<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/NCT04400890</url>
  </required_header>
  <id_info>
    <org_study_id>McCreary2020</org_study_id>
    <nct_id>NCT04400890</nct_id>
  </id_info>
  <brief_title>Randomized Proof-of-Concept Trial to Evaluate the Safety and Explore the Effectiveness of Resveratrol, a Plant Polyphenol, for COVID-19</brief_title>
  <official_title>Randomized Double-Blind Placebo-Controlled Proof-of-Concept Trial of Resveratrol, a Plant Polyphenol, for the Outpatient Treatment of Mild Coronavirus Disease (COVID-19)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marvin McCreary, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mount Carmel Health System</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Resveratrol is a plant polyphenol (that is sold commercially as a supplement) that might help&#xD;
      fight coronavirus as well as help protect the body from the effects of disease (COVID-19)&#xD;
      caused by the infection. In this proof-of-concept pilot study we will compare the effects of&#xD;
      resveratrol to placebo to assess the safety of the resveratrol and explore effectiveness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized placebo-controlled trial is for the outpatient treatment of (Coronavirus&#xD;
      Disease 2019) COVID-19. The purpose of this trial is to evaluate the safety and explore the&#xD;
      effectiveness of resveratrol, a plant polyphenol, being re-purposed for patients with early&#xD;
      COVID-19. Published in vitro data supports that this polyphenol inhibits coronavirus&#xD;
      replication while separately published in silico (computer molecular docking analysis)&#xD;
      reports have identified specific molecular targets of resveratrol against (Severe Acute&#xD;
      Respiratory Syndrome - Coronavirus 2) SARS-CoV-2. Animal studies also demonstrate that&#xD;
      resveratrol is effective at preventing lung injury and death in certain animal models of&#xD;
      viral infections. Furthermore, the products long history as an anti-inflammatory might&#xD;
      prevent the cytokine storm that is associated with worse outcomes in COVID-19.&#xD;
&#xD;
      200 subjects, 45 and older, (100 receiving the plant polyphenol, 100 receiving placebo) will&#xD;
      be enrolled in study to compare whether taking resveratrol will reduce the rate of&#xD;
      hospitalization. Subjects will take capsules 4 times a day for a minimum of 7 days (up to 15&#xD;
      days depending on duration of symptoms) plus both groups will receive Vitamin D3 100,000 IU&#xD;
      to augment the effects of resveratrol. Resveratrol will be given as 1gm 4 times per day.&#xD;
      Placebo tablets will contain brown rice flour in visually identical capsules. The primary&#xD;
      outcome measure for this trial is reduction in hospitalization at 21 days from enrollment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Feasibility&#xD;
  </why_stopped>
  <start_date type="Actual">September 13, 2020</start_date>
  <completion_date type="Actual">March 1, 2021</completion_date>
  <primary_completion_date type="Actual">March 1, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hospitalization Rates for COVID-19</measure>
    <time_frame>21 days from study randomization</time_frame>
    <description>Number of study participants admitted to the hospital within 21 days of randomization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU Admission Rates</measure>
    <time_frame>21 days from randomization</time_frame>
    <description>Number of study participants admitted within 21 who subsequently get admitted to the ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Invasive Ventilation Rates</measure>
    <time_frame>21 days from randomization</time_frame>
    <description>Number of study participants who get admitted with 21 day of randomization who receiving invasive ventilation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pneumonia</measure>
    <time_frame>21 days from randomization</time_frame>
    <description>Number of study participants are diagnosed with pneumonia with 21 day of randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary Embolism</measure>
    <time_frame>21 days from start of randomization.</time_frame>
    <description>Number of study participants are diagnosed with pulmonary embolism with 21 day of randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>Within 21 days from randomization</time_frame>
    <description>Number of study participants who died with 21 day of randomization</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse Events</measure>
    <time_frame>60 days from randomization</time_frame>
    <description>Diarrhea, nausea, abdominal cramping</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Resveratrol with Vitamin D3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Resveratrol 1000mg four times per day for 15 days. Vitamin D3 100,000 IU on day 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo with Vitamin D3</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsules 4 times per day for 15 days. Vitamin D3 100,000 IU on day 1</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Resveratrol</intervention_name>
    <description>Resveratrol vs placebo given for 15 days.</description>
    <arm_group_label>Resveratrol with Vitamin D3</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D3</intervention_name>
    <description>Vitamin D3 100,000 IU given on day one.</description>
    <arm_group_label>Placebo with Vitamin D3</arm_group_label>
