<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/NCT04445506</url>
  </required_header>
  <id_info>
    <org_study_id>20-027</org_study_id>
    <nct_id>NCT04445506</nct_id>
  </id_info>
  <brief_title>Short Term Corticosteroids in SARS-CoV2 Patients</brief_title>
  <official_title>The Effect of the Short-term Use of Systemic Corticosteroids in COVID-19 Patients in Regard to Hospital Length of Stay, Morbidly and/or Mortality.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Miriam Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Miriam Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators reviewed the charts of SARS-CoV-2 patients with pneumonia and moderate to&#xD;
      severely elevated CRP and worsening hypoxemia who were treated with early, short-term&#xD;
      dexamethasone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Actual">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Effect on transfers to ICU and escalation of care needing mechanical ventilation</measure>
    <time_frame>2 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect on length of stay</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CRP levels</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Corticosteroids</condition>
  <condition>Covid19</condition>
  <condition>SARS-CoV 2</condition>
  <condition>Steroids</condition>
  <condition>Dexamethasone</condition>
  <arm_group>
    <arm_group_label>SARS-CoV2 patients that received dexamethasone</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>4mg dexamethasone was given to some patients three times daily for 2 days, 2 times daily for 2 days, once daily for 2 days.</description>
    <arm_group_label>SARS-CoV2 patients that received dexamethasone</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients aged 18 years and older with positive SARS-CoV2 test with CRP greater than 50&#xD;
        mg/L and having greater than 2L Oxygen requirement&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Moderate disease with at least a 30% increase in CRP within 36 hours of admission, and&#xD;
             with increasing oxygen requirements.&#xD;
&#xD;
          2. All patients with severe disease with evidence of escalating oxygen requirements&#xD;
&#xD;
          3. The presence of secondary bacterial infections as a probable cause of increasing CRP&#xD;
             levels was excluded in all selected patients.&#xD;
&#xD;
          4. Pulmonary embolism and /or cardiac dysfunction were excluded as probable causes of&#xD;
             worsening hypoxia in all selected patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. All patients on other treatment modalities- Remdesivir and/or Convalescent plasma who&#xD;
             showed evidence of clinical improvement as per decrease in CRP levels and/or oxygen&#xD;
             requirements were excluded.&#xD;
&#xD;
          2. Patient with associated COPD exacerbation who would benefit from the use of steroids.&#xD;
&#xD;
          3. Patients with Diabetic ketoacidosis, hyperglycemic hyperosmolar state, active&#xD;
             concurrent bacterial infections.&#xD;
&#xD;
          4. Patients with history of steroid-induced mania and/or psychosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kwame Dapaah-Afriyie, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Miriam Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Miriam Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 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>Dexamethasone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04445506
org study id: 20-027
nct id: NCT04445506
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The investigators reviewed the charts of SARS-CoV-2 patients with pneumonia and moderate to
      severely elevated CRP and worsening hypoxemia who were treated with early, short-term
      dexamethasone.
observational model: Case-Control
time perspective: Retrospective
measure: Effect on transfers to ICU and escalation of care needing mechanical ventilation
time frame: 2 months
measure: Effect on length of stay
time frame: 2 months
measure: Change in CRP levels
time frame: 2 months
arm group label: SARS-CoV2 patients that received dexamethasone
intervention type: Drug
intervention name: Dexamethasone
description: 4mg dexamethasone was given to some patients three times daily for 2 days, 2 times daily for 2 days, once daily for 2 days.
arm group label: SARS-CoV2 patients that received dexamethasone
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kwame Dapaah-Afriyie, MD
role: Principal Investigator
affiliation: The Miriam Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Dexamethasone
sharing ipd: Undecided