<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/NCT04427345</url>
  </required_header>
  <id_info>
    <org_study_id>MI-COVID</org_study_id>
    <nct_id>NCT04427345</nct_id>
  </id_info>
  <brief_title>Predictive Factors COVID-19 Patients</brief_title>
  <acronym>MI-COVID</acronym>
  <official_title>Predictive Clinical Response Factors in COVID-19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Milano Bicocca</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Milano Bicocca</source>
  <oversight_info>
    <has_dmc>Yes</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 is a monocentric retro-prospective observational study that will be conducted on all&#xD;
      COVID19 positive patients hospitalized at the S. Gerardo Hospital in Monza.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND:&#xD;
&#xD;
      The Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) pandemic is severely testing&#xD;
      the health systems of the most advanced countries. Clinicians are faced with a new pathology&#xD;
      of an emerging virus. There is therefore an urgent need to collect real-time clinical data&#xD;
      that informs about outcome predictive variables. Furthermore, there are currently no&#xD;
      antiviral drugs approved for the treatment of SARS-CoV-2 infection, off-label therapies are&#xD;
      being used with drugs already in use for other pathologies that have shown some efficacy in&#xD;
      vitro, and some treatments obtained for compassionate use with other drugs that are being&#xD;
      tested.&#xD;
&#xD;
      It is more than ever necessary to collect clinical practice data both retrospectively on the&#xD;
      work done so far, and in a longitudinal perspective, and analyze them quickly to optimize&#xD;
      current treatments and define protocols for the future. Having a good clinical data base also&#xD;
      offers the possibility of collaborating with numerous international networks on translational&#xD;
      research, which aims to correlate clinical data with virological and immunological data,&#xD;
      aimed at the rapid identification of possible specific viral virulence factors, or particular&#xD;
      immune structures of the guests who once again define the final clinical outcome.&#xD;
&#xD;
      STUDY DESIGN:&#xD;
&#xD;
      All COVID19 positive patients admitted to San Gerardo Hospital will be enrolled in the study.&#xD;
&#xD;
      After patient signs the informed consent, the following data will be collected:&#xD;
&#xD;
        -  birth data&#xD;
&#xD;
        -  sex&#xD;
&#xD;
        -  demographic data&#xD;
&#xD;
        -  comorbidity&#xD;
&#xD;
        -  blood chemistry data at the entrance&#xD;
&#xD;
      A series of variables will then be collected relating to the treatment procedure, the&#xD;
      therapies, the team's choice to maximize the care ceiling in the individual patient and the&#xD;
      entire clinical study of the patient.&#xD;
&#xD;
      STATISTICAL ANALISYS:&#xD;
&#xD;
      Central tendency and dispersion measurements will be used for descriptive analysis of&#xD;
      continuous variables while absolute and relative frequencies will be used to describe&#xD;
      categorical variables.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    This study has been included in another trial within the same Sponsor&#xD;
  </why_stopped>
  <start_date type="Actual">April 30, 2020</start_date>
  <completion_date type="Actual">May 12, 2022</completion_date>
  <primary_completion_date type="Anticipated">May 2021</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identify risk factors for intra-hospital mortality.</measure>
    <time_frame>Until patient discharge from the hospital (approximately 1 year)</time_frame>
    <description>Identify risk factors for intra-hospital mortality in patients admitted to the COVID + hospital wards of San Gerardo hospital.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identify risk factors to build a prognostic score.</measure>
    <time_frame>Until patient discharge from the hospital (approximately 1 year)</time_frame>
    <description>Identify the risk factors to build a prognostic score through which it is possible to define a stratification that immediately guides the therapeutic choices.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identify risk factors to build a prognostic score.</measure>
    <time_frame>Until patient discharge from the hospital (approximately 1 year)</time_frame>
    <description>Identify the risk factors to build a prognostic score through which it is possible to define a stratification that immediately directs towards the right intensity of care.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Predictive factors for the hospitalization duration.</measure>
    <time_frame>Until patient discharge from the hospital (approximately 1 year)</time_frame>
    <description>Description of the predictive factors for the hospitalization duration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Predictive factors for clinical status patients based on &quot;Ordinal Scale for Clinical Improvement&quot;</measure>
