<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/NCT04460547</url>
  </required_header>
  <id_info>
    <org_study_id>COAHS</org_study_id>
    <nct_id>NCT04460547</nct_id>
  </id_info>
  <brief_title>Worldwide Trends on COVID-19 Research After the Declaration of COVID-19 Pandemic</brief_title>
  <official_title>Worldwide Trends on COVID-19 Research After the Declaration of COVID-19 Pandemic: An Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Qassim University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Qassim University</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>
      On 11th of March 2020, WHO characterized COVID-19 infection as a Pandemic. After the COVID-19&#xD;
      infection is declared as a Pandemic there was an outburst regarding COVID-19 Research. The&#xD;
      Research interest led to registration of Interventional and Observational studies world wide.&#xD;
      There are constant efforts by Health care workers to seek information regarding the&#xD;
      Interventional and Observational studies which can help in decision making regarding&#xD;
      effective handling of COVID-19 infected patients. It is also important to track on the&#xD;
      happenings in various frontiers of COVID-19 Research in view of historical interest and&#xD;
      clinical relevance. This Observational Cross sectional study aims to explore the completed&#xD;
      Researches in WHO-compliant registries to understand the trends of COVID-19 Research. This&#xD;
      study aims to get a birds eye view of ongoing COVID-19 Research scenario worldwide. This&#xD;
      study results can directly benefit the worldwide Academicians and Health Care Professionals&#xD;
      to understand the ongoing COVID-19 Research trends.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      On 11th of March 2020, WHO characterized COVID-19 infection as a Pandemic. After the COVID-19&#xD;
      infection is declared as a Pandemic there was an outburst regarding COVID-19 Research. The&#xD;
      Research interest led to registration of Interventional and Observational studies world wide.&#xD;
&#xD;
      AIMs &amp; Objectives of the Study This Observational Cross sectional study aims to explore the&#xD;
      completed Researches in WHO-compliant registries to understand the trends of COVID-19&#xD;
      Research.&#xD;
&#xD;
      This study results can directly benefit the worldwide Academicians and Health Care&#xD;
      Professionals to understand the ongoing COVID-19 Research trends.&#xD;
&#xD;
      Primary Outcomes of the Study To understand the geographical distribution of the&#xD;
      interventional studies after 11th of March 2020.&#xD;
&#xD;
      To understand the geographical distribution of the Observational studies after 11th of March&#xD;
      2020.&#xD;
&#xD;
      To understand the monthly Research study completion rate as per geographic distribution of&#xD;
      the Research.&#xD;
&#xD;
      Secondary Outcomes of the Study To understand the statistical correlation of the&#xD;
      interventional studies Research with developed, developing and under developed countries.&#xD;
&#xD;
      To understand the statistical correlation of the observational studies Research with&#xD;
      developed, developing and under developed countries.&#xD;
&#xD;
      To understand the statistical correlation of the Drug based interventional studies Research&#xD;
      with developed, developing and under developed countries.&#xD;
&#xD;
      To understand the statistical correlation of the Diagnostic test based interventional studies&#xD;
      Research with developed, developing and under developed countries.&#xD;
&#xD;
      To understand the statistical correlation of the Device based interventional studies Research&#xD;
      with developed, developing and under developed countries.&#xD;
&#xD;
      Methodology WHO-compliant registries will be explored for completed COVID-19 Research&#xD;
      articles.&#xD;
&#xD;
      Inclusion Criteria Interventional studies in the WHO-compliant registries database which are&#xD;
      registered and completed after 11th of March 2020 until 15th of August 2020.&#xD;
&#xD;
      Observational studies in the WHO-compliant registries database which are registered and&#xD;
      completed after 11th of March 2020 until 15th of August 2020.&#xD;
&#xD;
      Exclusion Criteria Interventional studies in the WHO-compliant registries database which are&#xD;
      registered and completed before 11th March 2020.&#xD;
&#xD;
      Observational studies in the WHO-compliant registries database which are registered and&#xD;
      completed before 11th March 2020.&#xD;
&#xD;
      The articles selected from the WHO-compliant registries database will be categorized as per&#xD;
      following relevance:&#xD;
&#xD;
      Interventional Studies: Theses studies will be further categorized based on type of&#xD;
      Intervention. Inteventional studies can be Drug, Diagnostic tests, Rehabilitation, Procedure,&#xD;
      Device, Behavioral, Dietary supplement, Biological, Physiotherapy &amp; Others types of&#xD;
      Interventional study.&#xD;
&#xD;
      Observational Studies: Prospective and Retrospective Observational studies.&#xD;
&#xD;
      The Studies will be mapped according to the Country where the Research is completed and the&#xD;
      type of Research.&#xD;
&#xD;
      Type of Variables studied in this Study 6 Continuous variables are studied in this Study&#xD;
      Number of Interventional Studies (Continuous variable) Number of Observational Studies&#xD;
      (Continuous variable) Number of Drug based Interventional Study (Continuous variable) Number&#xD;
      of Diagnostic test based interventional study (Continuous variable) Number of Device based&#xD;
      interventional study (Continuous variable) Monthly Research study completion rate (Continuous&#xD;
      variable)&#xD;
&#xD;
      8 Categorical variables will be studies in this study Interventional Study (Categorical&#xD;
      variable) Observational Study (Categorical variable) Developed country (Categorical variable)&#xD;
      Developing country (Categorical variable) Under developed country (Categorical variable) Drug&#xD;
      based Interventional Study (Categorical variable) Diagnostic test based interventional study&#xD;
      (Categorical variable) Device based interventional study (Categorical variable)&#xD;
&#xD;
      Statistical Analysis Data analysis will be carried out using SPSS 22.00 (Stata Corp, College&#xD;
      Station, TX, USA). The Data obtained will be analysed for the normal distribution. If the&#xD;
      data follows normal distribution curve, Pearson Correlation statistical test will be used to&#xD;
      assess the Correlation of categorical and continuous variables. If the data does not follow&#xD;
      normal distribution curve, Spearman Correlation or Chi square statistical test will be used&#xD;
      to assess the Correlation of Categorical and continuous variables. The p-value (significance&#xD;
      level) of the correlation will be determined. If the p-value is &lt;5%, then the correlation&#xD;
      between variables analysed will be considered as significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 25, 2020</start_date>
  <completion_date type="Anticipated">September 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 15, 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>Geographical distribution of the interventional studies after 11th of March 2020.</measure>
    <time_frame>15th of August 2020</time_frame>
    <description>To understand the geographical distribution of the interventional studies after 11th of March 2020.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geographical distribution of the Observational studies after 11th of March 2020.</measure>
