<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/NCT04441424</url>
  </required_header>
  <id_info>
    <org_study_id>CPT-COVID-19</org_study_id>
    <nct_id>NCT04441424</nct_id>
  </id_info>
  <brief_title>Convalescent Plasma Therapy on Critically-ill Novel Coronavirus (COVID-19) Patients</brief_title>
  <official_title>The Therapeutic Potential of Convalescent Plasma Therapy on Treating Critically-ill COVID-19 Patients Residing in Respiratory Care Units in Hospitals in Baghdad, Iraq</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alkarkh Health Directorate-Baghdad</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alkarkh Health Directorate-Baghdad</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>
      Out of 49 early-stage critically-ill COVID-19 patients, 21 patients are the experimental&#xD;
      group who take convalescent plasma compared to 28 patients receive only conventional therapy&#xD;
      without taking Convalescent plasma. Recovery or death, length of stay in hospital, and&#xD;
      improvement in the clinical course of the disease are monitored in relation to monitoring&#xD;
      through severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) RNA detection via poly&#xD;
      chain reaction (PCR), and SARS-CoV-2 immunoglobulin G (IgG) and immunoglobulin M (IgM)&#xD;
      serological monitoring.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives: The current COVID-19 pandemic needs unconventional therapies to tackle the&#xD;
      resulted high morbidity and mortality. Convalescent plasma is one of the therapeutic&#xD;
      approaches that might be of benefit. Methods: Forty nine early-stage critically-ill COVID-19&#xD;
      patients residing in respiratory care units (RCU) of three hospitals in Baghdad, Iraq were&#xD;
      included, 21 received convalescent plasma while 28 did not receive, namely control group.&#xD;
      Recovery or death, length of stay in hospital, and improvement in the clinical course of the&#xD;
      disease were monitored clinically along with laboratory monitoring through SARS-CoV-2 RNA&#xD;
      detection via PCR, and SARS-CoV-2 IgG and IgM serological monitoring.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2020</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Death versus survival of treated patients</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>evaluate the role of convalescent plasma in saving life of treated patients by measuring the final outcome whether treated patients survived or died</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The length of stay in hospitals</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>this outcome is about measuring the length of stay (in days) of treated patients with convalescent plasma versus tose who were treated with conventional therapies</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>IMMUNOTHERAPY</condition>
  <arm_group>
    <arm_group_label>Convalescent plasma group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>21 critically-ill COVID-19 patients were given convalescent plasma: 400 ml of convalescent plasma from COVID-19 recovered subjects. The plasma infusion lasts for one hour.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This group is 28 critically-ill COVID-19 patients who are at the same disease stage to those of experimental group that were treated with conventional therapy without taking convalescent plasma.&#xD;
The conventional therapy: 400 mg once PO Hydroxychloroquine/day with 250mg once PO Azithromycin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Convalescent plasma</intervention_name>
    <description>400 ml of convalescent plasma (plasma taken 2 weeks from the recovered COVID-19 patients) and was transfused over 1-2 hours to the recipients by blood donation set.</description>
    <arm_group_label>Convalescent plasma group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydroxychloroquin with Azithromycin</intervention_name>
    <description>The control group of COVID-19 patients were given the conventional therapy approved in Iraq for COVID-19, namely Hydroxychloroquine 400mg PO twice per day for 5 days and Azithromycin once PO 500 mg per day for 5 days.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Convalescent plasma group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  49 critically-ill COVID-19 patients are included.&#xD;
&#xD;
          -  All of the patients were with pneumonia and residing in RCU&#xD;
&#xD;
          -  Age ≥ 18 y&#xD;
&#xD;
          -  With dyspnea and oxygen saturation less than 90% in resting state.&#xD;
&#xD;
          -  At their first 3 days in RCU either receiving O2 therapy, c-pap, or on ventilators.&#xD;
&#xD;
          -  All of the patients were residing in infectious diseases wards before being&#xD;
             transferred to RCU.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The exclusion criteria of the COVID-19 patients were:&#xD;
&#xD;
               -  Previous allergic history to plasma or its ingredients such as sodium citrate.&#xD;
&#xD;
