<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/NCT04454372</url>
  </required_header>
  <id_info>
    <org_study_id>covid-19 ICU</org_study_id>
    <nct_id>NCT04454372</nct_id>
  </id_info>
  <brief_title>Clinical Characteristics and Outcomes of 187 Critically Ill Patients With Coronavirus Disease 2019 (COVID-19)</brief_title>
  <official_title>Clinical Characteristics and Outcomes of 187 Critically Ill Patients With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Sao Domingos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Sao Domingos</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 case series describes the clinical characteristics, treatment and outcomes of patients&#xD;
      with laboratory confirmed COVID-19 admitted to a 35 beds intensive care unit of a tertiary&#xD;
      hospital in Northeast Brazil.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This retrospective observational study will be carried out at Hospital São Domingos, state of&#xD;
      Maranhao, Brasil. It is a tertiary hospital with 450 beds and six Intensive Care Units (ICU)&#xD;
      with a total of 63 beds. With the admission of the first patients with Coronavirus Disease&#xD;
      2019 (COVID-19) as of March 20, we initially made available a 12 beds ICU exclusively for the&#xD;
      treatment of patients with COVID-19. At the beginning of April, the number of beds was&#xD;
      increased to 35 and, immediately afterwards, two semi-intensive units (16 and 21 beds) were&#xD;
      created for patients in need of non-invasive respiratory support, with the 35 beds ICU 35&#xD;
      dedicated to receive only patients in need of high-level support (usually invasive mechanical&#xD;
      ventilation) with or without other organ dysfunctions.&#xD;
&#xD;
      In the period from March 20 to June 15, 2020, 935 patients with confirmed diagnosis (RT-PCR)&#xD;
      of COVID-19 were admitted to the hospital and 187 of them were treated in the ICU.&#xD;
&#xD;
      Data were obtained from the hospital's electronic medical record. Demographic and severity&#xD;
      data included age, sex, Simplified Acute Physiology 3 (SAPS 3) and Sequential Organ Failure&#xD;
      Assessment (SOFA) scores at admission, nutritional risk determined by Nutritional Risk&#xD;
      Screening 2002 (NRS-2002) and commodities. Clinical and laboratory data on arrival at the ICU&#xD;
      including Partial pressure of oxygen in arterial bood / Inspired fraction of oxygen (PaO2 /&#xD;
      FIO2) complete blood count and PCR D-dimer, ferritin, fibrinogen and lactic acid&#xD;
      dehydrogenasew (LDH). Drug interventions including use of hydroxychloroquine,&#xD;
      corticosteroids, heparin, tocilizumab. Characteristics of invasive and non-invasive&#xD;
      respiratory support, use of prone position, ECMO and vasoactive drugs. The main&#xD;
      complications, acute kidney injury requiring hemodialysis, secondary infectious complications&#xD;
      will be documented as well as the outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 20, 2020</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>Outcome 30 days after ICU admission</measure>
    <time_frame>30 days after admission</time_frame>
    <description>A seven-category ordinal scale consisting of: 1. Death; 2. hospitalized, on invasive mechanical ventilation; 3. hospitalized, on non-invasive ventilation; 4. hospitalized, requiring supplemental oxygen; 5. hospitalized not requiring supplemental oxygen; 6. hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care. 7 Not hospitalized</description>
  </primary_outcome>
  <enrollment type="Actual">187</enrollment>
  <condition>COVID-19</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>demographic and clinical data obtained from hospital's electronic medical record.</intervention_name>
    <description>This retrospective observational study. . Demographic and severity data will include age, sex, SAPS 3 and SOFA scores at admission, nutritional risk determined by NRS-2002 and commodities. Clinical and laboratory data on arrival at the ICU including PaO2 / FIO2, blood count and PCR D-dimer, ferritin, fibrinogen, DHL. Drug interventions including use of hydroxychloroquine, corticosteroids, heparin, tocilizumab. Characteristics of invasive and non-invasive respiratory support, use of prone position and ECMO and vasoactive drugs. The main complications, acute kidney injury requiring renal replacement therapy, secondary infectious complications will be documented as well as the outcomes.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All critically ill patients admitted to the 35 beds ICU dedicated to COVID-19 in the period&#xD;
        of March 20 and June 15, 2020 with laboratory confirmed diagnosis of COVID-19. Patients&#xD;
        that could be managed without invasive mechanical ventilation and that did not require&#xD;
        other high level life support were managed in one of the semi intensive units (16 and 21&#xD;
        beds).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients admitted to the 35 beds ICU between March 20 and June 15, 2020 with&#xD;
