<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/NCT04456101</url>
  </required_header>
  <id_info>
    <org_study_id>NCIP03</org_study_id>
    <nct_id>NCT04456101</nct_id>
  </id_info>
  <brief_title>Study on the Recovery of Pulmonary Function, Chest CT, Airway Microbiota, Hematologic, and Immune &amp; Inflammatory Conditions in COVID-19 Rehabilitation Patients</brief_title>
  <official_title>Union Hospital, Tongji Medical College, Huazhong University of Science and Technology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wuhan Union Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wuhan Union Hospital, China</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 intent of this study was to examine the health status of individuals who had been&#xD;
      confirmed with COVID-19 in the year after their recovery. Parameters studied included serum&#xD;
      levels of SARS coronavirus 2 (SARS-CoV 2) IgG antibody, SARS-CoV-2 nucleic acid test,&#xD;
      hematology indicators (blood routine, liver function, kidney function, myocardial enzymes,&#xD;
      coagulation function, etc), lung function test, imaging data and airway microbiota data. In&#xD;
      addition, we explored the systematic Immune &amp; Inflammation in some of the individuals&#xD;
      recovering from COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      About 20% of COVID-19 developed into a critical illness and about 2% died. The global&#xD;
      epidemic continues to develop, but some patients in China have entered the rehabilitation&#xD;
      period, which is accompanied by a large number of respiratory symptoms and pulmonary&#xD;
      fibrosis, bringing serious harm to the country. Therefore, early accurate detection and&#xD;
      prediction of the development trend of patients in rehabilitation period and targeted&#xD;
      treatment measures for corresponding patients are the key to the success of COVID-19&#xD;
      rehabilitation period. It will play a key role in the stratified management of the&#xD;
      post-epidemic situation, which is crucial to improve the quality of life of COVID-19&#xD;
      patients. We aim to explore the clinical characteristics of rehabilitation patients by&#xD;
      detecting some indicators of patients in rehabilitation period, including serum IgG and IgM&#xD;
      antibody of SARS-CoV 2, SARS-CoV-2 nucleic acid, hematology indicators (blood routine, liver&#xD;
      function, kidney function, myocardial enzymes, coagulation function, etc), pulmonary&#xD;
      function, chest CT imaging, systematic Immune &amp; Inflammation states.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 19, 2020</start_date>
  <completion_date type="Anticipated">December 12, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 12, 2023</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>Pulmonary Function</measure>
    <time_frame>an average of 1 to 3 months after recovery</time_frame>
    <description>Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) for lung volume, peak expiratory flow (PEF) for velocity, carbon monoxide diffusion capacity (DLCO) for pulmonary diffusion function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chest CT</measure>
    <time_frame>an average of 1 to 3 months after recovery</time_frame>
    <description>Percentage of lungs that contain reticular patterns, Percentage of lungs that contain pure ground-glass opacification, Percentage of lungs that contain honeycombing, Percentage of lungs that contain traction bronchiectasis, Percentage of lungs that contain strip-like consolidation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in hematology</measure>
    <time_frame>an average of 1 to 3 months after recovery</time_frame>
    <description>blood routine indexes included leucocytes(×109/L), neutrophils(×109/L), lymphocytes(×109/L), monocytes(×109/L), eosinophils(×109/L), platelets(×109/L). Biochemical and coagulation function indicators included total protein(umol/L), creatinine (umol/L), uric acid (umol/L), lactic dehydrogenase(U/L), C-reactive protein (mg/L), aspartate aminotransferase (U/L), glutamic-pyruvic transaminase (U/L), D-dimer,(ug/L), fibrinogen(g/L), Active part thrombin time (APTT), prothrombin time (PT), thrombin time (TT) and troponin (TNI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in immune and inflammatory states</measure>
    <time_frame>an average of 1 to 3 months after recovery</time_frame>
    <description>Immune cells and related cell factors included CD8+T cell(×109/L), CD4+T cell(×109/L), bone marrow derived suppressor cells(×109/L), regulatory T cells(×109/L), natural killer cell(×109/L), dendritic cell(×109/L), macrophages(×109/L), interleukin-4(IL-4)ug/L, IL-2 ug/L, IL-17 ug/L, IL-15 ug/L, IL-16 ug/L, IL-1 ug/L, IL-6 ug/L, IL-10 ug/L, tumor necrosis factor ug/L, interferon gamma ug/L, eotaxin-3 ug/L, eotaxin ug/L.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>St. George's Respiratory Questionnaire(SGRQ)</measure>