    <arm_group_label>Resveratrol with Vitamin D3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Outpatients who test positive for infection with SARS-CoV-2.&#xD;
&#xD;
          -  Age ≥45 years&#xD;
&#xD;
          -  Mild COVID-19 based on World Health Organization (WHO) Baseline Severity&#xD;
             Categorization&#xD;
&#xD;
          -  Symptom duration ≤ 10 days, or &lt;72 hours of new respiratory symptoms.&#xD;
&#xD;
          -  Patient must have access to the internet or a smartphone to complete surveys.&#xD;
&#xD;
          -  English-speaking patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed or suspected cognitive impairment that would prevent the patient from&#xD;
             cooperating with study procedures, as judged by the screening clinician&#xD;
&#xD;
          -  Asymptomatic patients (e.g. patients who were screened without symptoms but tested&#xD;
             positive)&#xD;
&#xD;
          -  Known or suspected liver disease or Hepatitis C&#xD;
&#xD;
          -  Known kidney disease with estimate Glomerular Filtration Rate (eGFR) &lt;60&#xD;
&#xD;
          -  Patients on warfarin, Novel Oral Anticoagulants (NOACs), HIV Protease Inhibitors,&#xD;
             immunosuppressants, hydroxychloroquine/chloroquine, and other medication with a narrow&#xD;
             therapeutic window.&#xD;
&#xD;
          -  Allergy to grapes or rice.&#xD;
&#xD;
          -  Co-morbidities with a high likelihood of hospitalization within 30 days (e.g., current&#xD;
             cancer treatment, severe Chronic Obstructive Pulmonary Disease (COPD) or Congestive&#xD;
             Heart Failure (CHF))&#xD;
&#xD;
          -  Currently pregnant&#xD;
&#xD;
          -  Hospitalization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marvin R McCreary</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mount Carmel Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mt Carmel HealthSystems</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.nature.com/articles/s41598-022-13920-9</url>
    <description>Peer reviewed final publication</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <results_first_submitted>June 30, 2022</results_first_submitted>
  <results_first_submitted_qc>February 22, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 24, 2023</results_first_posted>
  <last_update_submitted>February 22, 2023</last_update_submitted>
  <last_update_submitted_qc>February 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mount Carmel Health System</investigator_affiliation>
    <investigator_full_name>Marvin McCreary, MD</investigator_full_name>
    <investigator_title>Emergency Physician</investigator_title>
  </responsible_party>
  <keyword>Coronavirus</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>COVID</keyword>
  <keyword>Vitamin D3</keyword>
  <keyword>Cholecalciferol</keyword>
  <keyword>Supplement</keyword>
  <keyword>Polyphenol</keyword>
  <keyword>Resveratrol</keyword>
  <keyword>Stilbene</keyword>
  <keyword>phytoalexin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Resveratrol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan: Study Protocol with SAP</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT04400890/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Between September 13, 2020 and December 11, 2020, 1,694 patients were telephoned within 24-h of testing positive for COVID-19 to be recruited into the clinical trial . One-hundred-five were enrolled and randomized. Five withdrew after receiving treatment packets (four withdrew before starting treatment and one withdrew after one treatment day citing &quot;too many pills&quot; as reason for withdrawal).</recruitment_details>
      <pre_assignment_details>One-hundred-five subjects were enrolled and randomized. Four participants withdrew before starting treatment. One participant withdrew after one treatment day citing &quot;too many pills&quot; as reason for withdrawal.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Resveratrol With Vitamin D3</title>
          <description>Resveratrol 1000mg four times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1&#xD;
Vitamin D3: Vitamin D3 100,000 IU given on day one.</description>
        </group>
        <group group_id="P2">
          <title>Placebo With Vitamin D3</title>
          <description>Placebo capsules 4 times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1&#xD;
Vitamin D3: Vitamin D3 100,000 IU given on day one.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated Per Protocol Population</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Between September 13, 2020 and December 11, 2020, 1,694 patients were telephoned within 24-h of testing positive for COVID-19 to be recruited into the clinical trial . One-hundred-five were enrolled and randomized. Five withdrew after receiving treatment packets (four withdrew before starting treatment and one withdrew after one treatment day citing &quot;too many pills&quot; as reason for withdrawal).</population>
      <group_list>
        <group group_id="B1">
          <title>Resveratrol With Vitamin D3</title>
          <description>Resveratrol 1000mg four times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1&#xD;
Vitamin D3: Vitamin D3 100,000 IU given on day one.</description>
        </group>
        <group group_id="B2">
          <title>Placebo With Vitamin D3</title>
          <description>Placebo capsules 4 times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1&#xD;