    <time_frame>15th of August 2020</time_frame>
    <description>To understand the geographical distribution of the Observational studies after 11th of March 2020.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Monthly Research study completion rate as per geographic distribution of the Research.</measure>
    <time_frame>15th of August 2020</time_frame>
    <description>To understand the monthly Research study completion rate as per geographic distribution of the Research.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Statistical correlation of the interventional studies Research with developed, developing and under developed countries.</measure>
    <time_frame>15th of August 2020</time_frame>
    <description>To understand the statistical correlation of the interventional studies Research with developed, developing and under developed countries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Statistical correlation of the observational studies Research with developed, developing and under developed countries.</measure>
    <time_frame>15th of August 2020</time_frame>
    <description>To understand the statistical correlation of the observational studies Research with developed, developing and under developed countries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Statistical correlation of the Drug based interventional studies Research with developed, developing and under developed countries.</measure>
    <time_frame>15th of August 2020</time_frame>
    <description>To understand the statistical correlation of the Drug based interventional studies Research with developed, developing and under developed countries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Statistical correlation of the Diagnostic test based interventional studies Research with developed, developing and under developed countries.</measure>
    <time_frame>15th of August 2020</time_frame>
    <description>To understand the statistical correlation of the Diagnostic test based interventional studies Research with developed, developing and under developed countries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Statistical correlation of the Device based interventional studies Research with developed, developing and under developed countries.</measure>
    <time_frame>15th of August 2020</time_frame>
    <description>To understand the statistical correlation of the Device based interventional studies Research with developed, developing and under developed countries.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Completed Interventional studies</arm_group_label>
    <description>Interventional studies in the WHO-compliant registries database which are registered and completed before 11th March 2020.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Completed Observational studies</arm_group_label>
    <description>Observational studies in the WHO-compliant registries database which are registered and completed before 11th March 2020.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Convalescent Plasma Transfusion</intervention_name>
    <description>Convalescent Plasma Transfusion to COVID-19 infected patients.</description>
    <arm_group_label>Completed Interventional studies</arm_group_label>
    <arm_group_label>Completed Observational studies</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydroxychloroquine</intervention_name>
    <description>Hydroxychloroquine administration to COVID-19 infected patients.</description>
    <arm_group_label>Completed Interventional studies</arm_group_label>
    <arm_group_label>Completed Observational studies</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DAS181</intervention_name>
    <description>DAS181 administration to COVID-19 infected patients.</description>
    <arm_group_label>Completed Interventional studies</arm_group_label>
    <arm_group_label>Completed Observational studies</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ivermectin</intervention_name>
    <description>Ivermectin administration to COVID-19 infected patients.</description>
    <arm_group_label>Completed Interventional studies</arm_group_label>
    <arm_group_label>Completed Observational studies</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Interferon Beta-1A</intervention_name>
    <description>Interferon Beta-1A administration to COVID-19 infected patients.</description>
    <arm_group_label>Completed Interventional studies</arm_group_label>
    <arm_group_label>Completed Observational studies</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who are infected with COVID-19. Healthy Volunteers who respond to survey. Subjects&#xD;
        who have recently recovered from COVID-19 infection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Interventional studies in the WHO-compliant registries database which are registered and&#xD;
        completed after 11th of March 2020 until 15th of August 2020.&#xD;
&#xD;
        Observational studies in the WHO-compliant registries database which are registered and&#xD;
        completed after 11th of March 2020 until 15th of August 2020.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Interventional studies in the WHO-compliant registries database which are registered and&#xD;
        completed before 11th March 2020.&#xD;
&#xD;
        Observational studies in the WHO-compliant registries database which are registered and&#xD;
        completed before 11th March 2020.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 3, 2020</last_update_submitted>
  <last_update_submitted_qc>July 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Qassim University</investigator_affiliation>
    <investigator_full_name>Dr Shiva Shankar Bugude</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Research trends, COVID-19, Pandemic, Interventional studies, Observational studies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Interferons</mesh_term>
    <mesh_term>Interferon-beta</mesh_term>
    <mesh_term>Interferon beta-1a</mesh_term>
    <mesh_term>Hydroxychloroquine</mesh_term>
    <mesh_term>Ivermectin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The Research data will be extracted from the WHO-compliant registry databases.</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/NCT04460547
org study id: COAHS
nct id: NCT04460547
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
On 11th of March 2020, WHO characterized COVID-19 infection as a Pandemic. After the COVID-19
      infection is declared as a Pandemic there was an outburst regarding COVID-19 Research. The
      Research interest led to registration of Interventional and Observational studies world wide.
      There are constant efforts by Health care workers to seek information regarding the
      Interventional and Observational studies which can help in decision making regarding
      effective handling of COVID-19 infected patients. It is also important to track on the
      happenings in various frontiers of COVID-19 Research in view of historical interest and
      clinical relevance. This Observational Cross sectional study aims to explore the completed
      Researches in WHO-compliant registries to understand the trends of COVID-19 Research. This
      study aims to get a birds eye view of ongoing COVID-19 Research scenario worldwide. This
      study results can directly benefit the worldwide Academicians and Health Care Professionals
      to understand the ongoing COVID-19 Research trends.
On 11th of March 2020, WHO characterized COVID-19 infection as a Pandemic. After the COVID-19
      infection is declared as a Pandemic there was an outburst regarding COVID-19 Research. The
      Research interest led to registration of Interventional and Observational studies world wide.