    <time_frame>an average of 1 to 3 months after recovery</time_frame>
    <description>St. George's Respiratory Questionnaire total score(0-3989.4), St. George's Respiratory Questionnaire symptoms score(0-662.5); St. George's Respiratory Questionnaire impacts score(0-2117.8); St. George's Respiratory Questionnaire activity score(0-1209.1). The higher the score, the worse the lung.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified British medical research council (mMRC)</measure>
    <time_frame>an average of 1 to 3 months after recovery</time_frame>
    <description>mMRC only reflects symptom of dyspnea. A score of 0-1 is considered as fewer symptom, and ≥2 is considered as more symptom.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>COPD Assessment test (CAT)</measure>
    <time_frame>an average of 1 to 3 months after recovery</time_frame>
    <description>CAT score was a comprehensive symptom score ranging from 0 to 40 points. The higher the score, the worse the lung.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Airway Microbiota</measure>
    <time_frame>an average of 1 to 3 months after recovery</time_frame>
    <description>Airway Microbiota of exhaled breath condensate in individuals were detected.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">450</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>healthy individuals without COVID-19</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Severe/Critical COVID-19 rehabilitation group</arm_group_label>
    <description>①Individuals recovering from Severe/Critical COVID-19</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mild/moderate COVID-19 rehabilitation group</arm_group_label>
    <description>Individuals recovering from mild/moderate COVID-19</description>
  </arm_group>
  <arm_group>
    <arm_group_label>asymptomatic COVID-19 rehabilitation group</arm_group_label>
    <description>Asymptomatic COVID-19 individuals with laboratory test for SRARS-COV2 turning negative</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Covid-19 rehabilitation was the experimental group, and the healthy control group was the&#xD;
        conventional control group&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Individuals recovering from COVID-19, or asymptomatic COVID-19 patients with&#xD;
             laboratory test for SRARS-COV2 turning negative, or healthy volunteers without&#xD;
             COVID-19.&#xD;
&#xD;
          2. The age range is 18-80 years.&#xD;
&#xD;
          3. Subjects or their family members agree to participate in the study and sign informed&#xD;
             consent.&#xD;
&#xD;
          4. The previously diagnosed individuals have been cured for about 1 month.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Woman who is breastfeeding, pregnant, or preparing to become pregnant.&#xD;
&#xD;
          2. Patients with cognitive impairment or poor compliance as determined by the&#xD;
             investigator.&#xD;
&#xD;
          3. Participants in other clinical trials.&#xD;
&#xD;
          4. Subjects who were not suitable for clinical trials determined by the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yang Jin, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wuhan Union Hospital, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Juanjuan Xu, professor</last_name>
    <phone>15972930101</phone>
    <email>whuhjy@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Union Hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yang Jin, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wuhan Union Hospital, China</investigator_affiliation>
    <investigator_full_name>Yang Jin</investigator_full_name>
    <investigator_title>Department of Respiratory and Critical Care Medicine</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/NCT04456101
org study id: NCIP03
nct id: NCT04456101
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The intent of this study was to examine the health status of individuals who had been
      confirmed with COVID-19 in the year after their recovery. Parameters studied included serum
      levels of SARS coronavirus 2 (SARS-CoV 2) IgG antibody, SARS-CoV-2 nucleic acid test,
      hematology indicators (blood routine, liver function, kidney function, myocardial enzymes,
      coagulation function, etc), lung function test, imaging data and airway microbiota data. In
      addition, we explored the systematic Immune & Inflammation in some of the individuals
      recovering from COVID-19.
