<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/NCT04487951</url>
  </required_header>
  <id_info>
    <org_study_id>2020-7-1</org_study_id>
    <nct_id>NCT04487951</nct_id>
  </id_info>
  <brief_title>N-terminal Pro B-type Natriuretic Peptide and Vitamin D Levels as Prognostic Markers in COVID-19 Pneumonia</brief_title>
  <official_title>N-terminal Pro B-type Natriuretic Peptide and Vitamin D Levels as Prognostic Markers in COVID-19 Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kasr El Aini Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cairo University</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>
      This study is designed to assess the difference between level of NT-pro-BNP, and Vitmin D in&#xD;
      moderate cases who progressed to severe or critically ill category compared to those who did&#xD;
      not.&#xD;
&#xD;
      Assessment of any possible correlation between NT-pro-BNP and Vitamin D and the need for&#xD;
      mechanical ventilation or mortality in COVID-19 infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      On 30 January 2020, World Health Organization (WHO) officially declared the COVID-19 epidemic&#xD;
      as a public health emergency of international concern. An acute respiratory disease, caused&#xD;
      by a novel coronavirus (SARS-CoV-2, previously known as 2019-nCoV), the coronavirus disease&#xD;
      2019 (COVID-19) has spread throughout China and received worldwide attention (Guo et al.,&#xD;
      2020).&#xD;
&#xD;
      As an emerging acute respiratory infectious disease, COVID-19 primarily spreads through the&#xD;
      respiratory tract, by droplets, respiratory secretions, and direct contact (Li et al., 2020).&#xD;
      Based on current epidemiological investigation, the incubation period is 1-14 days, mostly&#xD;
      3-7 days and the COVID-19 is contagious during the latency period (Jin et al., 2020). The&#xD;
      common clinical manifestations included fever (88.7%), cough (67.8%), fatigue (38.1%), sputum&#xD;
      production (33.4%), shortness of breath (18.6%), sore throat (13.9%), and headache (13.6%)&#xD;
      [16]. In addition, a part of patients manifested gastrointestinal symptoms, with diarrhea&#xD;
      (3.8%) and vomiting (5.0%) (Guan et al., 2020).&#xD;
&#xD;
      B-type Natriuretic Peptide (BNP) is mainly synthesized and secreted by myocytes in the left&#xD;
      ventricle (LV) as a response to myocytes stretched by pressure overload or volume expansion&#xD;
      of the ventricle (Cao et al., 2019). In patients with Community Acquired Peumonia (CAP),&#xD;
      NT-pro BNP levels are powerful predictors of adverse cardiac events. For patients with&#xD;
      systemic inflammatory response syndrome (SIRS), Chen et al found that compared with non-SIRS&#xD;
      patients, subjects with SIRS had a markedly higher level of B-type natriuretic peptide (BNP).&#xD;
      Additionally, BNP level of more than 113 pg/mL was independent predictor of all-cause&#xD;
      mortality in septic patients. Additionally, in 302 CAP patients, Christ-Crain et al confirmed&#xD;
      that BNP levels increased with rising disease severity as classified by the pulmonary&#xD;
      severity index (PSI) (p=0.01). Li et al confirmed that BNP could be used as a biomarker for&#xD;
      evaluating the severity of CAP. They recommended BNP level of 299.0 pg/mL in predicting&#xD;
      in-hospital mortality (sensitivity 67.5%, specificity 81.6%) (Zhang et al., 2016).&#xD;
&#xD;
      In respiratory system conditions, such as influenza, vitamin D has wide-ranging and&#xD;
      fundamental roles, including through: gene transcription via COVID-19 relevant VDR (Vitamin D&#xD;
      Receptor) pathways; wider immune function; and airway epithelial cell tight-junction function&#xD;
      and integrity. Further, studies suggest vitamin D supplementation may be protective in&#xD;
      respiratory conditions, the effect being highly significant in 'D' deficient persons. It is&#xD;
      hypothesized by Watkins, 2020 and Grant et al., 2020 that vitamin D insufficiency may&#xD;
      significantly compromise, respiratory immune response function, greatly increasing risk of&#xD;
      COVID-19 severity and mortality (Brown and Sarkar, 2020).&#xD;
&#xD;
      Primary outcomes: This study is designed to assess the difference between level of&#xD;
      NT-pro-BNP, and Vitmin D in moderate cases who progressed to severe or critically ill&#xD;
      category compared to those who did not.&#xD;
&#xD;
      Secondary outcomes: Assessment of any possible correlation between NT-pro-BNP and Vitamin D&#xD;
      and the need for mechanical ventilation or mortality in COVID-19 infection.&#xD;
&#xD;
      The study will be conducted on 100 COVID-19 confirmed patients Group (1): 50 mild to moderate&#xD;
      cases (lung shadows without hypoxia and oxygen saturation &gt;92%) who progressed to severe&#xD;