      AIMs & Objectives of the Study This Observational Cross sectional study aims to explore the
      completed Researches in WHO-compliant registries to understand the trends of COVID-19
      Research.

      This study results can directly benefit the worldwide Academicians and Health Care
      Professionals to understand the ongoing COVID-19 Research trends.

      Primary Outcomes of the Study To understand the geographical distribution of the
      interventional studies after 11th of March 2020.

      To understand the geographical distribution of the Observational studies after 11th of March
      2020.

      To understand the monthly Research study completion rate as per geographic distribution of
      the Research.

      Secondary Outcomes of the Study To understand the statistical correlation of the
      interventional studies Research with developed, developing and under developed countries.

      To understand the statistical correlation of the observational studies Research with
      developed, developing and under developed countries.

      To understand the statistical correlation of the Drug based interventional studies Research
      with developed, developing and under developed countries.

      To understand the statistical correlation of the Diagnostic test based interventional studies
      Research with developed, developing and under developed countries.

      To understand the statistical correlation of the Device based interventional studies Research
      with developed, developing and under developed countries.

      Methodology WHO-compliant registries will be explored for completed COVID-19 Research
      articles.

      Inclusion Criteria Interventional studies in the WHO-compliant registries database which are
      registered and completed after 11th of March 2020 until 15th of August 2020.

      Observational studies in the WHO-compliant registries database which are registered and
      completed after 11th of March 2020 until 15th of August 2020.

      Exclusion Criteria Interventional studies in the WHO-compliant registries database which are
      registered and completed before 11th March 2020.

      Observational studies in the WHO-compliant registries database which are registered and
      completed before 11th March 2020.

      The articles selected from the WHO-compliant registries database will be categorized as per
      following relevance:

      Interventional Studies: Theses studies will be further categorized based on type of
      Intervention. Inteventional studies can be Drug, Diagnostic tests, Rehabilitation, Procedure,
      Device, Behavioral, Dietary supplement, Biological, Physiotherapy & Others types of
      Interventional study.

      Observational Studies: Prospective and Retrospective Observational studies.

      The Studies will be mapped according to the Country where the Research is completed and the
      type of Research.

