xml: <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/NCT06022198</url>
    </required_header>
    <id_info>
      <org_study_id>MD.21.01.408</org_study_id>
      <nct_id>NCT06022198</nct_id>
    </id_info>
    <brief_title>Bronchoalveolar Lavage in Recovered From COVID-19 Pneumonia</brief_title>
    <official_title>Study of Bronchoalveolar Lavage in Patients Recovered From COVID-19 Pneumonia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mohamed Abd Elmoniem Mohamed</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Marwa Salah Abdelrazek Ghanem</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Mohammad Khairy El-Badrawy</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Tamer Ali Elhadidy</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Dalia Abdellateif Abdelghany</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Mansoura University Hospital</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>
        Coronaviruses such as SARS-CoV2, MERS-CoV, and SARS-CoV can cause significant morbidity and&#xD;
        mortality in infected persons. Lung is the most common site of infection for these viruses,&#xD;
        which may manifest as acute respiratory distress syndrome and mortality. Pulmonary&#xD;
        involvement is also responsible for the high viral transmission The aim of this study is to&#xD;
        evaluate BAL in post-acute COVID-19 patients for:Cytological and cellular patterns. Microbial&#xD;
        analysis for possibility of presence of bacterial, mycobacerial or fungal co-infection.PCR&#xD;
        for corona virus&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        On December 31, 2019, a cluster of cases of pneumonia in people who were later linked to&#xD;
        Wuhan Seafood Market in Wuhan, Hubei, China, were reported. Just a week later, Chinese health&#xD;
        authorities confirmed that those cases were caused by a novel coronavirus, later named as&#xD;
        SARS-CoV2 .&#xD;
  &#xD;
        Till date, six coronavirus species are known to cause human diseases. Four of the&#xD;
        already-known coronavirus species, i.e., 229E, OC43, NL63, and HKU1, are commonly circulating&#xD;
        viruses in human population and cause mild common cold-like symptoms.&#xD;
  &#xD;
        Two of the already-known strains of coronavirus, severe acute respiratory&#xD;
        syndrome-coronavirus (SARS-CoV) and Middle East respiratory syndrome-CoV (MERS-CoV) are&#xD;
        zoonotic in origin and cause serious illnesses which can be fatal.&#xD;
  &#xD;
        Coronaviruses such as SARS-CoV2, MERS-CoV, and SARS-CoV can cause significant morbidity and&#xD;
        mortality in infected persons. Lung is the most common site of infection for these viruses,&#xD;
        which may manifest as acute respiratory distress syndrome and mortality. Pulmonary&#xD;
        involvement is also responsible for the high viral transmission.&#xD;
  &#xD;
        BAL, bronchial wash, and protected specimen brush are bronchoscopic procedures used to&#xD;
        provide microbiological samples from lower respiratory airways. However, because of the risk&#xD;
        of viral transmission, bronchoscopy is not routinely indicated for the diagnosis of COVID-19.&#xD;
  &#xD;
        Even if SARS-CoV-2 shares similarities with the other coronaviruses, the higher diffusion&#xD;
        rate and the possibility to induce fatal complications, such as severe pneumonia, acute&#xD;
        respiratory distress syndrome (ARDS), thrombosis, septic shock and organ failure, make this&#xD;
        virus a major public health threat.&#xD;
  &#xD;
        Since the first guidelines for autopsy on both confirmed and suspected COVID-19-positive&#xD;
        patients were published in February 2020, an increasing number of biopsies and autopsies have&#xD;
        been performed. However, our knowledge regarding the precise nature of the immunological&#xD;
        defense in various organ systems in response to viral infection, as well as the response&#xD;
        patterns in specific tissues, is largely incomplete but is essential in order to initiate&#xD;
        timely and targeted antiviral, anti-inflammatory, anticoagulative, or even antifibrotic&#xD;
        therapy .&#xD;
  &#xD;
        As of yet, most research papers have focused on the inflammatory status at the plasma level&#xD;
        of COVID-19 patients. However, because the main target organ is the lung, it is crucial to&#xD;
        understand the inflammatory status at the deep lung level during different stages of the&#xD;
        infection. Currently, limited data are available about alveolar inflammatory status in&#xD;
        COVID-19 patients because of concerns in relation to using bronchoscopy to avoid aerosol&#xD;
        generation. The aim of this study is to evaluate BAL in post-acute COVID-19 patients&#xD;
        for:Cytological and cellular patterns. Microbial analysis for possibility of presence of&#xD;
        bacterial, mycobacerial or fungal co-infection.PCR for corona virus&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2021</start_date>
    <completion_date type="Actual">January 1, 2023</completion_date>