             laboratory confirmed diagnosis of COVID-19 (RT-PCR).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients admitted to the ICU in which the RT-PCR was negative, and patients that did&#xD;
             not require high level life support (RRT, Prone position, ECMO, hemodymnamic&#xD;
             monitoring and support).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JOSE AZEVEDO, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Sao Domingos</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Sao Domingos</name>
      <address>
        <city>Sao Luis</city>
        <state>MA</state>
        <zip>65060-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Yang P, Tekwani S, Martin GS. In COVID-19, adding lopinavir-ritonavir to usual care did not shorten time to clinical improvement. Ann Intern Med. 2020 Jun 16;172(12):JC63. doi: 10.7326/ACPJ202006160-063.</citation>
    <PMID>32539520</PMID>
  </reference>
  <reference>
    <citation>Grein J, Ohmagari N, Shin D, Diaz G, Asperges E, Castagna A, Feldt T, Green G, Green ML, Lescure FX, Nicastri E, Oda R, Yo K, Quiros-Roldan E, Studemeister A, Redinski J, Ahmed S, Bernett J, Chelliah D, Chen D, Chihara S, Cohen SH, Cunningham J, D'Arminio Monforte A, Ismail S, Kato H, Lapadula G, L'Her E, Maeno T, Majumder S, Massari M, Mora-Rillo M, Mutoh Y, Nguyen D, Verweij E, Zoufaly A, Osinusi AO, DeZure A, Zhao Y, Zhong L, Chokkalingam A, Elboudwarej E, Telep L, Timbs L, Henne I, Sellers S, Cao H, Tan SK, Winterbourne L, Desai P, Mera R, Gaggar A, Myers RP, Brainard DM, Childs R, Flanigan T. Compassionate Use of Remdesivir for Patients with Severe Covid-19. N Engl J Med. 2020 Jun 11;382(24):2327-2336. doi: 10.1056/NEJMoa2007016. Epub 2020 Apr 10.</citation>
    <PMID>32275812</PMID>
  </reference>
  <reference>
    <citation>Alhazzani W, Moller MH, Arabi YM, Loeb M, Gong MN, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Aboodi M, Wunsch H, Cecconi M, Koh Y, Chertow DS, Maitland K, Alshamsi F, Belley-Cote E, Greco M, Laundy M, Morgan JS, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Alexander PE, Arrington A, Centofanti JE, Citerio G, Baw B, Memish ZA, Hammond N, Hayden FG, Evans L, Rhodes A. Surviving Sepsis Campaign: guidelines on the management of critically ill adults with Coronavirus Disease 2019 (COVID-19). Intensive Care Med. 2020 May;46(5):854-887. doi: 10.1007/s00134-020-06022-5. Epub 2020 Mar 28.</citation>
    <PMID>32222812</PMID>
  </reference>
  <results_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>
  </results_reference>
  <results_reference>
    <citation>Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775. Erratum In: JAMA. 2020 May 26;323(20):2098.</citation>
    <PMID>32320003</PMID>
  </results_reference>
  <results_reference>
    <citation>Zhang C, Wu Z, Li JW, Zhao H, Wang GQ. Cytokine release syndrome in severe COVID-19: interleukin-6 receptor antagonist tocilizumab may be the key to reduce mortality. Int J Antimicrob Agents. 2020 May;55(5):105954. doi: 10.1016/j.ijantimicag.2020.105954. Epub 2020 Mar 29.</citation>
    <PMID>32234467</PMID>
  </results_reference>
  <results_reference>
    <citation>Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.</citation>
    <PMID>32192578</PMID>
  </results_reference>
  <results_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>
  </results_reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>March 14, 2022</last_update_submitted>
  <last_update_submitted_qc>March 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Sao Domingos</investigator_affiliation>
    <investigator_full_name>José Raimundo Araujo de Azevedo</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>critically ill patients</keyword>
  <keyword>outcomes</keyword>
  <keyword>treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Critical Illness</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/NCT04454372
org study id: covid-19 ICU
nct id: NCT04454372
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This case series describes the clinical characteristics, treatment and outcomes of patients
      with laboratory confirmed COVID-19 admitted to a 35 beds intensive care unit of a tertiary
      hospital in Northeast Brazil.
This retrospective observational study will be carried out at Hospital São Domingos, state of
      Maranhao, Brasil. It is a tertiary hospital with 450 beds and six Intensive Care Units (ICU)
      with a total of 63 beds. With the admission of the first patients with Coronavirus Disease
      2019 (COVID-19) as of March 20, we initially made available a 12 beds ICU exclusively for the
      treatment of patients with COVID-19. At the beginning of April, the number of beds was
      increased to 35 and, immediately afterwards, two semi-intensive units (16 and 21 beds) were
      created for patients in need of non-invasive respiratory support, with the 35 beds ICU 35
      dedicated to receive only patients in need of high-level support (usually invasive mechanical
      ventilation) with or without other organ dysfunctions.

      In the period from March 20 to June 15, 2020, 935 patients with confirmed diagnosis (RT-PCR)
      of COVID-19 were admitted to the hospital and 187 of them were treated in the ICU.

