<?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>IRCT20200328046885N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-12</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effectiveness of two treatment regimens in patients with COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of Sovodak (sofosbuvir + Daklatasvir) and Keltra treatment regimens in patients with COVID-19: a randomized single-blind study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>300</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47565</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: How patients are randomized will be classified as randomization blocks. Patients who need hospitalization are divided into four categories based on SpO2 and high-risk groups at the beginning of the visit, including patients in the high-risk group with SaO2 below 93%, patients in the high-risk group with high or equal SaO2 93%, patients in the group Low risk with SaO2 below 93% and finally patients in the low risk group with high SaO2 or equal to 93% will be divided. High-risk criteria include age over 60, with underlying disease such as immunodeficiency, diabetes, cardiovascular disease, obstructive pulmonary disease, malignancies, immunosuppressive patients, patients undergoing chemotherapy, chronic liver disease including cirrhosis and chronic disease Kidney will be considered. In each floor, blocks of size 4 are considered so that assuming the drug combination of chloroquine + Sovodak (sofosbuvir + Daklatasvir) as drug combination A and drug combination chloroquine + Kaletra as B, permutations of blocks in the form of AABB, ABAB, BBAA , BABA, ABBA, and BAAB will be produced. The sequence of blocks is randomly determined and patients in all four classes are named, thus depending on the time of referral will be placed in these blocks in order. It should be noted that the preparation of blocks and the placement of patients in blocks (assignment of patients to treatment groups) will be done by a third party who is not directly involved in the treatment of patients. Medications will also be prescribed by the clinical staff (assistants of the relevant departments) who are not involved in conducting this study, Blinding description: Medications will also be prescribed by the clinical staff (assistants of the relevant departments) who are not involved in conducting this study. And trying to be a double-blind experiment.
Treatment regimen in group A.
Hydroxychloroquine phosphate 400 mg single dose + lupinavir / ritonavir 400/100 combination twice daily for at least 5 days
Treatment regimen in group B.
Hydroxychloroquine phosphate 400 mg every 12 hours for the first day and then 200 mg every 12 hours for 5 to 7 days + Sovodak (sofosbuvir + Daklatasvir) once a day (60/400 mg) for at least 5 to 7 days It should be noted that each treatment regimen for each patient will be placed in separate envelopes with labels known only to the prescriber (a third party who will be selected by a medical staff that is not directly involved in the study). In order to blind the contents of the tablets Sovodak (sofosbuvir + Daklatasvir) and Kaletra, in coordination with a hospital pharmacologist, will be placed inside the same capsules whose contents have been emptied.</study_design>
      <phase>3</phase>
      <hc_freetext>Covid-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: out of 300 patients, 150 patients with coronary artery from two medical centers (Rasoul Akram Hospital and Firoozgar Hospital) hydroxychloroquine phosphate treatment regimen 400 mg every 12 hours on the first day and then 200 mg every 12 hours for 5 to 7 Day + Sovodak (sofosbuvir + Daklatasvir) will be taken once a day (60/400 mg) for at least 5 to 7 days. Sovodak drug manufacturer is Faravan Rojan Mohaghegh Daroo (made in Iran) and chloroquine manufacturing company is Iran Daru (made in Iran). Intervention 2: Intervention group: out of 300 patients, 150 patients with coronary artery from two medical centers (Rasoul Akram Hospital and Firoozgar Hospital) Hydroxychloroquine phosphate treatment regimen 400 mg single dose + lupinavir / ritonavir combination 400/100 twice daily They will receive at least 5 days. The manufacturer of the drug is lupinavir / ritonavir (Kaletra), Gilead (made in Iran) and the manufacturer of chloroquine, Iran Daru (made in Iran).</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>Mahin Jamshidi Makiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Firoozgar Hospital, Beh Afarin Street, Vali Asr Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1593748711</zip>
        <telephone>+98 21 8893 7383</telephone>
        <email>Jamshidimakiani.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahin Jamshidi Makiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Firoozgar Hospital, Beh Afarin Street, Vali Asr Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1593748711</zip>
        <telephone>+98 21 8214 1711</telephone>
        <email>Jamshidimakiani.M@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Definitive diagnosis of Covid-19
Inpatients
Age older than or equal to 18 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant women
Breastfeeding women
People with decreased level of consciousness
Blood pressure less than 60/90 mm Hg
Respiratory rate above 24 hypoxia
Reduction of saturation less than 90%
Patients with various organ failure
Patients required mechanical ventilation at the time of admission</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.01</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19</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>Intervention group: out of 300 patients, 150 patients with coronary artery from two medical centers (Rasoul Akram Hospital and Firoozgar Hospital) hydroxychloroquine phosphate treatment regimen 400 mg every 12 hours on the first day and then 200 mg every 12 hours for 5 to 7 Day + Sovodak (sofosbuvir + Daklatasvir) will be taken once a day (60/400 mg) for at least 5 to 7 days. Sovodak drug manufacturer is Faravan Rojan Mohaghegh Daroo (made in Iran) and chloroquine manufacturing company is Iran Daru (made in Iran).</i_keyword>
      <i_keyword>Intervention group: out of 300 patients, 150 patients with coronary artery from two medical centers (Rasoul Akram Hospital and Firoozgar Hospital) Hydroxychloroquine phosphate treatment regimen 400 mg single dose + lupinavir / ritonavir combination 400/100 twice daily They will receive at least 5 days. The manufacturer of the drug is lupinavir / ritonavir (Kaletra), Gilead (made in Iran) and the manufacturer of chloroquine, Iran Daru (made in Iran).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Death. Timepoint: 14,3,2,1,0 days after the start of the intervention. Method of measurement: The ratio of death to total patients in each group.</prim_outcome>
      <prim_outcome>Recovery and discharge from the hospital. Timepoint: End of treatment. Method of measurement: Examine the patient and perform tests.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of hospitalization. Timepoint: End of study. Method of measurement: File information.</sec_outcome>
      <sec_outcome>Need to be admitted to the ICU (Intensive care units). Timepoint: After the intervention. Method of measurement: See the patient's clinical signs and tests.</sec_outcome>
      <sec_outcome>Requires four drug treatments. Timepoint: During treatment. Method of measurement: Patient examination.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-19</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, next to Milad Tower, Hemat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