Vitamin D3: Vitamin D3 100,000 IU given on day one.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="53"/>
            <count group_id="B2" value="52"/>
            <count group_id="B3" value="105"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.7" spread="8.55"/>
                    <measurement group_id="B2" value="56.3" spread="9.46"/>
                    <measurement group_id="B3" value="56.0" spread="8.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="93"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.1" spread="4.68"/>
                    <measurement group_id="B2" value="31.4" spread="7.32"/>
                    <measurement group_id="B3" value="30.2" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>High Risk Comorbidity= YES</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>High Risk Comorbidity= NO</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Chronic Lung Disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes Mellitus</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cardiovascular Disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Renal Disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Liver Disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Immunocompromised</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Current Smoker</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Former Smoker</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Angiotensin Converting Enzyme Inhibitor (ACEI) / Angiotensin Receptor Blocker (ARB) use</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Vitamin D use</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Oral Steroid Use</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Inhaled Steroid Use</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Hospitalization Rates for COVID-19</title>
        <description>Number of study participants admitted to the hospital within 21 days of randomization</description>
        <time_frame>21 days from study randomization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Resveratrol With Vitamin D3</title>
            <description>Resveratrol 1000mg four times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1&#xD;
Vitamin D3: Vitamin D3 100,000 IU given on day one.</description>
          </group>
          <group group_id="O2">
            <title>Placebo With Vitamin D3</title>
            <description>Placebo capsules 4 times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1&#xD;
Vitamin D3: Vitamin D3 100,000 IU given on day one.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospitalization Rates for COVID-19</title>
          <description>Number of study participants admitted to the hospital within 21 days of randomization</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ICU Admission Rates</title>
        <description>Number of study participants admitted within 21 who subsequently get admitted to the ICU</description>
        <time_frame>21 days from randomization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Resveratrol With Vitamin D3</title>
            <description>Resveratrol 1000mg four times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1&#xD;
Vitamin D3: Vitamin D3 100,000 IU given on day one.</description>
          </group>
          <group group_id="O2">
            <title>Placebo With Vitamin D3</title>
            <description>Placebo capsules 4 times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1&#xD;
Vitamin D3: Vitamin D3 100,000 IU given on day one.</description>
          </group>
        </group_list>
        <measure>
          <title>ICU Admission Rates</title>
          <description>Number of study participants admitted within 21 who subsequently get admitted to the ICU</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Invasive Ventilation Rates</title>
        <description>Number of study participants who get admitted with 21 day of randomization who receiving invasive ventilation.</description>
        <time_frame>21 days from randomization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Resveratrol With Vitamin D3</title>
            <description>Resveratrol 1000mg four times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1&#xD;
Vitamin D3: Vitamin D3 100,000 IU given on day one.</description>
          </group>
          <group group_id="O2">
            <title>Placebo With Vitamin D3</title>
            <description>Placebo capsules 4 times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1&#xD;
Vitamin D3: Vitamin D3 100,000 IU given on day one.</description>
          </group>
        </group_list>
        <measure>
          <title>Invasive Ventilation Rates</title>
          <description>Number of study participants who get admitted with 21 day of randomization who receiving invasive ventilation.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pneumonia</title>
        <description>Number of study participants are diagnosed with pneumonia with 21 day of randomization</description>
        <time_frame>21 days from randomization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Resveratrol With Vitamin D3</title>
            <description>Resveratrol 1000mg four times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1&#xD;
Vitamin D3: Vitamin D3 100,000 IU given on day one.</description>
          </group>
          <group group_id="O2">
            <title>Placebo With Vitamin D3</title>
            <description>Placebo capsules 4 times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1&#xD;
Vitamin D3: Vitamin D3 100,000 IU given on day one.</description>
