<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/NCT04413045</url>
  </required_header>
  <id_info>
    <org_study_id>Novel COVID-19 Prevalence</org_study_id>
    <nct_id>NCT04413045</nct_id>
  </id_info>
  <brief_title>Novel COVID-19, A National Analysis</brief_title>
  <official_title>Prevalence and Clinical Characteristics of Novel COVID-19 Cases at One Quarantine Hospital; a National Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pneumonia is a form of acute respiratory tract infection (ARTI) that affects the lungs. When&#xD;
      an individual has pneumonia, the alveoli in the lungs are filled with pus and fluid, which&#xD;
      makes breathing painful and limits oxygen intake. Pneumonia has many possible causes, but the&#xD;
      most common are bacteria and viruses but nowadays there is a pandemic spread from novel&#xD;
      corona virus which cause corona virus disease 2019 (COVID-19).&#xD;
&#xD;
      Corona virus comprises of a large family of viruses that are common in human beings as well&#xD;
      animals (camels, cattle, cats, and bats). There are seven different strains of corona virus.&#xD;
      Sometimes corona virus from animals infect people and spread further via human to human&#xD;
      transmission such as with MERS-CoV, SARS-CoV, and now with this COVID-19 (Corona disease&#xD;
      2019). The virus that causes COVID-19 is designated as severe acute respiratory syndrome&#xD;
      corona virus 2 (SARS-CoV-2); previously, referred to as 2019-nCoV.&#xD;
&#xD;
      On Towards December 2019, this novel corona virus was identified as a cause of upper and&#xD;
      lower respiratory tract infections in Wuhan, a city in the Hubei Province of China. It&#xD;
      rapidly spread, resulting in an epidemic throughout China and then gradually spreading to&#xD;
      other parts of the world in pandemic proportions. It has affected almost every continent in&#xD;
      this world. In February 2020, the World Health Organization designated the disease COVID-19,&#xD;
      which stands for corona virus disease 2019.&#xD;
&#xD;
      The Coronaviruses are a large family of single-stranded RNA viruses (+ssRNA) that can be&#xD;
      isolated in different animal species. They have a crown-like appearance under an electron&#xD;
      microscope (coronam is the Latin term for crown) due to the presence of spike glycoproteins&#xD;
      on the envelope. These viruses can also infect humans and cause illness ranging from the&#xD;
      common cold to more severe diseases such as MERS, SARS and now COVID-19. According to recent&#xD;
      research, a spike mutation, which probably occurred in late November 2019, triggered jumping&#xD;
      to humans.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be done at one quarantine hospital in Assiut, Egypt. After approval from our&#xD;
      Institutional Ethics Committee, a written informed consent will be obtained from all patients&#xD;
      or their legal representatives (if they are unable to provide consent) before enrollment in&#xD;
      the study.&#xD;
&#xD;
      Study Design and Sample Size Calculation: This study is an investigator-initiated cross&#xD;
      sectional trial to record, assess the clinical manifestations and prognosis of all COVID-19&#xD;
      cases to be admitted in the assigned hospital with positive results of nasopharyngeal swab&#xD;
      for SARS-CoV-2 during one-month duration. According to our records, 30-60 patients may be&#xD;
      included.&#xD;
&#xD;
      Clinical Classification of COVID-19 patients according to the Egyptian Ministry of Health and&#xD;
      Population:&#xD;
&#xD;
        -  Mild Cases: The clinical symptoms are mild and no pneumonia manifestations can be found&#xD;
           in imaging.&#xD;
&#xD;
        -  Moderate Cases Patients have symptoms (such as fever and respiratory tract symptoms,&#xD;
           etc.) and pneumonia manifestations can be seen in imaging.&#xD;
&#xD;
        -  Severe Cases Adults who meet any of the following criteria: Respiratory rate&lt; 30&#xD;
           breaths/min; Oxygen saturations &lt; 93% at a rest state; Arterial partial pressure of&#xD;
           oxygen (PaO2)/Fraction of inspired oxygen (FiO2) [P/F ratio] &lt;300 mmHg; Patients with&#xD;
           more than 50% lesions progression within 24 to 48 hours in lung imaging should be&#xD;
           treated as severe cases.&#xD;
&#xD;
      Study Tools and Data Collection: All admitted patients to the hospital will be monitored&#xD;
      carefully and observed for medical treatment, supportive measures, hemodynamic variables, and&#xD;
      comorbid conditions.&#xD;
&#xD;
        -  Demographic Data: including age, sex and occupation.&#xD;
&#xD;
        -  History of travelling abroad and history of contact to confirmed cases (positive to&#xD;
           SARS-CoV-2).&#xD;
&#xD;
        -  Vital signs (heart rate, non-invasive blood pressure, respiratory rate, peripheral&#xD;
           oxygen saturation) at admission, at day 3, and day 7.&#xD;
&#xD;
        -  laboratory investigation:&#xD;
