<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/NCT04474340</url>
  </required_header>
  <id_info>
    <org_study_id>MOHKuwait</org_study_id>
    <nct_id>NCT04474340</nct_id>
  </id_info>
  <brief_title>COVID-19 Convalescent Plasma Treatment in SARS-CoV-2 Infected Patients</brief_title>
  <official_title>COVID-19 Convalescent Plasma Treatment in SARS-CoV-2 Infected Patients: Multicenter Interventional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ministry of Health, Kuwait</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ministry of Health, Kuwait</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>
      Due to the limitations of COVID-19 treatment and in the absence of licensed antiviral for&#xD;
      COVID-19, the historical choice of therapeutic convalescent plasma (CP) is considered&#xD;
      especially against RNA viruses .It was known that convalescent plasma does not only&#xD;
      neutralize the pathogens but provide passive immunomodulatory properties that allows the&#xD;
      recipient to control the exaggerated inflammatory cascade. However, still there is a lack of&#xD;
      understanding of the mechanism of action of CCP therapeutic components. Reports from open&#xD;
      label trials and case series show that CCP is safe and might be effective in severe cases&#xD;
      with COVID-19 . Therefore, the World health organisation (WHO) and Food and Drug&#xD;
      Administration (FDA) issued guidelines for the CCP usage and standardised the donor selection&#xD;
      , which was further supported by Emergency use Authorisation (EUA) .&#xD;
&#xD;
      Therefore, the aim in the current study is to assess the effect of CCP on time to clinical&#xD;
      improvement, hospital mortality and to evaluate the changes on oxygen saturation and&#xD;
      laboratory markers (lymphocyte counts and C-reactive protein) compared with standard&#xD;
      treatment alone in patients with moderate or severe COVID-19 disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective multicenter interventional observational study will be conducted in 4&#xD;
      major tertiary hospitals (Al-Sabah, Farwaniya , Mubarak Al-Kabeer and Jahra) in Kuwait .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 21, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to clinical improvement</measure>
    <time_frame>30 days</time_frame>
    <description>Time to clinical improvement is defined as a time frame from CCP administration till 30 days or discharge, defined as a 2-grade decrease on an ordinal WHO clinical scale . The WHO clinical scale based on the following 7-grade ordinal levels: 1= ambulatory, independent; 2= ambulatory with assistance; 3=hospitalised, not requiring supplemental oxygen; 4= hospitalised, requiring supplemental oxygen; 5= hospitalised, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6= hospitalised, requiring extracorporeal membrane oxygenation, invasive mechanical ventilation, or both; and 7= death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Moderate COVID-19 Pneumonia, Severe COVID-19 Pneumonia</condition>
  <condition>Pneumonia, Viral</condition>
  <arm_group>
    <arm_group_label>CCP patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient has to fulfil the inclusion/exclusion criteria of the ward or the ICU&#xD;
Valid consent.&#xD;
Request the CCP from the central blood bank (200-250 ml/dose - can be repeated again in 12 hours) this is through the local hospital blood bank.&#xD;
How to transfuse CCP:&#xD;
Dose required is 200-250 ml/hr (one dose, can be repeated in 12 hrs), max total 500ml.&#xD;
Premedication prior to administration of CCP (Acetaminophen, diphenhydramine,steriods) or according to hospital guidelines.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard COVID-19 treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>COVID-19 Convalscent Plasma</intervention_name>
    <description>The source convalescent plasma is typically collected from individuals who have recovered from COVID-19 which contains antibodies titer against SARS-CoV-2 and is administered to patients with COVID-19. Donor eligibility criteria and qualification are based on American Accredited Blood Banks ( AABB) standards , including questionnaires and relevant transfusion-transmitted infections testing are performed. Furthermore, pathogen inactivation will be performed for each unit, CCP was only collected from individuals who meet all donor eligibility requirements (21 CFR 630.10 and 21 CFR 630.15). Donors must be found positive at a diagnostic test of nasopharyngeal swab at the time of illness and positive serological test for SARS-CoV-2 antibodies after recovery. All donors should have negative HLA antibodies.</description>
    <arm_group_label>CCP patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients aged ≥18 years old ( those who are younger are involved after case based&#xD;
             discussion)&#xD;
&#xD;
          2. Confirmed laboratory diagnosis with SARS-CoV-2 ,and admission diagnosis of SARS-CoV-2.&#xD;
&#xD;
          3. Patients with moderate or severe COVID-19 (moderate COVID-19 disease defined as the&#xD;
             presence of any signs of pneumonia (fever, cough, dyspnoea fast breathing) including&#xD;
             SpO2 &gt;90 on room air , but no signs of severe pneumonia (severe pneumonia have the&#xD;
             above plus one of the following: respiratory rates &gt;30 breaths/minutes or SpO2&lt;90% on&#xD;
             room air), or admission to intensive care unit (ICU) for respiratory support (i.e.high&#xD;
             flow nasal cannula, non-invasive mechanical ventilation and intubation).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. -Contraindication to transfusion (volume overload, history of anaphylaxis to blood&#xD;
             products).&#xD;
&#xD;
          2. - Patients presenting with acute severe multiorgan failure, hemodynamic instability.&#xD;
&#xD;
        3- Severe disseminated coagulopathy (DIC), septic shock and those with expected survival of&#xD;
        less than 48 hours.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sondus AlSharidah, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MOH</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sundos Alsharida</last_name>