          </group>
        </group_list>
        <measure>
          <title>Pneumonia</title>
          <description>Number of study participants are diagnosed with pneumonia with 21 day of randomization</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pulmonary Embolism</title>
        <description>Number of study participants are diagnosed with pulmonary embolism with 21 day of randomization</description>
        <time_frame>21 days from start of randomization.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Resveratrol With Vitamin D3</title>
            <description>Resveratrol 1000mg four times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1&#xD;
Vitamin D3: Vitamin D3 100,000 IU given on day one.</description>
          </group>
          <group group_id="O2">
            <title>Placebo With Vitamin D3</title>
            <description>Placebo capsules 4 times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1&#xD;
Vitamin D3: Vitamin D3 100,000 IU given on day one.</description>
          </group>
        </group_list>
        <measure>
          <title>Pulmonary Embolism</title>
          <description>Number of study participants are diagnosed with pulmonary embolism with 21 day of randomization</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Death</title>
        <description>Number of study participants who died with 21 day of randomization</description>
        <time_frame>Within 21 days from randomization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Resveratrol With Vitamin D3</title>
            <description>Resveratrol 1000mg four times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1&#xD;
Vitamin D3: Vitamin D3 100,000 IU given on day one.</description>
          </group>
          <group group_id="O2">
            <title>Placebo With Vitamin D3</title>
            <description>Placebo capsules 4 times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1&#xD;
Vitamin D3: Vitamin D3 100,000 IU given on day one.</description>
          </group>
        </group_list>
        <measure>
          <title>Death</title>
          <description>Number of study participants who died with 21 day of randomization</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Adverse Events</title>
        <description>Diarrhea, nausea, abdominal cramping</description>
        <time_frame>60 days from randomization</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>With 60 days of randomization</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Resveratrol With Vitamin D3</title>
          <description>Resveratrol 1000mg four times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1&#xD;
Vitamin D3: Vitamin D3 100,000 IU given on day one.</description>
        </group>
        <group group_id="E2">
          <title>Placebo With Vitamin D3</title>
          <description>Placebo capsules 4 times per day for up to 15 days (7 days minimum). Vitamin D3 100,000 IU on day 1&#xD;
Vitamin D3: Vitamin D3 100,000 IU given on day one.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>PRO-CTCAE</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>PRO-CTCAE</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="50" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Nosebleeds</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Racing Heartbeat</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blurry Vision</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Redness or watery eyes</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Increased Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Sore Throat / Mount</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Problems Tasting / Smelling</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Decreased Appetitis</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Heartburn</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pain in Abdomen</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Shivering</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Aching Muscle</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Aching Joint</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Problems Concentrating</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Problems with memory</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hoarse Voice</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hives</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Bruises easily</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Itchy Skin</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The actual rate of primary and secondary COVID-19 outcome measures were lower than expected. Therefore the study plan had inadequate number of participants and was therefore under-powered.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Marvin McCreary, MD</name_or_title>
      <organization>formerly of Mount Carmel Health Systems</organization>
      <phone>614-526-8492</phone>
      <email>Marvin.McCreary+RCT@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04400890
org study id: McCreary2020
nct id: NCT04400890
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Resveratrol is a plant polyphenol (that is sold commercially as a supplement) that might help
      fight coronavirus as well as help protect the body from the effects of disease (COVID-19)
      caused by the infection. In this proof-of-concept pilot study we will compare the effects of
      resveratrol to placebo to assess the safety of the resveratrol and explore effectiveness.