&#xD;
             -  Complete blood picture&#xD;
&#xD;
             -  CRP (C reactive protein)&#xD;
&#xD;
             -  Prothrombin time, concentration, and INR&#xD;
&#xD;
             -  Liver function (ALT, AST, bilirubin)&#xD;
&#xD;
             -  Kidney function (blood urea and serum creatinine)&#xD;
&#xD;
             -  Arterial blood gas (ABG): at admission, day1, day 3 and day 5.&#xD;
&#xD;
             -  D-Dimer and ferritin levels&#xD;
&#xD;
             -  HRCT chest (High resolution computed tomography) chest at admission and follow up&#xD;
                at discharge.&#xD;
&#xD;
        -  Follow up and outcome: (RT-PCR for SARS-CoV-2, CT chest, ABG).&#xD;
&#xD;
        -  The need of invasive mechanical ventilation, the clinical outcome, the duration of ICU&#xD;
           and hospital stay.&#xD;
&#xD;
        -  Any complications&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Actual">July 28, 2020</completion_date>
  <primary_completion_date type="Actual">July 28, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Prognosis Score</measure>
    <time_frame>1 month</time_frame>
    <description>The prognosis of COVID-19 patients at one quarantine hospital delivered to home, prolonged hospital stay, death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxygen Saturation</measure>
    <time_frame>14 days</time_frame>
    <description>Non-invasive peripheral oxygen saturation (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory Data</measure>
    <time_frame>14 days</time_frame>
    <description>Complete blood picture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological Features</measure>
    <time_frame>1 month</time_frame>
    <description>High resolution computed tomography chest at admission and follow up at discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Stay</measure>
    <time_frame>1 month</time_frame>
    <description>Duration of patients stay at hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver Function</measure>
    <time_frame>1 month</time_frame>
    <description>Complete liver function tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kidney Function</measure>
    <time_frame>1 month</time_frame>
    <description>Complete liver function tests</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">61</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>C Group</arm_group_label>
    <description>All COVID-19 cases to be admitted in the assigned hospital with positive results of nasopharyngeal swab for SARS-CoV-2 during one-month duration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prevalence of COVID-19</intervention_name>
    <description>All COVID-19 cases to be admitted in the assigned hospital with positive results of nasopharyngeal swab for SARS-CoV-2 during one-month duration.</description>
    <arm_group_label>C Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study is an investigator-initiated cross sectional trial to record, assess the&#xD;
        clinical manifestations and prognosis of all COVID-19 cases to be admitted in the assigned&#xD;
        hospital with positive results of nasopharyngeal swab for SARS-CoV-2 during one-month&#xD;
        duration.&#xD;
&#xD;
        The study aims To detect epidemiology, clinical and radiological presentation, laboratory&#xD;
        findings, complications, duration needed to conversion from positive to negative PCR,&#xD;
        duration of hospital stay and outcome of COVID-19 patients admitted in one quarantine&#xD;
        hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any Age&#xD;
&#xD;
          -  Any Sex&#xD;
&#xD;
          -  non pregnant women&#xD;
&#xD;
          -  RT-PCR positive for SARS-CoV-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient Refusal&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  patients stopped participation at anytime&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed F. Mostafa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>membership/educator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assiut University Hospitals</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>August 2, 2020</last_update_submitted>
  <last_update_submitted_qc>August 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohamed F. Mostafa</investigator_full_name>
    <investigator_title>Associate Professor of Anesthesia and Intensive Care</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>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/NCT04413045
org study id: Novel COVID-19 Prevalence
nct id: NCT04413045
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Pneumonia is a form of acute respiratory tract infection (ARTI) that affects the lungs. When
      an individual has pneumonia, the alveoli in the lungs are filled with pus and fluid, which
      makes breathing painful and limits oxygen intake. Pneumonia has many possible causes, but the
      most common are bacteria and viruses but nowadays there is a pandemic spread from novel
      corona virus which cause corona virus disease 2019 (COVID-19).