    <phone>0096566691663</phone>
    <email>salsharidah@moh.gov.kw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ministry Of Health</name>
      <address>
        <city>Kuwait</city>
        <country>Kuwait</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sondus AlSharidah, MD</last_name>
      <phone>0096566691663</phone>
      <email>salsharidah@moh.gov.kw</email>
    </contact>
    <investigator>
      <last_name>Sondus AlSharida, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mariam Ayed, Md</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Reem Ameen, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Najat Rouhaldeen, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fatmah Alhuraish, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Abdullah Alsaedi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wasel Aladsani, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Salem Alqahtani, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Kuwait</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ministry of Health, Kuwait</investigator_affiliation>
    <investigator_full_name>Sondus AlSharidah</investigator_full_name>
    <investigator_title>Sondus Alsharidah</investigator_title>
  </responsible_party>
  <keyword>convalescent plasma</keyword>
  <keyword>respiratory infection</keyword>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>pneumonia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Pneumonia, Viral</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
  </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/NCT04474340
org study id: MOHKuwait
nct id: NCT04474340
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Due to the limitations of COVID-19 treatment and in the absence of licensed antiviral for
      COVID-19, the historical choice of therapeutic convalescent plasma (CP) is considered
      especially against RNA viruses .It was known that convalescent plasma does not only
      neutralize the pathogens but provide passive immunomodulatory properties that allows the
      recipient to control the exaggerated inflammatory cascade. However, still there is a lack of
      understanding of the mechanism of action of CCP therapeutic components. Reports from open
      label trials and case series show that CCP is safe and might be effective in severe cases
      with COVID-19 . Therefore, the World health organisation (WHO) and Food and Drug
      Administration (FDA) issued guidelines for the CCP usage and standardised the donor selection
      , which was further supported by Emergency use Authorisation (EUA) .

      Therefore, the aim in the current study is to assess the effect of CCP on time to clinical
      improvement, hospital mortality and to evaluate the changes on oxygen saturation and
      laboratory markers (lymphocyte counts and C-reactive protein) compared with standard
      treatment alone in patients with moderate or severe COVID-19 disease.
This is a prospective multicenter interventional observational study will be conducted in 4
      major tertiary hospitals (Al-Sabah, Farwaniya , Mubarak Al-Kabeer and Jahra) in Kuwait .
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to clinical improvement
time frame: 30 days
description: Time to clinical improvement is defined as a time frame from CCP administration till 30 days or discharge, defined as a 2-grade decrease on an ordinal WHO clinical scale . The WHO clinical scale based on the following 7-grade ordinal levels: 1= ambulatory, independent; 2= ambulatory with assistance; 3=hospitalised, not requiring supplemental oxygen; 4= hospitalised, requiring supplemental oxygen; 5= hospitalised, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6= hospitalised, requiring extracorporeal membrane oxygenation, invasive mechanical ventilation, or both; and 7= death.
measure: All cause mortality
time frame: 30 days
arm group label: CCP patients
arm group type: Experimental
description: Patient has to fulfil the inclusion/exclusion criteria of the ward or the ICU
Valid consent.
Request the CCP from the central blood bank (200-250 ml/dose - can be repeated again in 12 hours) this is through the local hospital blood bank.
How to transfuse CCP:
Dose required is 200-250 ml/hr (one dose, can be repeated in 12 hrs), max total 500ml.
Premedication prior to administration of CCP (Acetaminophen, diphenhydramine,steriods) or according to hospital guidelines.
arm group label: Control
arm group type: No Intervention
description: Standard COVID-19 treatment.
intervention type: Drug
intervention name: COVID-19 Convalscent Plasma
description: The source convalescent plasma is typically collected from individuals who have recovered from COVID-19 which contains antibodies titer against SARS-CoV-2 and is administered to patients with COVID-19. Donor eligibility criteria and qualification are based on American Accredited Blood Banks ( AABB) standards , including questionnaires and relevant transfusion-transmitted infections testing are performed. Furthermore, pathogen inactivation will be performed for each unit, CCP was only collected from individuals who meet all donor eligibility requirements (21 CFR 630.10 and 21 CFR 630.15). Donors must be found positive at a diagnostic test of nasopharyngeal swab at the time of illness and positive serological test for SARS-CoV-2 antibodies after recovery. All donors should have negative HLA antibodies.
arm group label: CCP patients
criteria: 
gender: All
minimum age: 15 Years
maximum age: 85 Years
healthy volunteers: No
last name: Sondus AlSharidah, MD
role: Principal Investigator
affiliation: MOH
last name: Sundos Alsharida
phone: 0096566691663
email: salsharidah@moh.gov.kw
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Kuwait
responsible party type: Principal Investigator
investigator affiliation: Ministry of Health, Kuwait
investigator full name: Sondus AlSharidah
investigator title: Sondus Alsharidah
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Pneumonia, Viral
sharing ipd: Yes
ipd info type: Study Protocol