<?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>IRCT20200718048129N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-11</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effectiveness of Hydroxychloroquine and Clarithromycin in dyspnea and caugh caused by COVID-19 in recovery phase</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation and comparison of the effectiveness of Hydroxychloroquin versus Clarithromycin in recovery of dyspnea and Caugh at the end of the acute phase of COVID-19 treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49729</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In our study, the simple randomization method is used as follows. A number of sealed envelopes in which study groups with letters A, intervention group with hydroxychloroquine, group B, intervention with clarithromycin and group C, including the control group, have been identified.The number of envelopes in each group is equal in number. The cards are merged and a card is randomly selected for each referring patient, thus assigning the patient to one of the groups. The removed card is then returned to the other cards. This process continues until a random sequence is reached according to the sample size in each group.</study_design>
      <phase>3</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Hydroxychloroquine tablets 200 mg every 12 hours for  one month fram Rooz daroo company. Intervention 2: Intervention group 2: Clarithromycin 500 mg capsules every 12 hours for one month from Tehran shimi company. Intervention 3: Control group: without receiving medication during a one-month follow-up.</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 provided data after unidentifying the subjects, include demographic information and characteristics of their disease in the acute phase, along with a description of the first visit and tests taken from patients at that time. The type of performed intervention for each patient and patients' clinical condition change after Intervention practices and finally the method  of data analysis are the other documents which can be provided.

When:
Access started 6 months after the results were published

To whom:
Researchers working in academic and scientific institutions

Conditions:
In order to conduct further research, any analysis other than those used in this study is acceptable with the permission of the research agent.

Where to obtain:
Dr. Sima Bahrami
Address: Allergy and Immunology Clinic,Hazrat Rasoul Hospital, Niayesh St - Sattarkhan Av. Tehran
Phone: 09127305773
Email: bahrami.s@iums.ac.ir

How to obtain:
The applicant can introduce himself / herself by e-mail and provide sufficient and documented reasons for receiving the study information.The research agent can check this information in a period of two weeks and if he is sure that the request is correct, he will send the requested items to the applicant

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sima Bahrami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrate Rasoole Akram hospital,Niayesh St,Satarkhan Av,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6435 1000</telephone>
        <email>bahrami.s@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sima Bahrami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Allergy and immunology clinic,Hazrate Rasoole Akram Hospital,Niayesh St,Satarkhan Av,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6435 1000</telephone>
        <email>bahrami.s@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with definitive diagnosis of COVID19 were hospitalized and treated
Patients with COVID19 who still have dyspena and cough two weeks after discharge from the hospital
Patients with COVID19 who continue to have lung involvement on CT SCAN two weeks after discharge</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with comorbidities such as chronic heart or lung disease before COVID19
The need for long-term use of drugs that have an irreversible interaction with the drugs used in the plan.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID19 ,virus identified</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Hydroxychloroquine tablets 200 mg every 12 hours for  one month fram Rooz daroo company</i_keyword>
      <i_keyword>Intervention group 2: Clarithromycin 500 mg capsules every 12 hours for one month from Tehran shimi company</i_keyword>
      <i_keyword>Control group: without receiving medication during a one-month follow-up</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dyspnea. Timepoint: Beginning of the study (before the intervention), 14, 30 days after the start of the study. Method of measurement: Medical Research Council(MRC).</prim_outcome>
      <prim_outcome>Cough. Timepoint: Beginning of the study (before the intervention), 14, 30 days after the start of the study. Method of measurement: visual analogue scale(vas).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lung function. Timepoint: At the beginning of the study (before the intervention) and 30 days later at the end of the study. Method of measurement: six minute walk test(6MW).</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>2020-07-04</approval_date>
        <contact_name>Ethics committee of Iran university of Medical Sciences</contact_name>
        <contact_address>Floor5,Headquarters,Iran university of Medical science,between Chamran and sheikh Fazlollah,Hemmat Highway,Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
