<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/NCT04412746</url>
  </required_header>
  <id_info>
    <org_study_id>COVIDIAB-13</org_study_id>
    <nct_id>NCT04412746</nct_id>
  </id_info>
  <brief_title>Covid-19 and Diabetes in West of Algeria</brief_title>
  <acronym>COVIDIAB-13</acronym>
  <official_title>Prevalence of Diabetes Among Hospitalized Patients With Covid-19 in West of Algeria. Identification of Diabetes-related Associated Factors Severe Forms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laboratoire De Recherche Sur Le Diabete, Université de Tlemcen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ATRSS, DGRST, Algeria</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Laboratoire De Recherche Sur Le Diabete, Université de Tlemcen</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>
      By Jan 7, 2020, Chinese scientists had isolated a novel coronavirus, from patients with&#xD;
      virus-infected pneumonia. The WHO designated later this virus as COVID-19 (coronavirus&#xD;
      disease 2019). This exponential pandemic coronavirus infection is responsible for severe&#xD;
      forms in 15 to 20%, for critical ill requiring ventilation in 5% and for mortality in 2%.&#xD;
      Algeria was part of the 13 top priority countries identified by WHO based on their direct&#xD;
      links and volume of travel to the infected provinces in China.&#xD;
&#xD;
      It is known that some predisposing conditions lead to a worse outcome with coronavirus.&#xD;
&#xD;
      In China, the overall case-fatality rate was 2.3%, but was higher in patients with diabetes&#xD;
      (7.3%). In Italy, the most common comorbidities associated with death from COVID-19 were&#xD;
      hypertension (73.8%) and diabetes (33.9%). The US Centers for Disease Control and Prevention&#xD;
      suggests diabetes is the most common comorbidity in COVID-19 cases. In the largest cohort NHS&#xD;
      England study, death from COVID-19 was strongly associated with uncontrolled diabetes (after&#xD;
      full adjustment, HR 2.36).&#xD;
&#xD;
      The West Algerian CORODIAB-13 study aims is (1) to assess the prevalence of diabetes among&#xD;
      hospitalized patients with Covid-19, (2) to describe the phenotypic characteristics of&#xD;
      patients with diabetes, and (3) to identify the parameters specific to the diabetic which are&#xD;
      associated with severe forms.&#xD;
&#xD;
      In the future, this study will provide answers for two main questions&#xD;
&#xD;
        1. Why diabetics are more at risk of developing Covid-19 infection?&#xD;
&#xD;
        2. Why diabetics are at high risk of developing severe forms?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 30, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of diabetes among all hospitalized COVID-19</measure>
    <time_frame>3 months</time_frame>
    <description>Assess the prevalence of diabetes among hospitalized patients with Covid-19 in Area of Tlemcen</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diabetes-related factors risk</measure>
    <time_frame>3 months</time_frame>
    <description>Describe the clinical and biological characteristics of hospitalized subjects with diabetes and COVID-19</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Coronavirus Infections</condition>
  <condition>Diabetes Mellitus</condition>
  <condition>Prevalence</condition>
  <condition>Risk Factors</condition>
  <condition>Patient Outcome Assessment</condition>
  <condition>Severe Acute Respiratory Syndrome</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MANAGEMENT OF COVID-19</intervention_name>
    <description>MANAGEMENT OF COVID-19 Oxygen therapy to maintain SpO2 target more than 94%. Low molecular weight heparin (LMWH) at preventive doses. Empirical antibiotic treatment.&#xD;
Specific treatment for COVID-19 (approved by Algerian Ministry of Health) First line: Hydroxychloroquin: 200 mg oral three times a day for 10 days, with association of Azithromycin 250 mg oral : 500 mg the first day and 250 mg once a day for 4 days. Sulfate de Zinc : 220 mg once a day for 5 days. Second line: Lopinavir/ritonavir capsule 200 mg/50 mg, oral 2 capsules each times, twice a day during 5 to 7 days.&#xD;
IF AGGRAVATION OR CRITICAL ILL CONDITION AT PRESENTATION Increase oxygenation flow. Consider Glucocorticoids. 3. Consider the diagnosis of pulmonary embolism and treat with LMWH at therapeutic doses.&#xD;
MANAGEMENT OF DIABETES Discontinue metformin. Start or adjust insulin doses according to personalized glycemic target of patient.</description>
    <other_name>MANAGEMENT OF DIABETES</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults diabetic patients with COVID-19 infection admitted in academic hospital of Tlemcen&#xD;
        (Algeria).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted in a hospital center since 1th April 2020&#xD;
&#xD;
          -  Patients with COVID19 with biological proof (specific PCR) or with clinical and&#xD;
             radiological diagnosis.&#xD;
&#xD;
          -  Patient with diabetes known before the admission&#xD;
&#xD;
          -  New onset diabetes discovered at admission (plasma glycaemia value strictly greater&#xD;
             than 2 g/l at any time)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Active Cancer&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Minors, adults under guardianship, protected persons&#xD;
&#xD;
          -  Significant disability (The Modified Rankin Scale more than 2 prior admission)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Internal Medicine, Acedemic Hospital of Tlemcen</name>
      <address>
        <city>Tlemcen</city>
        <zip>130000</zip>
        <country>Algeria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ALI LOUNICI, Professor</last_name>
      <phone>00213667314275</phone>
      <email>ali.lounici@univ-tlemcen.dz</email>
    </contact>
    <investigator>
      <last_name>Benattou ZIANE, Professor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Samia BENCHOUK, Professor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Algeria</country>
  </location_countries>
  <verification_date>June 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>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Laboratoire De Recherche Sur Le Diabete, Université de Tlemcen</investigator_affiliation>
    <investigator_full_name>ALI LOUNICI</investigator_full_name>
    <investigator_title>Chief of Internal Medicine Department</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>DIABETES</keyword>
  <keyword>RISK FACTORS</keyword>
  <keyword>SEVERE ILLNESS</keyword>
  <keyword>OUTCOMES</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Severe Acute Respiratory Syndrome</mesh_term>
    <mesh_term>Diabetes Mellitus</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/NCT04412746
org study id: COVIDIAB-13
nct id: NCT04412746
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
By Jan 7, 2020, Chinese scientists had isolated a novel coronavirus, from patients with
      virus-infected pneumonia. The WHO designated later this virus as COVID-19 (coronavirus
      disease 2019). This exponential pandemic coronavirus infection is responsible for severe
      forms in 15 to 20%, for critical ill requiring ventilation in 5% and for mortality in 2%.
      Algeria was part of the 13 top priority countries identified by WHO based on their direct
      links and volume of travel to the infected provinces in China.

