<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/NCT04489628</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY20200461</org_study_id>
    <nct_id>NCT04489628</nct_id>
  </id_info>
  <brief_title>Tele-health Enabled Clinical Trial for COVID-19</brief_title>
  <official_title>Tele-health Enabled Clinical Trial for COVID-19: Vitamin D as an Immunomodulator to Prevent Complications and Reduce Resource Utilization in Outpatients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospitals Cleveland Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospitals Cleveland Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the efficacy of high dose Vitamin D (an over-the-counter nutritional supplement)&#xD;
      in preventing immune-related complications in outpatients with confirmed SARS-CoV-2&#xD;
      infection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Unable to overcome hurdles to study recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">June 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 1, 2021</primary_completion_date>
  <phase>Phase 1/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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patients requiring admission to the hospital or experiencing death</measure>
    <time_frame>Days 1 to 15</time_frame>
    <description>Proportion of patients requiring admission to the hospital or experiencing death by Day 15</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>SARS-CoV Infection</condition>
  <arm_group>
    <arm_group_label>Vitamin D</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be given 8 capsules of either cholecalciferol 50,000 IU or placebo at study randomization. Participants will be instructed to take 4 capsules on receipt of the treatment package(Day 0), 2 capsules on Day 5, 1 capsule on Day 10, and 1 capsule on Day 15. A phone or text reminder will be included at Days 5, 10, and 15 to take the additional doses of vitamin D.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be given 8 capsules of either cholecalciferol 50,000 IU or placebo at study randomization. Participants will be instructed to take 4 capsules on receipt of the treatment package(Day 0), 2 capsules on Day 5, 1 capsule on Day 10, and 1 capsule on Day 15. A phone or text reminder will be included at Days 5, 10, and 15 to take the additional doses of vitamin D.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D3 or Placebo</intervention_name>
    <description>): Participants will be given 8 capsules of either cholecalciferol 50,000 IU or placebo at study randomization. Participants will be instructed to take 4 capsules on receipt of the treatment package(Day 0), 2 capsules on Day 5, 1 capsule on Day 10, and 1 capsule on Day 15. A phone or text reminder will be included at Days 5, 10, and 15 to take the additional doses of vitamin D.</description>
    <arm_group_label>Vitamin D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Doctella telehealth monitoring</intervention_name>
    <description>Doctella device will be give to participants by the Emergency department as part of usual care to monitor heart rate, respiratory rate, oxygen saturation, and perfusion index vitals continuously for approximately 10 days. The study team will receive the vitals signs data (heart rate, respiratory rate, oxygen saturation, perfusion index, and temperature) retrospectively and will not be able to monitor patients in real time.</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Vitamin D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥ 18 years of age&#xD;
&#xD;
          2. Laboratory confirmed SARS-CoV-2 infection &lt; 4 days before randomization&#xD;
&#xD;
          3. Report of symptoms consistent with SARS-CoV-2 infection (including but not limited to&#xD;
             fever, cough, muscle aches, joint pain, change in taste, change in smell, or shortness&#xD;
             of breath) &lt;4 days before admission&#xD;
&#xD;
          4. Asymptomatic or mild symptoms (not requiring hospital admission)&#xD;
&#xD;
          5. Access to and ability to use a mobile phone with telehealth capability&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unable to provide informed consent or comply with study directions&#xD;
&#xD;
          2. Admitted to an acute care bed&#xD;
&#xD;
          3. Baseline serum calcium &lt; 8.8 mg/dL or &gt; 10.2 mg/dl (as evaluated by labs taken in the&#xD;
             ER/urgent care)&#xD;
&#xD;
          4. Women who are currently breastfeeding&#xD;
&#xD;
          5. History of kidney stone in the past year or h/o multiple (&gt;1) previous kidney stones&#xD;
&#xD;
          6. Does not have a smart phone that can download apps from Google Play or App Store.&#xD;
&#xD;
          7. No way to keep the phone charged consistently&#xD;
&#xD;
          8. The smartphone is shared with another individual.&#xD;
&#xD;
          9. Required laboratory data is unavailable (eg calcium levels)&#xD;
&#xD;
         10. No new oxygen requirement (see remote monitoring document)&#xD;
&#xD;
         11. Pregnant and lactating mothers.&#xD;
&#xD;
         12. Vitamin D level of 80ng/ml and above&#xD;
&#xD;
         13. No lab work for calcium or vitamin D completed in ED&#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>Kevin Cooper, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals Cleveland Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wesley Yu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals Cleveland Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>February 4, 2022</last_update_submitted>
  <last_update_submitted_qc>February 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospitals Cleveland Medical Center</investigator_affiliation>
    <investigator_full_name>Dr. Kevin Cooper</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Vitamin D</keyword>
  <keyword>Telehealth</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Immune Storm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Severe Acute Respiratory Syndrome</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>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04489628
org study id: STUDY20200461
nct id: NCT04489628
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: Yes
To determine the efficacy of high dose Vitamin D (an over-the-counter nutritional supplement)
      in preventing immune-related complications in outpatients with confirmed SARS-CoV-2
      infection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Patients requiring admission to the hospital or experiencing death
time frame: Days 1 to 15
description: Proportion of patients requiring admission to the hospital or experiencing death by Day 15
arm group label: Vitamin D
arm group type: Active Comparator
description: Participants will be given 8 capsules of either cholecalciferol 50,000 IU or placebo at study randomization. Participants will be instructed to take 4 capsules on receipt of the treatment package(Day 0), 2 capsules on Day 5, 1 capsule on Day 10, and 1 capsule on Day 15. A phone or text reminder will be included at Days 5, 10, and 15 to take the additional doses of vitamin D.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will be given 8 capsules of either cholecalciferol 50,000 IU or placebo at study randomization. Participants will be instructed to take 4 capsules on receipt of the treatment package(Day 0), 2 capsules on Day 5, 1 capsule on Day 10, and 1 capsule on Day 15. A phone or text reminder will be included at Days 5, 10, and 15 to take the additional doses of vitamin D.
intervention type: Drug
intervention name: Vitamin D3 or Placebo
description: ): Participants will be given 8 capsules of either cholecalciferol 50,000 IU or placebo at study randomization. Participants will be instructed to take 4 capsules on receipt of the treatment package(Day 0), 2 capsules on Day 5, 1 capsule on Day 10, and 1 capsule on Day 15. A phone or text reminder will be included at Days 5, 10, and 15 to take the additional doses of vitamin D.
arm group label: Vitamin D
intervention type: Device
intervention name: Doctella telehealth monitoring
description: Doctella device will be give to participants by the Emergency department as part of usual care to monitor heart rate, respiratory rate, oxygen saturation, and perfusion index vitals continuously for approximately 10 days. The study team will receive the vitals signs data (heart rate, respiratory rate, oxygen saturation, perfusion index, and temperature) retrospectively and will not be able to monitor patients in real time.
arm group label: Placebo
arm group label: Vitamin D
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kevin Cooper, MD
role: Principal Investigator
affiliation: University Hospitals Cleveland Medical Center
last name: Wesley Yu, MD
role: Principal Investigator
affiliation: University Hospitals Cleveland Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University Hospitals Cleveland Medical Center
investigator full name: Dr. Kevin Cooper
investigator title: Principal Investigator
mesh term: Severe Acute Respiratory Syndrome
mesh term: Vitamin D
mesh term: Cholecalciferol
sharing ipd: No