    <primary_completion_date type="Actual">January 1, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>prospective cross sectional study at which COVID-19 patients with persistent pulmonary infiltrate one month after discharge from isolation department at Mansoura university hospitals will be enrolled in the study</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>evaluate BAL in post-acute COVID-19 patients</measure>
      <time_frame>Baseline</time_frame>
      <description>Understanding the pathophysiological mechanisms of COVID-19 and nature of the immunological defense in lungs in response to viral infection by SARS-CoV2 is essential in order to initiate timely and targeted anti-inflammatory, anticoagulative, or even antifibrotic therapy</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">50</enrollment>
    <condition>Bronchoalveolar Lavage</condition>
    <arm_group>
      <arm_group_label>Recovered From COVID-19 Pneumonia</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Bronchoalveolar Lavage in Recovered From COVID-19 Pneumonia</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Bronchoalveolar Lavage</intervention_name>
      <description>Bronchoalveolar Lavage</description>
      <arm_group_label>Recovered From COVID-19 Pneumonia</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with persistent pulmonary infiltrate one month after discharge from isolation&#xD;
               building at Mansoura university hospitals, previously tested positive for SARS-CoV-2&#xD;
               infection by real-time PCR on nasopharyngeal swab during admission, discharged and&#xD;
               discontinued transmission based precautions according to CDC guidance:&#xD;
  &#xD;
          Symptom-Based Strategy for Discontinuing Transmission-Based Precautions (CDC, 2020)&#xD;
  &#xD;
          Patients with mild to moderate illness who are not severely immunocompromised:&#xD;
  &#xD;
            -  At least 10 days have passed since symptoms first appeared and&#xD;
  &#xD;
            -  At least 24 hours have passed since last fever without the use of fever-reducing&#xD;
               medications and&#xD;
  &#xD;
            -  Symptoms (e.g., cough, shortness of breath) have improved&#xD;
  &#xD;
          Patients with severe to critical illness or who are severely immunocompromised1:&#xD;
  &#xD;
            -  At least 10 days and up to 20 days have passed since symptoms first appeared and&#xD;
  &#xD;
            -  At least 24 hours have passed since last fever without the use of fever-reducing&#xD;
               medications and&#xD;
  &#xD;
            -  Symptoms (e.g., cough, shortness of breath) have improved&#xD;
  &#xD;
            -  Consider consultation with infection control experts&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age: patients less than 18 years old.&#xD;
  &#xD;
            -  Patient refuse to undergo bronchoscopy.&#xD;
  &#xD;
            -  Patients unfit for bronchoscopy (hemodynamic instability, recent myocardial&#xD;
               infarction, severe hypoxia, uncooperative patient, severe bleeding disorder).&#xD;
  &#xD;
            -  Patients known to have chronic airway pulmonary diseases or interstitial lung diseases&#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>Marwa Ghanem</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mansoura university Faculty of medicine</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Mohamed AbdElmoniem</name>
        <address>
          <city>Mansoura</city>
          <zip>35516</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Mansoura University Hospital</investigator_affiliation>
      <investigator_full_name>Mohamed Abd Elmoniem Mohamed</investigator_full_name>
      <investigator_title>Assistant lecturer</investigator_title>
    </responsible_party>
    <keyword>Bronchoalveolar lavage</keyword>
    <keyword>COVID-19 Pneumonia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
      <mesh_term>Pneumonia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dimercaprol</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06022198
  org study id: MD.21.01.408
  nct id: NCT06022198
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Coronaviruses such as SARS-CoV2, MERS-CoV, and SARS-CoV can cause significant morbidity and
        mortality in infected persons. Lung is the most common site of infection for these viruses,
        which may manifest as acute respiratory distress syndrome and mortality. Pulmonary
        involvement is also responsible for the high viral transmission The aim of this study is to
        evaluate BAL in post-acute COVID-19 patients for:Cytological and cellular patterns. Microbial
        analysis for possibility of presence of bacterial, mycobacerial or fungal co-infection.PCR
        for corona virus
  On December 31, 2019, a cluster of cases of pneumonia in people who were later linked to
        Wuhan Seafood Market in Wuhan, Hubei, China, were reported. Just a week later, Chinese health
        authorities confirmed that those cases were caused by a novel coronavirus, later named as
        SARS-CoV2 .
  