      Data were obtained from the hospital's electronic medical record. Demographic and severity
      data included age, sex, Simplified Acute Physiology 3 (SAPS 3) and Sequential Organ Failure
      Assessment (SOFA) scores at admission, nutritional risk determined by Nutritional Risk
      Screening 2002 (NRS-2002) and commodities. Clinical and laboratory data on arrival at the ICU
      including Partial pressure of oxygen in arterial bood / Inspired fraction of oxygen (PaO2 /
      FIO2) complete blood count and PCR D-dimer, ferritin, fibrinogen and lactic acid
      dehydrogenasew (LDH). Drug interventions including use of hydroxychloroquine,
      corticosteroids, heparin, tocilizumab. Characteristics of invasive and non-invasive
      respiratory support, use of prone position, ECMO and vasoactive drugs. The main
      complications, acute kidney injury requiring hemodialysis, secondary infectious complications
      will be documented as well as the outcomes.
observational model: Cohort
time perspective: Retrospective
measure: Outcome 30 days after ICU admission
time frame: 30 days after admission
description: A seven-category ordinal scale consisting of: 1. Death; 2. hospitalized, on invasive mechanical ventilation; 3. hospitalized, on non-invasive ventilation; 4. hospitalized, requiring supplemental oxygen; 5. hospitalized not requiring supplemental oxygen; 6. hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care. 7 Not hospitalized
intervention type: Other
intervention name: demographic and clinical data obtained from hospital's electronic medical record.
description: This retrospective observational study. . Demographic and severity data will include age, sex, SAPS 3 and SOFA scores at admission, nutritional risk determined by NRS-2002 and commodities. Clinical and laboratory data on arrival at the ICU including PaO2 / FIO2, blood count and PCR D-dimer, ferritin, fibrinogen, DHL. Drug interventions including use of hydroxychloroquine, corticosteroids, heparin, tocilizumab. Characteristics of invasive and non-invasive respiratory support, use of prone position and ECMO and vasoactive drugs. The main complications, acute kidney injury requiring renal replacement therapy, secondary infectious complications will be documented as well as the outcomes.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: No
last name: JOSE AZEVEDO, MD
role: Study Chair
affiliation: Hospital Sao Domingos
facility: 
country: Brazil
citation: Yang P, Tekwani S, Martin GS. In COVID-19, adding lopinavir-ritonavir to usual care did not shorten time to clinical improvement. Ann Intern Med. 2020 Jun 16;172(12):JC63. doi: 10.7326/ACPJ202006160-063.
PMID: 32539520
citation: Grein J, Ohmagari N, Shin D, Diaz G, Asperges E, Castagna A, Feldt T, Green G, Green ML, Lescure FX, Nicastri E, Oda R, Yo K, Quiros-Roldan E, Studemeister A, Redinski J, Ahmed S, Bernett J, Chelliah D, Chen D, Chihara S, Cohen SH, Cunningham J, D'Arminio Monforte A, Ismail S, Kato H, Lapadula G, L'Her E, Maeno T, Majumder S, Massari M, Mora-Rillo M, Mutoh Y, Nguyen D, Verweij E, Zoufaly A, Osinusi AO, DeZure A, Zhao Y, Zhong L, Chokkalingam A, Elboudwarej E, Telep L, Timbs L, Henne I, Sellers S, Cao H, Tan SK, Winterbourne L, Desai P, Mera R, Gaggar A, Myers RP, Brainard DM, Childs R, Flanigan T. Compassionate Use of Remdesivir for Patients with Severe Covid-19. N Engl J Med. 2020 Jun 11;382(24):2327-2336. doi: 10.1056/NEJMoa2007016. Epub 2020 Apr 10.
PMID: 32275812
citation: Alhazzani W, Moller MH, Arabi YM, Loeb M, Gong MN, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Aboodi M, Wunsch H, Cecconi M, Koh Y, Chertow DS, Maitland K, Alshamsi F, Belley-Cote E, Greco M, Laundy M, Morgan JS, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Alexander PE, Arrington A, Centofanti JE, Citerio G, Baw B, Memish ZA, Hammond N, Hayden FG, Evans L, Rhodes A. Surviving Sepsis Campaign: guidelines on the management of critically ill adults with Coronavirus Disease 2019 (COVID-19). Intensive Care Med. 2020 May;46(5):854-887. doi: 10.1007/s00134-020-06022-5. Epub 2020 Mar 28.
PMID: 32222812
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
citation: Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775. Erratum In: JAMA. 2020 May 26;323(20):2098.
PMID: 32320003
citation: Zhang C, Wu Z, Li JW, Zhao H, Wang GQ. Cytokine release syndrome in severe COVID-19: interleukin-6 receptor antagonist tocilizumab may be the key to reduce mortality. Int J Antimicrob Agents. 2020 May;55(5):105954. doi: 10.1016/j.ijantimicag.2020.105954. Epub 2020 Mar 29.
PMID: 32234467
citation: Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.
PMID: 32192578
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
responsible party type: Principal Investigator
investigator affiliation: Hospital Sao Domingos
investigator full name: José Raimundo Araujo de Azevedo
investigator title: Principal investigator
mesh term: COVID-19
mesh term: Critical Illness
sharing ipd: No