About 20% of COVID-19 developed into a critical illness and about 2% died. The global
      epidemic continues to develop, but some patients in China have entered the rehabilitation
      period, which is accompanied by a large number of respiratory symptoms and pulmonary
      fibrosis, bringing serious harm to the country. Therefore, early accurate detection and
      prediction of the development trend of patients in rehabilitation period and targeted
      treatment measures for corresponding patients are the key to the success of COVID-19
      rehabilitation period. It will play a key role in the stratified management of the
      post-epidemic situation, which is crucial to improve the quality of life of COVID-19
      patients. We aim to explore the clinical characteristics of rehabilitation patients by
      detecting some indicators of patients in rehabilitation period, including serum IgG and IgM
      antibody of SARS-CoV 2, SARS-CoV-2 nucleic acid, hematology indicators (blood routine, liver
      function, kidney function, myocardial enzymes, coagulation function, etc), pulmonary
      function, chest CT imaging, systematic Immune & Inflammation states.
observational model: Cohort
time perspective: Prospective
measure: Pulmonary Function
time frame: an average of 1 to 3 months after recovery
description: Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) for lung volume, peak expiratory flow (PEF) for velocity, carbon monoxide diffusion capacity (DLCO) for pulmonary diffusion function.
measure: Chest CT
time frame: an average of 1 to 3 months after recovery
description: Percentage of lungs that contain reticular patterns, Percentage of lungs that contain pure ground-glass opacification, Percentage of lungs that contain honeycombing, Percentage of lungs that contain traction bronchiectasis, Percentage of lungs that contain strip-like consolidation.
measure: Changes in hematology
time frame: an average of 1 to 3 months after recovery
description: blood routine indexes included leucocytes(×109/L), neutrophils(×109/L), lymphocytes(×109/L), monocytes(×109/L), eosinophils(×109/L), platelets(×109/L). Biochemical and coagulation function indicators included total protein(umol/L), creatinine (umol/L), uric acid (umol/L), lactic dehydrogenase(U/L), C-reactive protein (mg/L), aspartate aminotransferase (U/L), glutamic-pyruvic transaminase (U/L), D-dimer,(ug/L), fibrinogen(g/L), Active part thrombin time (APTT), prothrombin time (PT), thrombin time (TT) and troponin (TNI).
measure: Changes in immune and inflammatory states
time frame: an average of 1 to 3 months after recovery
description: Immune cells and related cell factors included CD8+T cell(×109/L), CD4+T cell(×109/L), bone marrow derived suppressor cells(×109/L), regulatory T cells(×109/L), natural killer cell(×109/L), dendritic cell(×109/L), macrophages(×109/L), interleukin-4(IL-4)ug/L, IL-2 ug/L, IL-17 ug/L, IL-15 ug/L, IL-16 ug/L, IL-1 ug/L, IL-6 ug/L, IL-10 ug/L, tumor necrosis factor ug/L, interferon gamma ug/L, eotaxin-3 ug/L, eotaxin ug/L.
measure: St. George's Respiratory Questionnaire(SGRQ)
time frame: an average of 1 to 3 months after recovery
description: St. George's Respiratory Questionnaire total score(0-3989.4), St. George's Respiratory Questionnaire symptoms score(0-662.5); St. George's Respiratory Questionnaire impacts score(0-2117.8); St. George's Respiratory Questionnaire activity score(0-1209.1). The higher the score, the worse the lung.
measure: Modified British medical research council (mMRC)
time frame: an average of 1 to 3 months after recovery
description: mMRC only reflects symptom of dyspnea. A score of 0-1 is considered as fewer symptom, and ≥2 is considered as more symptom.
measure: COPD Assessment test (CAT)
time frame: an average of 1 to 3 months after recovery
description: CAT score was a comprehensive symptom score ranging from 0 to 40 points. The higher the score, the worse the lung.
measure: Airway Microbiota
time frame: an average of 1 to 3 months after recovery
description: Airway Microbiota of exhaled breath condensate in individuals were detected.
arm group label: Control group
description: healthy individuals without COVID-19
arm group label: Severe/Critical COVID-19 rehabilitation group
description: ①Individuals recovering from Severe/Critical COVID-19
arm group label: mild/moderate COVID-19 rehabilitation group
description: Individuals recovering from mild/moderate COVID-19
arm group label: asymptomatic COVID-19 rehabilitation group
description: Asymptomatic COVID-19 individuals with laboratory test for SRARS-COV2 turning negative
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yang Jin, professor
role: Principal Investigator
affiliation: Wuhan Union Hospital, China
last name: Juanjuan Xu, professor
phone: 15972930101
email: whuhjy@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Wuhan Union Hospital, China
investigator full name: Yang Jin
investigator title: Department of Respiratory and Critical Care Medicine
mesh term: COVID-19
sharing ipd: No