    <time_frame>Until patient discharge from the hospital (approximately 1 year)</time_frame>
    <description>Description of the predictive factors for the clinical status of patients based on &quot;Ordinal Scale for Clinical Improvement&quot; defined by OMS (</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Describe the anti-viral therapies used commonly in this emergency in terms of efficacy</measure>
    <time_frame>Until patient discharge from the hospital (approximately 1 year).</time_frame>
    <description>Description of efficacy of the anti-viral therapies used today without particular restrictions, but on which solid clinical functioning tests are lacking.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Describe the anti-viral therapies used commonly used in this emergency in terms of safety</measure>
    <time_frame>Until patient discharge from the hospital (approximately 1 year).</time_frame>
    <description>Description of safety of the anti-viral therapies used today without particular restrictions, but on which solid clinical functioning tests are lacking.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Monitor the clinical course of the disease in discharged patients.</measure>
    <time_frame>12 month after discharge</time_frame>
    <description>Description of the disease clinical course in patients 12 months after discharge (mortality, neurological, respiratory and cardiac outcomes).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>covid19</condition>
  <arm_group>
    <arm_group_label>Covid19 infection related patients</arm_group_label>
    <description>Patients admitted to COVID wards of the S. Gerardo Hospital of Monza, including Intensive Care wards.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Predictive factors for clinical response in patients with COVID-19.</intervention_name>
    <description>Identify the risk factors for intra-hospital mortality in patients hospitalized in the COVID + hospital wards of the San Gerardo hospital and build a prognostic score through which it is possible to define a stratification that immediately guides the therapeutic choices and the intensity of care .</description>
    <arm_group_label>Covid19 infection related patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study involves patients admitted to San Gerardo Hospital from March 1, 2020 to May 31,&#xD;
        2020. The minimum expected follow-up will be one year for all patients.&#xD;
&#xD;
        Given the nature of the study, no formal calculation of the sample size was made, nor was a&#xD;
        sample size predefined. However, given the recruiting potential of the center which in&#xD;
        March saw on average 30-60 hospitalizations due to SARS-CoV-2 per day, even considering a&#xD;
        progressive decrease in access, it is assumed that the proportion of patients who will be&#xD;
        included in the study will exceed 1000 units.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 18 years old or above&#xD;
&#xD;
          -  Diagnosis of SARS-CoV-2 pneumonia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Explicit refusal to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ASST Monza-Ospedale San Gerardo</name>
      <address>
        <city>Monza</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Rosenbaum L. Facing Covid-19 in Italy - Ethics, Logistics, and Therapeutics on the Epidemic's Front Line. N Engl J Med. 2020 May 14;382(20):1873-1875. doi: 10.1056/NEJMp2005492. Epub 2020 Mar 18. No abstract available.</citation>
    <PMID>32187459</PMID>
  </reference>
  <reference>
    <citation>Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.</citation>
    <PMID>32007143</PMID>
  </reference>
  <reference>
    <citation>Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.</citation>
    <PMID>32031570</PMID>
  </reference>
  <reference>
    <citation>Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994. Erratum In: JAMA Intern Med. 2020 Jul 1;180(7):1031.</citation>
    <PMID>32167524</PMID>
  </reference>
  <reference>
    <citation>Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.</citation>
    <PMID>32091533</PMID>
  </reference>
  <reference>
    <citation>Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.</citation>
    <PMID>32109013</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>May 19, 2022</last_update_submitted>
  <last_update_submitted_qc>May 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronavirus</keyword>
  <keyword>sars-covid-2</keyword>
  <keyword>coronavirus infection</keyword>
  <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/NCT04427345
org study id: MI-COVID
nct id: NCT04427345
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a monocentric retro-prospective observational study that will be conducted on all
      COVID19 positive patients hospitalized at the S. Gerardo Hospital in Monza.
BACKGROUND:

