by Fulgent, California</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Covid19 Positive Patient</condition>
  <condition>Covid19 Close Contact</condition>
  <condition>Immune Function</condition>
  <arm_group>
    <arm_group_label>COVID19 Positive: Intervention Group (Receive extract)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>These are patients that are COVID19 positive who elect to try the extract.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COVID19 Positive: Comparison Group (Do NOT receive extract)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>These are patients that are COVID19 positive who do NOT elect to try the extract</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COVID19 Exposed: Intervention Group (Receive extract)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>These are patients that are COVID19 negative at the start, live with a COVID19 positive patient and who elect to try the extract.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COVID19 Exposed: Comparison Group (Do NOT receive extract)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Proprietary extract of Nerium oleander</intervention_name>
    <description>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.</description>
    <arm_group_label>COVID19 Exposed: Intervention Group (Receive extract)</arm_group_label>
    <arm_group_label>COVID19 Positive: Intervention Group (Receive extract)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18&#xD;
&#xD;
          -  COVID 19 positive or close contact of COVID 19 positive&#xD;
&#xD;
          -  No use of cardiac glycosides or other antiarrhythmic medications&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No use of cardiac glycosides or other antiarrhythmic medications&#xD;
&#xD;
          -  No allergy to coconut oil&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kim Dunn, MD, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>KDunn and Associates, PA dba Healthquilt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KDunn and Associates, PA, dba Healthquilt</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://doi.org/10.1101/2020.07.15.203489</url>
    <description>Plante KS, Plante JA, Fernandez D, et al. Prophylactic and therapeutic inhibition of in vitro SARS-CoV-2 replication by Oleandrin. bioRxiv. July 15, 2020. Cold Spring Harbor Laboratory.</description>
  </link>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>April 20, 2021</last_update_submitted>
  <last_update_submitted_qc>April 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Covid19</keyword>
  <keyword>Nerium oleander</keyword>
  <keyword>Clinical symptoms</keyword>
  <keyword>Mortality</keyword>
  <keyword>Immune Function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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 after the Summer Research Program Conclusion.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>October 2020</ipd_time_frame>
    <ipd_access_criteria>Need to have a specific question or plan to study further.</ipd_access_criteria>
    <ipd_url>http://www.theschullinstitute.org</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04486144
org study id: 052020
nct id: NCT04486144
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: COVID19 symptoms
time frame: Every 6 hours for 10 days
description: The CDC list of symptoms and "other".
measure: Mortality
time frame: 10 days from enrollment into the Study, e.g. Day 10
description: A patient in any arm that dies.
measure: COVID19 Live Virus
time frame: Day 1, Day 5, Day 10
description: COVID19 Live Virus Nasopharyngeal swab performed by UTMB, Texas
measure: RT-PCR COVID19 Test
time frame: Day 1, Day 5, Day 10
description: RT-PCR Nasopharyngeal swab performed by Fulgent, California
arm group label: COVID19 Positive: Intervention Group (Receive extract)
arm group type: Experimental
description: These are patients that are COVID19 positive who elect to try the extract.
arm group label: COVID19 Positive: Comparison Group (Do NOT receive extract)
arm group type: No Intervention
description: These are patients that are COVID19 positive who do NOT elect to try the extract
arm group label: COVID19 Exposed: Intervention Group (Receive extract)
arm group type: Experimental
description: These are patients that are COVID19 negative at the start, live with a COVID19 positive patient and who elect to try the extract.
arm group label: COVID19 Exposed: Comparison Group (Do NOT receive extract)
arm group type: No Intervention
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.
intervention type: Other
intervention name: Proprietary extract of Nerium oleander
description: 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.
arm group label: COVID19 Exposed: Intervention Group (Receive extract)
arm group label: COVID19 Positive: Intervention Group (Receive extract)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kim Dunn, MD, Ph.D.
role: Principal Investigator
affiliation: KDunn and Associates, PA dba Healthquilt
facility: 
country: United States
url: http://doi.org/10.1101/2020.07.15.203489
description: Plante KS, Plante JA, Fernandez D, et al. Prophylactic and therapeutic inhibition of in vitro SARS-CoV-2 replication by Oleandrin. bioRxiv. July 15, 2020. Cold Spring Harbor Laboratory.
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Yes
ipd 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 after the Summer Research Program Conclusion.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: October 2020
ipd access criteria: Need to have a specific question or plan to study further.
ipd url: http://www.theschullinstitute.org