<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/NCT04438863</url>
  </required_header>
  <id_info>
    <org_study_id>SHEBA-20-7022-SMC-LL-CTIL</org_study_id>
    <nct_id>NCT04438863</nct_id>
  </id_info>
  <brief_title>Daily Home Spirometry for Early Detection of Pulmonary Complications in Patients With COVID19</brief_title>
  <official_title>A Descriptive Pilot Study of Daily Home Spirometry for Early Detection of Pulmonary Complications in High Risk Patients With COVID19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this preliminary study is to describe the potential decline in forced expiratory&#xD;
      volume in 1 second (FEV1) or forced vital capacity (FVC) as measured by home spirometry in&#xD;
      high-risk subjects infected with COVID-19. We hypothesize that the magnitude of such a&#xD;
      decline in FEV1 and/or FVC may be associated with clinical deterioration and hospitalization.&#xD;
      The study will ultimately inform a larger subsequent RCT that will evaluate the efficacy of&#xD;
      home spirometry in the early detection (pre respiratory symptoms) of respiratory&#xD;
      complications and therefore prompt early medical attention which is a key for improving&#xD;
      outcome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 8, 2020</start_date>
  <completion_date type="Anticipated">January 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hospitalization</measure>
    <time_frame>number of participants hospitalized in a time frame of a year</time_frame>
    <description>participants that are hospitalized</description>
  </primary_outcome>
  <enrollment type="Anticipated">90</enrollment>
  <condition>COVID 19</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>home spirometry</intervention_name>
    <description>portable hand-held spirometer to collect and store daily spirometric data (including FVC, FEV1, forced expiratory flow after 25 to 75% of vital capacity has been expelled, and peak flow).</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        confirmed COVID19 patients (hospitalized or not hospitalized) with mild to moderate&#xD;
        symptoms.&#xD;
&#xD;
        (low grade fever, cough, anosmia, fatigue, discomfort, anorexia or other gastrointestinal&#xD;
        symptoms)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. without dyspnea and with no evidence of pneumonia, ARDS, organ failure or requiring&#xD;
             admission to ICU.&#xD;
&#xD;
          2. All patients ≥55 years age or ≥1 risk factor for disease complications (prior&#xD;
             pulmonary, kidney or cardiovascular disease, diabetes mellitus, hypertension, bone&#xD;
             merrow suppression, solid organ transplant, HIV with CD4&lt;250, heavy smoker, BMI &gt;30).&#xD;
             All participants will sign a written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients unable to perform spirometry&#xD;
&#xD;
          2. contraindications for spirometry (hemoptysis, active tuberculosis, syncope associated&#xD;
             with forced exhalation or increased risk for spirometry)&#xD;
&#xD;
          3. adhere to the follow-up protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Gal Varshavsky</last_name>
    <phone>972-3-5305997</phone>
    <email>Gal.Varshavsky@sheba.health.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gal Varshavsky</last_name>
      <phone>972-3-5305997</phone>
      <email>Gal.Varshavsky@sheba.health.gov.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>November 25, 2021</last_update_submitted>
  <last_update_submitted_qc>November 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sheba Medical Center</investigator_affiliation>
    <investigator_full_name>Dr. Liran Levy</investigator_full_name>
    <investigator_title>Transplant pulmonologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>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/NCT04438863
org study id: SHEBA-20-7022-SMC-LL-CTIL
nct id: NCT04438863
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this preliminary study is to describe the potential decline in forced expiratory
      volume in 1 second (FEV1) or forced vital capacity (FVC) as measured by home spirometry in
      high-risk subjects infected with COVID-19. We hypothesize that the magnitude of such a
      decline in FEV1 and/or FVC may be associated with clinical deterioration and hospitalization.
      The study will ultimately inform a larger subsequent RCT that will evaluate the efficacy of
      home spirometry in the early detection (pre respiratory symptoms) of respiratory
      complications and therefore prompt early medical attention which is a key for improving
      outcome.
observational model: Cohort
time perspective: Prospective
measure: Hospitalization
time frame: number of participants hospitalized in a time frame of a year
description: participants that are hospitalized
intervention type: Diagnostic Test
intervention name: home spirometry
description: portable hand-held spirometer to collect and store daily spirometric data (including FVC, FEV1, forced expiratory flow after 25 to 75% of vital capacity has been expelled, and peak flow).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Gal Varshavsky
phone: 972-3-5305997
email: Gal.Varshavsky@sheba.health.gov.il
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Sheba Medical Center
investigator full name: Dr. Liran Levy
investigator title: Transplant pulmonologist
mesh term: COVID-19
sharing ipd: No