<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200417047113N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-24</date_registration>
      <primary_sponsor>Middle East Gene Therapy corporation</primary_sponsor>
      <public_title>Effect of NK cell therapy in COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the safety and efficacy of allogeneic NK cells on COVID-19 induced pneumonia, double blind, randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47264</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned to one of the 7 study groups using random number table and receive intervention from the same group, Blinding description: In this study all participants will be blinded, including COVID-19 patients, the principal investigator who is an infectious disease specialist, as well as all physicians, nurses and treatment teams, as well as data collection officials and those who assessed the consequences after interventions. The patients in the study are divided into distinct groups according to the random algorithm. َA code is considered for each person and placed in an envelope, or a electronic file then presented to the physicians and the nurses. Elsewhere, it is clear that the code is related to the drug or placebo. When prescribing, the patient's code must be matched with the code on the cell product by the responsible physician and nurse. Only if the person's health is compromised, the code will be broken prematurely. This code also is unique for each individual, and if a code is broken, physician and researcher will not know the other patient's codes.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Condition 1: COVID-19. Condition 2: COVID-19. Condition 3: Viral pneumonia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: treatment group A, 0.1 * 107 NK cells per kilogram of patient weight. The lowest dose of cells will be injected into this treatment cohort. These patients will be examined at intervals 1, 3, 7, 14, 28 after cell injection for safety and efficacy effects. Intervention 2: Intervention group 2: treatment group B, 0.5 * 107 NK cells per kilogram of patient weight. The middle dose of the cells will be injected into this treatment cohort. These patients will be examined at intervals 1, 3, 7, 14, 28 after injection for safety and efficacy effects. Intervention 3: Intervention group 3: treatment group C, 1 * 107 NK cells per kilogram of patient weight. The middle dose of the cells will be injected into this treatment cohort. These patients will be examined at intervals 1, 3, 7, 14, 28 after injection for safety and efficacy effects. Intervention 4: Intervention group 4: treatment group D, 1.5 * 107 NK cells per kilogram of patient weight. The middle dose of the cells will be injected into this treatment cohort. These patients will be examined at intervals 1, 3, 7, 14, 28 after injection for safety and efficacy effects. Intervention 5: Intervention group 5: treatment group E, 2 * 107 NK cells per kilogram of patient weight. The highest dose of cells will be injected into this treatment cohort. These patients will also be examined at intervals of 1, 3, 7, 14, 28 days in terms of safety and effectiveness outcomes. Intervention 6: Intervention group 6: placebo, in this group, only physiological serum will be injected into patients. These patients will also be examined at intervals of 1, 3, 7, 14, 28 days in terms of safety and effectiveness outcomes. Intervention 7: Control group: They do not receive any treatment other than common medications. These patients will also be examined at intervals of 1, 3, 7, 14, 28 days in terms of safety and effectiveness outcomes.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sahar Shojaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Middle East Gene Therapy Co., Pajoohesh boulevard, Hamedani highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14965161</zip>
        <telephone>+98 21 4478 7327</telephone>
        <email>S.shojaei@megenetherapy.com</email>
        <affiliation>Middle East Gene Therapy Corporation</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sahar Shojaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Middle East Gene Therapy Co., Pajoohesh boulevard, Hamedani highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14965161</zip>
        <telephone>+98 21 4478 7327</telephone>
        <email>shojaeisahar@gmail.com</email>
        <affiliation>Middle East Gene Therapy Corporation</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All COVID-19 patients confirmed by CT scan with possitive RT-PCR</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy or breastfeeding
Known HIV, HBV or HCV infection
Patients with malignant tumor, other serious systemic diseases and psychosis
Diabetic patients
Patients who are participating in other clinical trials</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
      <hc_code>U07.2</hc_code>
      <hc_code>J12.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus identified</hc_keyword>
      <hc_keyword>COVID-19, virus not identified</hc_keyword>
      <hc_keyword>Other viral pneumonia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: treatment group A, 0.1 * 107 NK cells per kilogram of patient weight. The lowest dose of cells will be injected into this treatment cohort. These patients will be examined at intervals 1, 3, 7, 14, 28 after cell injection for safety and efficacy effects.</i_keyword>
      <i_keyword>Intervention group 2: treatment group B, 0.5 * 107 NK cells per kilogram of patient weight. The middle dose of the cells will be injected into this treatment cohort. These patients will be examined at intervals 1, 3, 7, 14, 28 after injection for safety and efficacy effects.</i_keyword>
      <i_keyword>Intervention group 3: treatment group C, 1 * 107 NK cells per kilogram of patient weight. The middle dose of the cells will be injected into this treatment cohort. These patients will be examined at intervals 1, 3, 7, 14, 28 after injection for safety and efficacy effects.</i_keyword>
      <i_keyword>Intervention group 4: treatment group D, 1.5 * 107 NK cells per kilogram of patient weight. The middle dose of the cells will be injected into this treatment cohort. These patients will be examined at intervals 1, 3, 7, 14, 28 after injection for safety and efficacy effects.</i_keyword>
      <i_keyword>Intervention group 5: treatment group E, 2 * 107 NK cells per kilogram of patient weight. The highest dose of cells will be injected into this treatment cohort. These patients will also be examined at intervals of 1, 3, 7, 14, 28 days in terms of safety and effectiveness outcomes.</i_keyword>
      <i_keyword>Intervention group 6: placebo, in this group, only physiological serum will be injected into patients. These patients will also be examined at intervals of 1, 3, 7, 14, 28 days in terms of safety and effectiveness outcomes.</i_keyword>
      <i_keyword>Control group: They do not receive any treatment other than common medications. These patients will also be examined at intervals of 1, 3, 7, 14, 28 days in terms of safety and effectiveness outcomes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fever. Timepoint: Days 1, 3, 7, 14, and 28. Method of measurement: Thermometer.</prim_outcome>
      <prim_outcome>Number of breathes per minute. Timepoint: Days 1, 3, 7, 14, and 28 after cell injection. Method of measurement: Records of the number of breaths in a minute by Nurse in 3 consecutive minutes.</prim_outcome>
      <prim_outcome>Pulmonary volume. Timepoint: Days 7 and 14. Method of measurement: Spirometer.</prim_outcome>
      <prim_outcome>Pulmonary capacity. Timepoint: Days 7 and 14. Method of measurement: Spirometer.</prim_outcome>
      <prim_outcome>Airway resistance. Timepoint: Days 7 and 14. Method of measurement: Spirometer.</prim_outcome>
      <prim_outcome>Lung elasticity. Timepoint: Days 7 and 14. Method of measurement: Spirometer.</prim_outcome>
      <prim_outcome>Chest pressure. Timepoint: Days 7 and 14. Method of measurement: Spirometer.</prim_outcome>
      <prim_outcome>Cough. Timepoint: Days 1, 3, 7, 14, and 28 after cell injection. Method of measurement: Records in questionnaire by nurse according to defined qualitative criteria.</prim_outcome>
      <prim_outcome>Skin disorders. Timepoint: Days 1, 3, 7, 14, and 28. Method of measurement: Records in questionnaire by nurse according to defined qualitative criteria.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lymphopenia. Timepoint: Day 7. Method of measurement: Complete blood count.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Middle East Gene Therapy corporation</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-21</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>No. 226, Qods street, Keshavarz boulevard Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