      illness characterized by hypoxia necessitating oxygen therapy, or critical illness&#xD;
      characterized by respiratory failure necessitating mechanical ventilation either invasive or&#xD;
      non-invasive within their hospital stay.&#xD;
&#xD;
      Group (2): 50 mild to moderate cases who did not show clinical progression and were&#xD;
      discharged.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">January 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 1, 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>NT-pro-BNP and Vitamin D</measure>
    <time_frame>6 month</time_frame>
    <description>level of NT-pro-BNP, and Vitamin D</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of any possible correlation between NT-pro-BNP and Vitamin D and the need for mechanical ventilation or mortality in COVID-19 infection</measure>
    <time_frame>6 month</time_frame>
    <description>Assessment of any possible correlation between NT-pro-BNP and Vitamin D and the need for mechanical ventilation or mortality in COVID-19 infection</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>COVID19 Pneumonia</condition>
  <arm_group>
    <arm_group_label>Moderate</arm_group_label>
    <description>Moderate: moderate COVID -19 pneumonia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Severe</arm_group_label>
    <description>_severe COVID-19 pneumonia</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pro BNP , Vitamin D</intervention_name>
    <description>This study is designed to assess the difference between level of NT-pro-BNP, and Vitamin D in moderate cases who progressed to severe or critically ill category compared to those who did not.</description>
    <arm_group_label>Moderate</arm_group_label>
    <arm_group_label>Severe</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be conducted on 100 COVID-19 confirmed patients Group (1): 50 mild to&#xD;
        moderate cases (lung shadows without hypoxia and oxygen saturation &gt;92%) who progressed to&#xD;
        severe illness characterized by hypoxia necessitating oxygen therapy, or critical illness&#xD;
        characterized by respiratory failure necessitating mechanical ventilation either invasive&#xD;
        or non-invasive within their hospital stay.&#xD;
&#xD;
        Group (2): 50 mild to moderate cases who did not show clinical progression and were&#xD;
        discharged.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All cases will be diagnosed with COVID-19 by RT-PCR • Group (1) Critically ill&#xD;
             patients: Respiratory Rate &gt; 30/min SaO2 &lt; 92% at room temperature Chest radiology&#xD;
             showing more than 50% lesion or progressive lesion within 24 to 48 hours • Group (2)&#xD;
             moderate cases: Patients has pneumonia manifestations on radiology associated with&#xD;
             symptoms &amp;/or leucopenia or lymphopenia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other causes of pneumonia other than infection with SARS-CoV-2.&#xD;
&#xD;
               -  Concomitant heart failure.&#xD;
&#xD;
               -  Hypoxic patients on hospital admission.&#xD;
&#xD;
               -  Arrhythmia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Akram Abdelbary, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Noha A. Radwan, Lecturer of Chemical pathology</last_name>
    <phone>01152003668</phone>
    <email>nohakhaled11@cu.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yasmine Elshiwy, Ass. Prof.</last_name>
    <phone>+201005002408</phone>
    <email>yasmineelshiwy@kasralainy.edu.eg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kasr Alainy Cairo University</name>
      <address>
        <city>Cairo</city>
        <state>Giza</state>
        <zip>11562</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Noha A. Radwan, Lecturer</last_name>
      <phone>01152003668</phone>
      <email>nohakhaled11@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Noha Radwan, Lecturer</last_name>
      <phone>01152003668</phone>
      <email>nohakhaled11@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Noha A. Radwan</investigator_full_name>
    <investigator_title>Lecturer of Clinical and Chemical Pathology</investigator_title>
  </responsible_party>
  <keyword>NT-pro-BNP</keyword>
  <keyword>Vitamin D</keyword>
  <keyword>COVID-19 Pneumonia</keyword>
  <keyword>HPLC/UV Diode array</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>Vitamin D</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is not a plan to make IPD available.</ipd_description>
  </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/NCT04487951
org study id: 2020-7-1
nct id: NCT04487951
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is designed to assess the difference between level of NT-pro-BNP, and Vitmin D in
      moderate cases who progressed to severe or critically ill category compared to those who did
      not.