      Corona virus comprises of a large family of viruses that are common in human beings as well
      animals (camels, cattle, cats, and bats). There are seven different strains of corona virus.
      Sometimes corona virus from animals infect people and spread further via human to human
      transmission such as with MERS-CoV, SARS-CoV, and now with this COVID-19 (Corona disease
      2019). The virus that causes COVID-19 is designated as severe acute respiratory syndrome
      corona virus 2 (SARS-CoV-2); previously, referred to as 2019-nCoV.

      On Towards December 2019, this novel corona virus was identified as a cause of upper and
      lower respiratory tract infections in Wuhan, a city in the Hubei Province of China. It
      rapidly spread, resulting in an epidemic throughout China and then gradually spreading to
      other parts of the world in pandemic proportions. It has affected almost every continent in
      this world. In February 2020, the World Health Organization designated the disease COVID-19,
      which stands for corona virus disease 2019.

      The Coronaviruses are a large family of single-stranded RNA viruses (+ssRNA) that can be
      isolated in different animal species. They have a crown-like appearance under an electron
      microscope (coronam is the Latin term for crown) due to the presence of spike glycoproteins
      on the envelope. These viruses can also infect humans and cause illness ranging from the
      common cold to more severe diseases such as MERS, SARS and now COVID-19. According to recent
      research, a spike mutation, which probably occurred in late November 2019, triggered jumping
      to humans.
This study will be done at one quarantine hospital in Assiut, Egypt. After approval from our
      Institutional Ethics Committee, a written informed consent will be obtained from all patients
      or their legal representatives (if they are unable to provide consent) before enrollment in
      the study.

      Study Design and Sample Size Calculation: This study is an investigator-initiated cross
      sectional trial to record, assess the clinical manifestations and prognosis of all COVID-19
      cases to be admitted in the assigned hospital with positive results of nasopharyngeal swab
      for SARS-CoV-2 during one-month duration. According to our records, 30-60 patients may be
      included.

      Clinical Classification of COVID-19 patients according to the Egyptian Ministry of Health and
      Population:

        -  Mild Cases: The clinical symptoms are mild and no pneumonia manifestations can be found
           in imaging.

        -  Moderate Cases Patients have symptoms (such as fever and respiratory tract symptoms,
           etc.) and pneumonia manifestations can be seen in imaging.

        -  Severe Cases Adults who meet any of the following criteria: Respiratory rate< 30
           breaths/min; Oxygen saturations < 93% at a rest state; Arterial partial pressure of
           oxygen (PaO2)/Fraction of inspired oxygen (FiO2) [P/F ratio] <300 mmHg; Patients with
           more than 50% lesions progression within 24 to 48 hours in lung imaging should be
           treated as severe cases.

      Study Tools and Data Collection: All admitted patients to the hospital will be monitored
      carefully and observed for medical treatment, supportive measures, hemodynamic variables, and
      comorbid conditions.

        -  Demographic Data: including age, sex and occupation.

        -  History of travelling abroad and history of contact to confirmed cases (positive to
           SARS-CoV-2).

        -  Vital signs (heart rate, non-invasive blood pressure, respiratory rate, peripheral
           oxygen saturation) at admission, at day 3, and day 7.

        -  laboratory investigation:

             -  Complete blood picture

             -  CRP (C reactive protein)

             -  Prothrombin time, concentration, and INR

             -  Liver function (ALT, AST, bilirubin)

             -  Kidney function (blood urea and serum creatinine)

             -  Arterial blood gas (ABG): at admission, day1, day 3 and day 5.

             -  D-Dimer and ferritin levels

             -  HRCT chest (High resolution computed tomography) chest at admission and follow up
                at discharge.

        -  Follow up and outcome: (RT-PCR for SARS-CoV-2, CT chest, ABG).

        -  The need of invasive mechanical ventilation, the clinical outcome, the duration of ICU
           and hospital stay.

        -  Any complications
observational model: Other
time perspective: Retrospective
measure: Patient Prognosis Score
time frame: 1 month
description: The prognosis of COVID-19 patients at one quarantine hospital delivered to home, prolonged hospital stay, death.
measure: Oxygen Saturation
time frame: 14 days
description: Non-invasive peripheral oxygen saturation (%)
measure: Laboratory Data
time frame: 14 days
description: Complete blood picture
measure: Radiological Features
time frame: 1 month
description: High resolution computed tomography chest at admission and follow up at discharge
measure: Hospital Stay
time frame: 1 month
description: Duration of patients stay at hospital
measure: Liver Function
time frame: 1 month
description: Complete liver function tests
measure: Kidney Function
time frame: 1 month
description: Complete liver function tests
arm group label: C Group
description: All COVID-19 cases to be admitted in the assigned hospital with positive results of nasopharyngeal swab for SARS-CoV-2 during one-month duration.
intervention type: Other
intervention name: Prevalence of COVID-19
description: All COVID-19 cases to be admitted in the assigned hospital with positive results of nasopharyngeal swab for SARS-CoV-2 during one-month duration.
arm group label: C Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Mohamed F. Mostafa, MD
role: Principal Investigator
affiliation: membership/educator
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohamed F. Mostafa
investigator title: Associate Professor of Anesthesia and Intensive Care
mesh term: COVID-19
sharing ipd: Undecided