               -  Cases with serious general conditions, such as severe organ dysfunction, that are&#xD;
                  not suitable for transfusion.&#xD;
&#xD;
               -  Very late stage of the acute respiratory distress (ARDS) where Convalescent&#xD;
                  plasma (CP) has proved to be of low therapeutic benefit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed S Abdulamir, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alkarkh health directorate</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Akarkh Healt hdirectorate</name>
      <address>
        <city>Baghdad</city>
        <zip>14222</zip>
        <country>Iraq</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iraq</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 20, 2020</last_update_submitted>
  <last_update_submitted_qc>June 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alkarkh Health Directorate-Baghdad</investigator_affiliation>
    <investigator_full_name>Ahmed Sahib Abdulamir</investigator_full_name>
    <investigator_title>Professor in Virology and infectious diseases</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azithromycin</mesh_term>
    <mesh_term>Hydroxychloroquine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT04441424/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04441424
org study id: CPT-COVID-19
nct id: NCT04441424
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Out of 49 early-stage critically-ill COVID-19 patients, 21 patients are the experimental
      group who take convalescent plasma compared to 28 patients receive only conventional therapy
      without taking Convalescent plasma. Recovery or death, length of stay in hospital, and
      improvement in the clinical course of the disease are monitored in relation to monitoring
      through severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) RNA detection via poly
      chain reaction (PCR), and SARS-CoV-2 immunoglobulin G (IgG) and immunoglobulin M (IgM)
      serological monitoring.
Objectives: The current COVID-19 pandemic needs unconventional therapies to tackle the
      resulted high morbidity and mortality. Convalescent plasma is one of the therapeutic
      approaches that might be of benefit. Methods: Forty nine early-stage critically-ill COVID-19
      patients residing in respiratory care units (RCU) of three hospitals in Baghdad, Iraq were
      included, 21 received convalescent plasma while 28 did not receive, namely control group.
      Recovery or death, length of stay in hospital, and improvement in the clinical course of the
      disease were monitored clinically along with laboratory monitoring through SARS-CoV-2 RNA
      detection via PCR, and SARS-CoV-2 IgG and IgM serological monitoring.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Death versus survival of treated patients
time frame: Up to 8 weeks
description: evaluate the role of convalescent plasma in saving life of treated patients by measuring the final outcome whether treated patients survived or died
measure: The length of stay in hospitals
time frame: Up to 8 weeks
description: this outcome is about measuring the length of stay (in days) of treated patients with convalescent plasma versus tose who were treated with conventional therapies
arm group label: Convalescent plasma group
arm group type: Experimental
description: 21 critically-ill COVID-19 patients were given convalescent plasma: 400 ml of convalescent plasma from COVID-19 recovered subjects. The plasma infusion lasts for one hour.
arm group label: Control group
arm group type: Other
description: This group is 28 critically-ill COVID-19 patients who are at the same disease stage to those of experimental group that were treated with conventional therapy without taking convalescent plasma.
The conventional therapy: 400 mg once PO Hydroxychloroquine/day with 250mg once PO Azithromycin.
intervention type: Biological
intervention name: Convalescent plasma
description: 400 ml of convalescent plasma (plasma taken 2 weeks from the recovered COVID-19 patients) and was transfused over 1-2 hours to the recipients by blood donation set.
arm group label: Convalescent plasma group
intervention type: Drug
intervention name: Hydroxychloroquin with Azithromycin
description: The control group of COVID-19 patients were given the conventional therapy approved in Iraq for COVID-19, namely Hydroxychloroquine 400mg PO twice per day for 5 days and Azithromycin once PO 500 mg per day for 5 days.
arm group label: Control group
arm group label: Convalescent plasma group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ahmed S Abdulamir, PhD
role: Principal Investigator
affiliation: Alkarkh health directorate
facility: 
country: Iraq
responsible party type: Principal Investigator
investigator affiliation: Alkarkh Health Directorate-Baghdad
investigator full name: Ahmed Sahib Abdulamir
investigator title: Professor in Virology and infectious diseases
mesh term: Critical Illness
mesh term: Azithromycin
mesh term: Hydroxychloroquine
sharing ipd: No
provided document: 