<?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>IRCT20171122037571N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-12</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Remdesivir in treatment of COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>A single-arm multicenter clinical trial to evaluate the safety and efficacy of Remdesivir in COVID-19 patients with progressive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46660</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: Medicine used in study was provided by International donation as Compassionate use under the supervision of the Ministry of Health and Medical Education. The study was approved by the TUMS ethics committee and received a Clinical Trial Authorization- CTA from the Food and Drug Administration before the study began.</study_design>
      <phase>2-3</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention group: In addition to standard treatment:(two-drug regimen including 500 mg chloroquine phosphate / 400 mg hydroxychloroquine sulfate; single-dose and lopinavir/ritonavir 400/100 mg BID for at least 5 days or alternatively, atazanavir OR three-drug regimen including 500 mg chloroquine phosphate / 400 mg hydroxychloroquine sulfate; single-dose and lopinavir/ritonavir 400/100 mg BID for at least 5 days and ribavirin 1200 mg BID for at least 5 days)Remdesivir is also prescribed for 5 days (for patients over 40 kg or more: Amp Remdesivir 200 mg IV infusion over 30 minutes once-daily dose, followed by 100 mg iv infusion over 30 minutes once-daily maintenance doses for next 4 days.For patients weighing less than 40 kg: Amp Remdesivir 5 mg/kg IV infusion over 30 minutes loading dose on day 1, followed by 2.5 mg/kg iv infusion over 30 minutes once-daily maintenance doses for next 4 days).</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 The DSMB decides how the results will be disseminated after reviewing the preliminary data.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamed Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>23rd Unit, 4th Floor, No. 1547, North Kargar St.,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417993337</zip>
        <telephone>+98 21 8896 3546</telephone>
        <email>ctc@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Reza Salehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital Complex, Gharib | Keshavarz intersection, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>0098 21 61190</telephone>
        <email>imamhospital@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ablility to fully understand, willingness to participate, and  signing the  informed consent form (in case of decreased level of consciousness or/ and cognitive impairment, informed consent is obtained from their legal representative)
Ages over 18 years
Patients with a definitive diagnosis of SARS-CoV-2 virus based on PCR with specific pulmonary involvement in radiography who have progressive hospital course (SpO2 &lt;85% or RR &gt; 30) despite receiving standard of care treatment protocols within 72 hours</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participants in any other clinical trial for COVID-19
Concomitant treatment with other antiviral drugs other than those recommended in the national protocol
Patients undergoing mechanical ventilation at the time of baseline
Evidence of multiorgan failure in the patient's clinical record based on the physician's diagnosis
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above 5 times the upper limit of normal (ULN)
Creatinine clearance less than 50 ml/min
The presence of any concurrent major diseases including malignancy, advanced heart failure, cirrhosis, chronic kidney disease, stroke, Alzheimer's, chronic progressive neurological diseases, etc.
Pregnant and lactating women
Possibility of being transferred  to another hospital with no access to the study drug (for any reason)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Clinically-epidemiologically diagnosed COVID-19, Probable COVID-19, Suspected COVID-19</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In addition to standard treatment:(two-drug regimen including 500 mg chloroquine phosphate / 400 mg hydroxychloroquine sulfate; single-dose and lopinavir/ritonavir 400/100 mg BID for at least 5 days or alternatively, atazanavir OR three-drug regimen including 500 mg chloroquine phosphate / 400 mg hydroxychloroquine sulfate; single-dose and lopinavir/ritonavir 400/100 mg BID for at least 5 days and ribavirin 1200 mg BID for at least 5 days)Remdesivir is also prescribed for 5 days (for patients over 40 kg or more: Amp Remdesivir 200 mg IV infusion over 30 minutes once-daily dose, followed by 100 mg iv infusion over 30 minutes once-daily maintenance doses for next 4 days.For patients weighing less than 40 kg: Amp Remdesivir 5 mg/kg IV infusion over 30 minutes loading dose on day 1, followed by 2.5 mg/kg iv infusion over 30 minutes once-daily maintenance doses for next 4 days)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Time to Clinical Improvement (TTCI): TTCI is defined as the time (in days) from initiation of study treatment until a decline of two categories from admission status on a six-category ordinal scale of clinical status which ranges from 1 (discharged) to 6 (death).6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy;3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC);2. Hospitalization, not requiring supplemental oxygen; 1. Hospital discharge.	IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation;HFNC, High-flow nasal cannula. Timepoint: Daily for 14 days. Method of measurement: Based on clinical evaluation.</prim_outcome>
      <prim_outcome>Time to Clinical recovery (TTCR): TTCR is defined as the time (in hours) from initiation of study treatment until normalization of fever, respiratory rate, and oxygen saturation, and alleviation of cough sustained for at least 72 hours.Normalization and alleviation criteria:•	Fever - ≤36.9°C or -axilla, ≤37.2 °C oral,•	Respiratory rate - ≤24/minute on room air,•	Oxygen saturation - &gt;94% on room air,•	Cough - mild or absent on a patient-reported scale of severe, moderate, mild, absent. Timepoint: Daily for 14 days. Method of measurement: Based on clinical evaluation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Percentage of patients with improved oxygen supply: Percentage of patients with improved oxygen supply (at least one step in reducing oxygen supply) including 1-no need for additional oxygen supply. 2. Nasal oxygen catheter inhalation 3. Oxygen inhalation with mask. 4- NIV 5- Ventilator. Timepoint: Daily for 14 days. Method of measurement: Based on clinical evaluation.</sec_outcome>
      <sec_outcome>PaO2 / FiO2 ratio: lowest fraction recorded in a day. Timepoint: Daily for 14 days. Method of measurement: Oximeter.</sec_outcome>
      <sec_outcome>The extent of lung involvement in CT scan. Timepoint: At baseline and 14th day. Method of measurement: Radiologist report basis.</sec_outcome>
      <sec_outcome>Any adverse event. Timepoint: During the study period. Method of measurement: Any events during the study according to the patient's report or physician's judjment.</sec_outcome>
      <sec_outcome>All cause mortality. Timepoint: During the 28 days after starting the intervention. Method of measurement: Hospital death record or statement by relatives  after discharge.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-17</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Room 105 , 5th floor, Central construction of Tehran University of Medical Sciences, Ghods intersection, Keshavarz blvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
