<?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>IRCT20200324046850N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-29</date_registration>
      <primary_sponsor>Abadan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of Sofosbuvir + Daclatasvir (Sovodac) and Ribavirin in Covid-19</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Sofosbuvir + Daclatasvir (Sovodac) and Ribavirin in Covid-19 Patients with Severe Symptoms</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46713</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -.</study_design>
      <phase>2</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose  + sofosbuvir (400 mg)- daclatasvir (60 mg) take one tablet daily until clinical symptoms improve. Intervention 2: Intervention group 2: lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose + ribavirin (200 mg) 6 tablets every 12 hours until clinical symptoms improve.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
-All data can be shared after the participants in the study are unrecognizable.

When:
The data access period after printing the article

To whom:
-The data in this study will be available to researchers working at academic and scientific institutions, as well as the Food and Drug Administration.

Conditions:
- Any analysis can be done with the consent of the main researcher.

Where to obtain:
-s.mobarak@abadanums.ac.ir

How to obtain:
-The researcher or pharmaceutical company can send their request to the academic email after sending the documents to confirm their original identity.

Comments:
-</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Mobark</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Deputy of Education in front of Ayatollah Jamie Airport</address>
        <city>Abadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6313833177</zip>
        <telephone>+98 61 5326 7800</telephone>
        <email>s.mobarak@abadanums.ac.ir</email>
        <affiliation>Abadan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Mobarak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>- Deputy of Education in front of Ayatollah Jamie Airport</address>
        <city>Abadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6313833177</zip>
        <telephone>+98 61 5326 7800</telephone>
        <email>S.mobarak@abadanums.ac.ir</email>
        <affiliation>Abadan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>COVID-19 patients that have positive PCR  test of nasopharyngeal sample or have bilateral multi-lobar ground glass opacity in CT scan
O2 saturation under 94% or respiratory rate above 24 or decreased level of consciousness</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>patients under 18 years
pregnant or breast feeding women
patients did not consent to participate in the study
patients who took any complementary medicine
safety problem for patients
patients with any allergy or hypersensitivity to Sofosbuvir + Daclatasvir or Ribavirin or with major interaction with other medicine</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>2019-nCOV disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose  + sofosbuvir (400 mg)- daclatasvir (60 mg) take one tablet daily until clinical symptoms improve</i_keyword>
      <i_keyword>Intervention group 2: lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose + ribavirin (200 mg) 6 tablets every 12 hours until clinical symptoms improve</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Time to clinical improvement defined as start of taking medication time to alive hospital discharge. Timepoint: The beginning of the study , the time of discharge and 21 days after discharge. Method of measurement: Medical record.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of hospitalization. Timepoint: Time of discharge. Method of measurement: Number of hospital days.</sec_outcome>
      <sec_outcome>Duration of stay at ICU. Timepoint: Daily. Method of measurement: Number of days of hospitalization in ICU.</sec_outcome>
      <sec_outcome>Mortality rate. Timepoint: Daily. Method of measurement: Medical record.</sec_outcome>
      <sec_outcome>Respiratory rate. Timepoint: Daily. Method of measurement: Count the number of breaths per minute.</sec_outcome>
      <sec_outcome>Laboratory variables. Timepoint: The beginning of the study and the time of discharge. Method of measurement: Medical record.</sec_outcome>
      <sec_outcome>Adverse events. Timepoint: Time of discharge. Method of measurement: Medical record.</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>Abadan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-18</approval_date>
        <contact_name>Abadan school of medical sciences</contact_name>
        <contact_address>-Abadan School of Medical Sciences, Deputy of Education in front of Ayatollah Jamie Airport Abadan Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
