<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/NCT04429867</url>
  </required_header>
  <id_info>
    <org_study_id>1604885</org_study_id>
    <nct_id>NCT04429867</nct_id>
  </id_info>
  <brief_title>Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease</brief_title>
  <official_title>Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>WellStar Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>WellStar Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to assess the impact of hydroxychloroquine in hospitalized patients&#xD;
      with COVID-19 and risk factors for severe/critical disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will utilize a randomized, placebo-controlled, double-blinded design. Patients&#xD;
      admitted with confirmed COVID-19, and at least 1 of the following: requiring oxygen&#xD;
      supplementation (≤4 liters of oxygen via nasal cannula or increase from baseline), bilateral&#xD;
      infiltrates on CT/CXR, age &gt;65, diabetes, hypertension, BMI &gt; 35, chronic lung disease,&#xD;
      cardiovascular disease, chronic kidney disease, cancer (hematologic malignancies, lung&#xD;
      cancer, and metastatic disease), will be randomized in a 1:1 fashion to hydroxychloroquine&#xD;
      400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses or placebo at a matching schedule.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 7, 2020</start_date>
  <completion_date type="Anticipated">December 7, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 7, 2020</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.</measure>
    <time_frame>30 Days</time_frame>
    <description>The impact will be evaluated by comparing rates of a composite primary outcome in patients randomized to hydroxychloroquine versus those randomized to placebo. The composite outcome includes progression to severe/critical disease or death (including withdrawal of care/hospice transfer). Progression to severe/critical disease is defined by requiring oxygen delivery via high flow nasal cannula, non-rebreather mask, bipap, or transfer to intensive care (ICU) or intermediate care units (IMCU) due to COVID-19-related complications.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>30 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-Day Mortality</measure>
    <time_frame>30 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resolution of Symptoms</measure>
    <time_frame>14 Days</time_frame>
    <description>Resolution of symptoms will be assessed using standard medical interview procedures with the subject and review of the medical records.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of QTc &gt;500ms after initiation of therapy</measure>
    <time_frame>30 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of discontinuation of therapy</measure>
    <time_frame>30 Days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">700</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Hydroxychloroquine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydroxychloroquine</intervention_name>
    <description>Hydroxychloroquine 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses</description>
    <arm_group_label>Hydroxychloroquine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admitted to Wellstar Kennestone Hospital&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Laboratory-confirmed COVID-19&#xD;
&#xD;
          -  At least 1 of the following:&#xD;
&#xD;
               1. Requiring oxygen supplementation at ≤ 4 liters via nasal cannula or increase from&#xD;
                  baseline&#xD;
&#xD;
               2. Bilateral infiltrates on CXR or CT of chest&#xD;
&#xD;
               3. Age 65 or older&#xD;
&#xD;
               4. Diabetes&#xD;
&#xD;
               5. Hypertension&#xD;
&#xD;
               6. BMI &gt; 35&#xD;
&#xD;
               7. Chronic lung disease&#xD;
&#xD;
               8. Cardiovascular disease&#xD;
&#xD;
               9. Chronic kidney disease&#xD;
&#xD;
              10. Cancer (hematologic malignancies, lung cancer, and metastatic disease)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  Unable to take oral medication&#xD;
&#xD;
          -  Severe/critical COVID-19 disease at presentation&#xD;
&#xD;
               1. Intensive care or intermediate care required at admission or within 48 hours&#xD;
&#xD;
               2. Requiring oxygen supplementation via high flow nasal cannula, bipap, or&#xD;
                  non-rebreather mask at admission or within 48 hours&#xD;
&#xD;
          -  Likelihood of survival &lt;48 hours in the opinion of the primary physician or&#xD;
             transitioned to comfort measures within 48 hours of admission&#xD;
&#xD;
          -  Inability to take hydroxychloroquine due to allergy, QTc &gt; 500 ms (male) or 520 ms&#xD;
             (female) prior to initiation of hydroxychloroquine, pre-existing retinopathy, known&#xD;
             G6PD deficiency, known porphyria, or significant drug- drug interactions&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Severe liver disease (Child-Pugh Class C)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Wellstar Kennestone Hospital</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Hydroxychloroquine</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/NCT04429867
org study id: 1604885
nct id: NCT04429867
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The primary objective is to assess the impact of hydroxychloroquine in hospitalized patients
      with COVID-19 and risk factors for severe/critical disease.
This study will utilize a randomized, placebo-controlled, double-blinded design. Patients
      admitted with confirmed COVID-19, and at least 1 of the following: requiring oxygen
      supplementation (≤4 liters of oxygen via nasal cannula or increase from baseline), bilateral
      infiltrates on CT/CXR, age >65, diabetes, hypertension, BMI > 35, chronic lung disease,
      cardiovascular disease, chronic kidney disease, cancer (hematologic malignancies, lung
      cancer, and metastatic disease), will be randomized in a 1:1 fashion to hydroxychloroquine
      400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses or placebo at a matching schedule.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.
time frame: 30 Days
description: The impact will be evaluated by comparing rates of a composite primary outcome in patients randomized to hydroxychloroquine versus those randomized to placebo. The composite outcome includes progression to severe/critical disease or death (including withdrawal of care/hospice transfer). Progression to severe/critical disease is defined by requiring oxygen delivery via high flow nasal cannula, non-rebreather mask, bipap, or transfer to intensive care (ICU) or intermediate care units (IMCU) due to COVID-19-related complications.
measure: Hospital length of stay
time frame: 30 Days
measure: 30-Day Mortality
time frame: 30 Days
measure: Resolution of Symptoms
time frame: 14 Days
description: Resolution of symptoms will be assessed using standard medical interview procedures with the subject and review of the medical records.
measure: Incidence of QTc >500ms after initiation of therapy
time frame: 30 Days
measure: Incidence of discontinuation of therapy
time frame: 30 Days
arm group label: Hydroxychloroquine
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Hydroxychloroquine
description: Hydroxychloroquine 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses
arm group label: Hydroxychloroquine
intervention type: Drug
intervention name: Placebo
description: Placebo 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Hydroxychloroquine
sharing ipd: No