      Assessment of any possible correlation between NT-pro-BNP and Vitamin D and the need for
      mechanical ventilation or mortality in COVID-19 infection.
On 30 January 2020, World Health Organization (WHO) officially declared the COVID-19 epidemic
      as a public health emergency of international concern. An acute respiratory disease, caused
      by a novel coronavirus (SARS-CoV-2, previously known as 2019-nCoV), the coronavirus disease
      2019 (COVID-19) has spread throughout China and received worldwide attention (Guo et al.,
      2020).

      As an emerging acute respiratory infectious disease, COVID-19 primarily spreads through the
      respiratory tract, by droplets, respiratory secretions, and direct contact (Li et al., 2020).
      Based on current epidemiological investigation, the incubation period is 1-14 days, mostly
      3-7 days and the COVID-19 is contagious during the latency period (Jin et al., 2020). The
      common clinical manifestations included fever (88.7%), cough (67.8%), fatigue (38.1%), sputum
      production (33.4%), shortness of breath (18.6%), sore throat (13.9%), and headache (13.6%)
      [16]. In addition, a part of patients manifested gastrointestinal symptoms, with diarrhea
      (3.8%) and vomiting (5.0%) (Guan et al., 2020).

      B-type Natriuretic Peptide (BNP) is mainly synthesized and secreted by myocytes in the left
      ventricle (LV) as a response to myocytes stretched by pressure overload or volume expansion
      of the ventricle (Cao et al., 2019). In patients with Community Acquired Peumonia (CAP),
      NT-pro BNP levels are powerful predictors of adverse cardiac events. For patients with
      systemic inflammatory response syndrome (SIRS), Chen et al found that compared with non-SIRS
      patients, subjects with SIRS had a markedly higher level of B-type natriuretic peptide (BNP).
      Additionally, BNP level of more than 113 pg/mL was independent predictor of all-cause
      mortality in septic patients. Additionally, in 302 CAP patients, Christ-Crain et al confirmed
      that BNP levels increased with rising disease severity as classified by the pulmonary
      severity index (PSI) (p=0.01). Li et al confirmed that BNP could be used as a biomarker for
      evaluating the severity of CAP. They recommended BNP level of 299.0 pg/mL in predicting
      in-hospital mortality (sensitivity 67.5%, specificity 81.6%) (Zhang et al., 2016).

      In respiratory system conditions, such as influenza, vitamin D has wide-ranging and
      fundamental roles, including through: gene transcription via COVID-19 relevant VDR (Vitamin D
      Receptor) pathways; wider immune function; and airway epithelial cell tight-junction function
      and integrity. Further, studies suggest vitamin D supplementation may be protective in
      respiratory conditions, the effect being highly significant in 'D' deficient persons. It is
      hypothesized by Watkins, 2020 and Grant et al., 2020 that vitamin D insufficiency may
      significantly compromise, respiratory immune response function, greatly increasing risk of
      COVID-19 severity and mortality (Brown and Sarkar, 2020).

      Primary outcomes: This study is designed to assess the difference between level of
      NT-pro-BNP, and Vitmin D in moderate cases who progressed to severe or critically ill
      category compared to those who did not.

      Secondary outcomes: Assessment of any possible correlation between NT-pro-BNP and Vitamin D
      and the need for mechanical ventilation or mortality in COVID-19 infection.

      The study will be conducted on 100 COVID-19 confirmed patients Group (1): 50 mild to moderate
      cases (lung shadows without hypoxia and oxygen saturation >92%) who progressed to severe
      illness characterized by hypoxia necessitating oxygen therapy, or critical illness
      characterized by respiratory failure necessitating mechanical ventilation either invasive or
      non-invasive within their hospital stay.

      Group (2): 50 mild to moderate cases who did not show clinical progression and were
      discharged.
observational model: Case-Control
time perspective: Cross-Sectional
measure: NT-pro-BNP and Vitamin D
time frame: 6 month
description: level of NT-pro-BNP, and Vitamin D
measure: Assessment of any possible correlation between NT-pro-BNP and Vitamin D and the need for mechanical ventilation or mortality in COVID-19 infection
time frame: 6 month
description: Assessment of any possible correlation between NT-pro-BNP and Vitamin D and the need for mechanical ventilation or mortality in COVID-19 infection
arm group label: Moderate
description: Moderate: moderate COVID -19 pneumonia
arm group label: Severe
description: _severe COVID-19 pneumonia
intervention type: Other
intervention name: Pro BNP , Vitamin D
description: This study is designed to assess the difference between level of NT-pro-BNP, and Vitamin D in moderate cases who progressed to severe or critically ill category compared to those who did not.
arm group label: Moderate
arm group label: Severe
serum samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Akram Abdelbary, Prof.
role: Principal Investigator
affiliation: Cairo University
last name: Noha A. Radwan, Lecturer of Chemical pathology
phone: 01152003668
email: nohakhaled11@cu.edu.eg
last name: Yasmine Elshiwy, Ass. Prof.
phone: +201005002408
email: yasmineelshiwy@kasralainy.edu.eg
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Noha A. Radwan
investigator title: Lecturer of Clinical and Chemical Pathology
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Vitamin D
sharing ipd: No
ipd description: There is not a plan to make IPD available.