<?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>IRCT20210914052480N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-07</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>The efficacy of molnupiravir in patients with COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the efficacy of Molnupiravir and placebo on recovery rate in patients with mild COVID-19, a randomized multicenter clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>500</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60762</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the Block Randomization method will be used using blocks of four in random order. In this method, treatment blocks are moved back and forth randomly, for example, with a block of length 4 and with two treatment groups, there are the following possibilities
ABBB, ABAB, ABBA, BABA, BAAB, BBAA
  By putting these blocks together randomly, a balanced random list of two treatment groups is obtained, Blinding description: In this study, patients participating in the clinical trial and individuals collecting patient data will not be aware of the intervention groups. Mulnopiravir and placebo will be exactly the same, and no one will know the contents until the end of the study.</study_design>
      <phase>2-3</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The group receiving oral molnopiravir 200 mg daily for up to five days after the intervention, with diphenhydramine syrup / vitamin C tablet / vitamin D tablet / famotidine 40 mg tablet every 12 hours (in case of fever and pain Muscle naproxen 250 mg daily or twice daily will be added). Intervention 2: Control group: This group will receive placebo exactly similar to molnopiravir for five days, with diphenhydramine syrup, vitamin C tablets, vitamin D tablets, famotidine 40mg tablets every 12 hours, and naproxen 250 in case of fever and muscle aches. They will receive it once or twice a day.</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:
The data can be used by others without any personal information of patients

When:
after data gathering completion

To whom:
Only people with relevant permissions to use confidential information

Conditions:
The data can be used for statistical analysis and re-examination

Where to obtain:
Morteza Izadi; access through email: morteza_izadi@yahoo.com

How to obtain:
After calling or sending an email, the data will be sent if the applicant is valid

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Soleymanitabar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mollasadra street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8860 0067</telephone>
        <email>Asoleimanitabar21@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Morteza Izadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South Sheikh-e-Bahaei street; Mollasadra street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435912345</zip>
        <telephone>+98 21 8804 6515</telephone>
        <email>morteza_izadi@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Living in a family with at least one infected person with COVID-19
Not having pulmonary involvement
Not having symptoms like chest wall pain and dysnea suggesting pulmonary involvement
Positive PCR test of COVID-19
Patient with COVID-19 symptoms lesser than 3 days
Patients satisfied with consumption of oral medication
Blood oxygen saturation above 93 percents</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients under 18 years old
Having underlying diseases such as uncontrolled diabetes, uncontrolled blood pressure, liver and heart disease and kidney, heart and liver failure
History of any of the diseases including hepatitis B or C, HIV, autoimmune diseases and immunodeficiency
History of hepatocellular disease, liver failure and heart failure of liver tests more than 3 times normal
History of allergy to antiviral drugs
Existence of thrombocytopenia (platelets under 100000)
History of recent COVID-19 vaccination lesser than 7 days
being pregnant
breastfeeding</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus identified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The group receiving oral molnopiravir 200 mg daily for up to five days after the intervention, with diphenhydramine syrup / vitamin C tablet / vitamin D tablet / famotidine 40 mg tablet every 12 hours (in case of fever and pain Muscle naproxen 250 mg daily or twice daily will be added)</i_keyword>
      <i_keyword>Control group: This group will receive placebo exactly similar to molnopiravir for five days, with diphenhydramine syrup, vitamin C tablets, vitamin D tablets, famotidine 40mg tablets every 12 hours, and naproxen 250 in case of fever and muscle aches. They will receive it once or twice a day</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Negative pcr test or increase in CT NUMBER after intervention. Timepoint: Before and after the intervention. Method of measurement: According to the throat sample of patients with Covid-19, which is taken from patients in the same conditions in the specialized virology laboratory of Baqiyatallah Medical Center.</prim_outcome>
      <prim_outcome>Fever. Timepoint: Upon arrival and after five days. Method of measurement: with a standard thermometer.</prim_outcome>
      <prim_outcome>Serum CRP inflammatory factor. Timepoint: Upon arrival and after five days. Method of measurement: By a valid laboratory.</prim_outcome>
      <prim_outcome>The level of oxygen saturation in the blood of patients. Timepoint: Upon arrival and after five days. Method of measurement: By standard pulse oximeter.</prim_outcome>
      <prim_outcome>Dry cough existance. Timepoint: Upon arrival and after five days. Method of measurement: patient report and researcher observe.</prim_outcome>
      <prim_outcome>Dyspnea. Timepoint: Upon arrival and after five days. Method of measurement: patient report and researcher observe.</prim_outcome>
      <prim_outcome>Muscular pain. Timepoint: Upon arrival and after five days. Method of measurement: patient report and researcher observe.</prim_outcome>
      <prim_outcome>Pulse rate. Timepoint: Upon arrival and after five days. Method of measurement: researcher measure.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: Upon arrival and after five days. Method of measurement: researcher measure.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Upon arrival and after five days. Method of measurement: researcher measure.</prim_outcome>
      <prim_outcome>Serum ESR  inflammatory factor. Timepoint: Upon arrival and after five days. Method of measurement: By a valid laboratory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-20</approval_date>
        <contact_name>Ethics committee of Baqiyatallah University of Medical Sciences</contact_name>
        <contact_address>Research center; Baqiyatallah University of Medical Sciences; Sheikh-e-bahaei street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