        Till date, six coronavirus species are known to cause human diseases. Four of the
        already-known coronavirus species, i.e., 229E, OC43, NL63, and HKU1, are commonly circulating
        viruses in human population and cause mild common cold-like symptoms.
  
        Two of the already-known strains of coronavirus, severe acute respiratory
        syndrome-coronavirus (SARS-CoV) and Middle East respiratory syndrome-CoV (MERS-CoV) are
        zoonotic in origin and cause serious illnesses which can be fatal.
  
        Coronaviruses such as SARS-CoV2, MERS-CoV, and SARS-CoV can cause significant morbidity and
        mortality in infected persons. Lung is the most common site of infection for these viruses,
        which may manifest as acute respiratory distress syndrome and mortality. Pulmonary
        involvement is also responsible for the high viral transmission.
  
        BAL, bronchial wash, and protected specimen brush are bronchoscopic procedures used to
        provide microbiological samples from lower respiratory airways. However, because of the risk
        of viral transmission, bronchoscopy is not routinely indicated for the diagnosis of COVID-19.
  
        Even if SARS-CoV-2 shares similarities with the other coronaviruses, the higher diffusion
        rate and the possibility to induce fatal complications, such as severe pneumonia, acute
        respiratory distress syndrome (ARDS), thrombosis, septic shock and organ failure, make this
        virus a major public health threat.
  
        Since the first guidelines for autopsy on both confirmed and suspected COVID-19-positive
        patients were published in February 2020, an increasing number of biopsies and autopsies have
        been performed. However, our knowledge regarding the precise nature of the immunological
        defense in various organ systems in response to viral infection, as well as the response
        patterns in specific tissues, is largely incomplete but is essential in order to initiate
        timely and targeted antiviral, anti-inflammatory, anticoagulative, or even antifibrotic
        therapy .
  
        As of yet, most research papers have focused on the inflammatory status at the plasma level
        of COVID-19 patients. However, because the main target organ is the lung, it is crucial to
        understand the inflammatory status at the deep lung level during different stages of the
        infection. Currently, limited data are available about alveolar inflammatory status in
        COVID-19 patients because of concerns in relation to using bronchoscopy to avoid aerosol
        generation. The aim of this study is to evaluate BAL in post-acute COVID-19 patients
        for:Cytological and cellular patterns. Microbial analysis for possibility of presence of
        bacterial, mycobacerial or fungal co-infection.PCR for corona virus
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: prospective cross sectional study at which COVID-19 patients with persistent pulmonary infiltrate one month after discharge from isolation department at Mansoura university hospitals will be enrolled in the study
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: evaluate BAL in post-acute COVID-19 patients
  time frame: Baseline
  description: Understanding the pathophysiological mechanisms of COVID-19 and nature of the immunological defense in lungs in response to viral infection by SARS-CoV2 is essential in order to initiate timely and targeted anti-inflammatory, anticoagulative, or even antifibrotic therapy
  arm group label: Recovered From COVID-19 Pneumonia
  arm group type: Experimental
  description: Bronchoalveolar Lavage in Recovered From COVID-19 Pneumonia
  intervention type: Procedure
  intervention name: Bronchoalveolar Lavage
  description: Bronchoalveolar Lavage
  arm group label: Recovered From COVID-19 Pneumonia
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Marwa Ghanem
  role: Principal Investigator
  affiliation: Mansoura university Faculty of medicine
  facility: 
  country: Egypt
  responsible party type: Sponsor-Investigator
  investigator affiliation: Mansoura University Hospital
  investigator full name: Mohamed Abd Elmoniem Mohamed
  investigator title: Assistant lecturer
  mesh term: COVID-19
  mesh term: Pneumonia
  mesh term: Dimercaprol
  sharing ipd: No