      It is known that some predisposing conditions lead to a worse outcome with coronavirus.

      In China, the overall case-fatality rate was 2.3%, but was higher in patients with diabetes
      (7.3%). In Italy, the most common comorbidities associated with death from COVID-19 were
      hypertension (73.8%) and diabetes (33.9%). The US Centers for Disease Control and Prevention
      suggests diabetes is the most common comorbidity in COVID-19 cases. In the largest cohort NHS
      England study, death from COVID-19 was strongly associated with uncontrolled diabetes (after
      full adjustment, HR 2.36).

      The West Algerian CORODIAB-13 study aims is (1) to assess the prevalence of diabetes among
      hospitalized patients with Covid-19, (2) to describe the phenotypic characteristics of
      patients with diabetes, and (3) to identify the parameters specific to the diabetic which are
      associated with severe forms.

      In the future, this study will provide answers for two main questions

        1. Why diabetics are more at risk of developing Covid-19 infection?

        2. Why diabetics are at high risk of developing severe forms?
observational model: Cohort
time perspective: Prospective
measure: Prevalence of diabetes among all hospitalized COVID-19
time frame: 3 months
description: Assess the prevalence of diabetes among hospitalized patients with Covid-19 in Area of Tlemcen
measure: Diabetes-related factors risk
time frame: 3 months
description: Describe the clinical and biological characteristics of hospitalized subjects with diabetes and COVID-19
intervention type: Drug
intervention name: MANAGEMENT OF COVID-19
description: MANAGEMENT OF COVID-19 Oxygen therapy to maintain SpO2 target more than 94%. Low molecular weight heparin (LMWH) at preventive doses. Empirical antibiotic treatment.
Specific treatment for COVID-19 (approved by Algerian Ministry of Health) First line: Hydroxychloroquin: 200 mg oral three times a day for 10 days, with association of Azithromycin 250 mg oral : 500 mg the first day and 250 mg once a day for 4 days. Sulfate de Zinc : 220 mg once a day for 5 days. Second line: Lopinavir/ritonavir capsule 200 mg/50 mg, oral 2 capsules each times, twice a day during 5 to 7 days.
IF AGGRAVATION OR CRITICAL ILL CONDITION AT PRESENTATION Increase oxygenation flow. Consider Glucocorticoids. 3. Consider the diagnosis of pulmonary embolism and treat with LMWH at therapeutic doses.
MANAGEMENT OF DIABETES Discontinue metformin. Start or adjust insulin doses according to personalized glycemic target of patient.
other name: MANAGEMENT OF DIABETES
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Algeria
responsible party type: Principal Investigator
investigator affiliation: Laboratoire De Recherche Sur Le Diabete, Université de Tlemcen
investigator full name: ALI LOUNICI
investigator title: Chief of Internal Medicine Department
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Severe Acute Respiratory Syndrome
mesh term: Diabetes Mellitus
sharing ipd: No