      Type of Variables studied in this Study 6 Continuous variables are studied in this Study
      Number of Interventional Studies (Continuous variable) Number of Observational Studies
      (Continuous variable) Number of Drug based Interventional Study (Continuous variable) Number
      of Diagnostic test based interventional study (Continuous variable) Number of Device based
      interventional study (Continuous variable) Monthly Research study completion rate (Continuous
      variable)

      8 Categorical variables will be studies in this study Interventional Study (Categorical
      variable) Observational Study (Categorical variable) Developed country (Categorical variable)
      Developing country (Categorical variable) Under developed country (Categorical variable) Drug
      based Interventional Study (Categorical variable) Diagnostic test based interventional study
      (Categorical variable) Device based interventional study (Categorical variable)

      Statistical Analysis Data analysis will be carried out using SPSS 22.00 (Stata Corp, College
      Station, TX, USA). The Data obtained will be analysed for the normal distribution. If the
      data follows normal distribution curve, Pearson Correlation statistical test will be used to
      assess the Correlation of categorical and continuous variables. If the data does not follow
      normal distribution curve, Spearman Correlation or Chi square statistical test will be used
      to assess the Correlation of Categorical and continuous variables. The p-value (significance
      level) of the correlation will be determined. If the p-value is <5%, then the correlation
      between variables analysed will be considered as significant.
observational model: Cohort
time perspective: Retrospective
measure: Geographical distribution of the interventional studies after 11th of March 2020.
time frame: 15th of August 2020
description: To understand the geographical distribution of the interventional studies after 11th of March 2020.
measure: Geographical distribution of the Observational studies after 11th of March 2020.
time frame: 15th of August 2020
description: To understand the geographical distribution of the Observational studies after 11th of March 2020.
measure: Monthly Research study completion rate as per geographic distribution of the Research.
time frame: 15th of August 2020
description: To understand the monthly Research study completion rate as per geographic distribution of the Research.
measure: Statistical correlation of the interventional studies Research with developed, developing and under developed countries.
time frame: 15th of August 2020
description: To understand the statistical correlation of the interventional studies Research with developed, developing and under developed countries.
measure: Statistical correlation of the observational studies Research with developed, developing and under developed countries.
time frame: 15th of August 2020
description: To understand the statistical correlation of the observational studies Research with developed, developing and under developed countries.
measure: Statistical correlation of the Drug based interventional studies Research with developed, developing and under developed countries.
time frame: 15th of August 2020
description: To understand the statistical correlation of the Drug based interventional studies Research with developed, developing and under developed countries.
measure: Statistical correlation of the Diagnostic test based interventional studies Research with developed, developing and under developed countries.
time frame: 15th of August 2020
description: To understand the statistical correlation of the Diagnostic test based interventional studies Research with developed, developing and under developed countries.
measure: Statistical correlation of the Device based interventional studies Research with developed, developing and under developed countries.
time frame: 15th of August 2020
description: To understand the statistical correlation of the Device based interventional studies Research with developed, developing and under developed countries.
arm group label: Completed Interventional studies
description: Interventional studies in the WHO-compliant registries database which are registered and completed before 11th March 2020.
arm group label: Completed Observational studies
description: Observational studies in the WHO-compliant registries database which are registered and completed before 11th March 2020.
intervention type: Drug
intervention name: Convalescent Plasma Transfusion
description: Convalescent Plasma Transfusion to COVID-19 infected patients.
arm group label: Completed Interventional studies
arm group label: Completed Observational studies
intervention type: Drug
intervention name: Hydroxychloroquine
description: Hydroxychloroquine administration to COVID-19 infected patients.
arm group label: Completed Interventional studies
arm group label: Completed Observational studies
intervention type: Drug
intervention name: DAS181
description: DAS181 administration to COVID-19 infected patients.
arm group label: Completed Interventional studies
arm group label: Completed Observational studies
intervention type: Drug
intervention name: Ivermectin
description: Ivermectin administration to COVID-19 infected patients.
arm group label: Completed Interventional studies
arm group label: Completed Observational studies
intervention type: Drug
intervention name: Interferon Beta-1A
description: Interferon Beta-1A administration to COVID-19 infected patients.
arm group label: Completed Interventional studies
arm group label: Completed Observational studies
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
responsible party type: Principal Investigator
investigator affiliation: Qassim University
investigator full name: Dr Shiva Shankar Bugude
investigator title: Assistant Professor
mesh term: COVID-19
mesh term: Interferons
mesh term: Interferon-beta
mesh term: Interferon beta-1a
mesh term: Hydroxychloroquine
mesh term: Ivermectin
sharing ipd: No
ipd description: The Research data will be extracted from the WHO-compliant registry databases.