This randomized placebo-controlled trial is for the outpatient treatment of (Coronavirus
      Disease 2019) COVID-19. The purpose of this trial is to evaluate the safety and explore the
      effectiveness of resveratrol, a plant polyphenol, being re-purposed for patients with early
      COVID-19. Published in vitro data supports that this polyphenol inhibits coronavirus
      replication while separately published in silico (computer molecular docking analysis)
      reports have identified specific molecular targets of resveratrol against (Severe Acute
      Respiratory Syndrome - Coronavirus 2) SARS-CoV-2. Animal studies also demonstrate that
      resveratrol is effective at preventing lung injury and death in certain animal models of
      viral infections. Furthermore, the products long history as an anti-inflammatory might
      prevent the cytokine storm that is associated with worse outcomes in COVID-19.

      200 subjects, 45 and older, (100 receiving the plant polyphenol, 100 receiving placebo) will
      be enrolled in study to compare whether taking resveratrol will reduce the rate of
      hospitalization. Subjects will take capsules 4 times a day for a minimum of 7 days (up to 15
      days depending on duration of symptoms) plus both groups will receive Vitamin D3 100,000 IU
      to augment the effects of resveratrol. Resveratrol will be given as 1gm 4 times per day.
      Placebo tablets will contain brown rice flour in visually identical capsules. The primary
      outcome measure for this trial is reduction in hospitalization at 21 days from enrollment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Hospitalization Rates for COVID-19
time frame: 21 days from study randomization
description: Number of study participants admitted to the hospital within 21 days of randomization
measure: ICU Admission Rates
time frame: 21 days from randomization
description: Number of study participants admitted within 21 who subsequently get admitted to the ICU
measure: Invasive Ventilation Rates
time frame: 21 days from randomization
description: Number of study participants who get admitted with 21 day of randomization who receiving invasive ventilation.
measure: Pneumonia
time frame: 21 days from randomization
description: Number of study participants are diagnosed with pneumonia with 21 day of randomization
measure: Pulmonary Embolism
time frame: 21 days from start of randomization.
description: Number of study participants are diagnosed with pulmonary embolism with 21 day of randomization
measure: Death
time frame: Within 21 days from randomization
description: Number of study participants who died with 21 day of randomization
measure: Adverse Events
time frame: 60 days from randomization
description: Diarrhea, nausea, abdominal cramping
arm group label: Resveratrol with Vitamin D3
arm group type: Active Comparator
description: Resveratrol 1000mg four times per day for 15 days. Vitamin D3 100,000 IU on day 1
arm group label: Placebo with Vitamin D3
arm group type: Placebo Comparator
description: Placebo capsules 4 times per day for 15 days. Vitamin D3 100,000 IU on day 1
intervention type: Drug
intervention name: Resveratrol
description: Resveratrol vs placebo given for 15 days.
arm group label: Resveratrol with Vitamin D3
other name: Placebo
intervention type: Dietary Supplement
intervention name: Vitamin D3
description: Vitamin D3 100,000 IU given on day one.
arm group label: Placebo with Vitamin D3
arm group label: Resveratrol with Vitamin D3
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Marvin R McCreary
role: Principal Investigator
affiliation: Mount Carmel Health System
facility: 
country: United States
url: https://www.nature.com/articles/s41598-022-13920-9
description: Peer reviewed final publication
responsible party type: Sponsor-Investigator
investigator affiliation: Mount Carmel Health System
investigator full name: Marvin McCreary, MD
investigator title: Emergency Physician
mesh term: COVID-19
mesh term: Vitamin D
mesh term: Cholecalciferol
mesh term: Resveratrol
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The actual rate of primary and secondary COVID-19 outcome measures were lower than expected. Therefore the study plan had inadequate number of participants and was therefore under-powered.
point of contact: 