      The Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) pandemic is severely testing
      the health systems of the most advanced countries. Clinicians are faced with a new pathology
      of an emerging virus. There is therefore an urgent need to collect real-time clinical data
      that informs about outcome predictive variables. Furthermore, there are currently no
      antiviral drugs approved for the treatment of SARS-CoV-2 infection, off-label therapies are
      being used with drugs already in use for other pathologies that have shown some efficacy in
      vitro, and some treatments obtained for compassionate use with other drugs that are being
      tested.

      It is more than ever necessary to collect clinical practice data both retrospectively on the
      work done so far, and in a longitudinal perspective, and analyze them quickly to optimize
      current treatments and define protocols for the future. Having a good clinical data base also
      offers the possibility of collaborating with numerous international networks on translational
      research, which aims to correlate clinical data with virological and immunological data,
      aimed at the rapid identification of possible specific viral virulence factors, or particular
      immune structures of the guests who once again define the final clinical outcome.

      STUDY DESIGN:

      All COVID19 positive patients admitted to San Gerardo Hospital will be enrolled in the study.

      After patient signs the informed consent, the following data will be collected:

        -  birth data

        -  sex

        -  demographic data

        -  comorbidity

        -  blood chemistry data at the entrance

      A series of variables will then be collected relating to the treatment procedure, the
      therapies, the team's choice to maximize the care ceiling in the individual patient and the
      entire clinical study of the patient.

      STATISTICAL ANALISYS:

      Central tendency and dispersion measurements will be used for descriptive analysis of
      continuous variables while absolute and relative frequencies will be used to describe
      categorical variables.
observational model: Cohort
time perspective: Retrospective
measure: Identify risk factors for intra-hospital mortality.
time frame: Until patient discharge from the hospital (approximately 1 year)
description: Identify risk factors for intra-hospital mortality in patients admitted to the COVID + hospital wards of San Gerardo hospital.
measure: Identify risk factors to build a prognostic score.
time frame: Until patient discharge from the hospital (approximately 1 year)
description: Identify the risk factors to build a prognostic score through which it is possible to define a stratification that immediately guides the therapeutic choices.
measure: Identify risk factors to build a prognostic score.
time frame: Until patient discharge from the hospital (approximately 1 year)
description: Identify the risk factors to build a prognostic score through which it is possible to define a stratification that immediately directs towards the right intensity of care.
measure: Predictive factors for the hospitalization duration.
time frame: Until patient discharge from the hospital (approximately 1 year)
description: Description of the predictive factors for the hospitalization duration.
measure: Predictive factors for clinical status patients based on "Ordinal Scale for Clinical Improvement"
time frame: Until patient discharge from the hospital (approximately 1 year)
description: Description of the predictive factors for the clinical status of patients based on "Ordinal Scale for Clinical Improvement" defined by OMS (
measure: Describe the anti-viral therapies used commonly in this emergency in terms of efficacy
time frame: Until patient discharge from the hospital (approximately 1 year).
description: Description of efficacy of the anti-viral therapies used today without particular restrictions, but on which solid clinical functioning tests are lacking.
measure: Describe the anti-viral therapies used commonly used in this emergency in terms of safety
time frame: Until patient discharge from the hospital (approximately 1 year).
description: Description of safety of the anti-viral therapies used today without particular restrictions, but on which solid clinical functioning tests are lacking.
measure: Monitor the clinical course of the disease in discharged patients.
time frame: 12 month after discharge
description: Description of the disease clinical course in patients 12 months after discharge (mortality, neurological, respiratory and cardiac outcomes).
arm group label: Covid19 infection related patients
description: Patients admitted to COVID wards of the S. Gerardo Hospital of Monza, including Intensive Care wards.
intervention type: Other
intervention name: Predictive factors for clinical response in patients with COVID-19.
description: Identify the risk factors for intra-hospital mortality in patients hospitalized in the COVID + hospital wards of the San Gerardo hospital and build a prognostic score through which it is possible to define a stratification that immediately guides the therapeutic choices and the intensity of care .
arm group label: Covid19 infection related patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
citation: Rosenbaum L. Facing Covid-19 in Italy - Ethics, Logistics, and Therapeutics on the Epidemic's Front Line. N Engl J Med. 2020 May 14;382(20):1873-1875. doi: 10.1056/NEJMp2005492. Epub 2020 Mar 18. No abstract available.
PMID: 32187459
citation: Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
PMID: 32007143
citation: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.
PMID: 32031570
citation: Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994. Erratum In: JAMA Intern Med. 2020 Jul 1;180(7):1031.
PMID: 32167524
citation: Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
PMID: 32091533
citation: Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PMID: 32109013
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No