<?xml version="1.0" encoding="UTF-8"?>
<trials>
  <trial>
    <main>
      <trial_id/>
      <utrn/>
      <reg_name/>
      <date_registration/>
      <primary_sponsor>ASSOCIACAO BRASILEIRA DE OZONIOTERAPIA</primary_sponsor>
      <public_title>ESTUDO MULTICENTRICO DA PR?TICA INTEGRATIVA E COMPLEMENTAR DE OZONIOTERAPIA EM PACIENTES AMBULATORIAIS COM COVID 19</public_title>
      <acronym>ERAPT</acronym>
      <scientific_title>ESTUDO MULTICENTRICO DA PR?TICA INTEGRATIVA E COMPLEMENTAR DE OZONIOTERAPIA EM PACIENTES AMBULATORIAIS COM COVID 19</scientific_title>
      <scientific_acronym>ERAPT</scientific_acronym>
      <date_enrolment/>
      <type_enrolment/>
      <target_size>142</target_size>
      <recruitment_status>Not yet recrutment</recruitment_status>
      <url>http://ec.teste.bvsalud.org/rg/RBR-294d68/</url>
      <study_type>Interven??o/Experimental</study_type>
      <study_design/>
      <phase/>
      <hc_freetext>S?ndrome respirat?ria aguda grave (Severe acute respiratory syndrome) [SARS], n?o especificada/ozonioterapia </hc_freetext>
      <i_freetext>S?ndrome respirat?ria aguda grave (Severe acute respiratory syndrome) [SARS], n?o especificada/ozonioterapia </i_freetext>
    </main>
    <contacts>
      <contact>
        <type>scientific</type>
        <firstname>ARNOLDO</firstname>
        <middlename>DE</middlename>
        <lastname>SOUZA</lastname>
        <address>RIBEIRO JUNQUEIRA,68</address>
        <country1>BRASIL</country1>
        <zip>35010230</zip>
        <telephone>3332712017</telephone>
        <email>arnoldos@cardiol.br</email>
        <affiliation>ASSOCIACAO BRASILEIRA DE OZONIOTERAPIA</affiliation>
      </contact>
      <contact>
        <type>public</type>
        <firstname>ARNOLDO</firstname>
        <middlename>DE</middlename>
        <lastname>SOUZA</lastname>
        <address>RIBEIRO JUNQUEIRA,68</address>
        <country1>BRASIL</country1>
        <zip>35010230</zip>
        <telephone>3332712017</telephone>
        <email>arnoldos@cardiol.br</email>
        <affiliation>National Diabetes Association</affiliation>
      </contact>
    </contacts>
    <countries>
      <country>BRASIL</country>
    </countries>
    <criteria>
      <inclusion_criteria>Ambos sexos;&#x0D;Idade entre 18 e 90 anos; &#x0D;Assinatura do termo de consentimento livre e esclarecido (TCLE).&#x0D;Sorologia positiva para COVID 19 (PCR por Swab) </inclusion_criteria>
      <agemin/>
      <agemax/>
      <gender/>
      <exclusion_criteria>Gravidez, especialmente no in?cio;&#x0D;Indiv?duos que usem, continuamente, imunossupressores ou transplantados h? menos de 6 meses;&#x0D;Indiv?duos que estejam participando de outros estudos cl?nicos.&#x0D;Sintomas de s?ndrome respirat?ria aguda graves (SRAG) e/ou com comorbidades de acordo com as normativas do Minist?rio da Saude ( Diretrizes para Diagn?stico e Tratamento para COVID-19, vers?o 1 de 06 de abril de 2020), com suspeita de COVID 19, com RT-PCR Covid -19&#x0D;</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code/>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword/>
    </health_condition_keyword>
    <intervention_code>
      <i_code/>
    </intervention_code>
    <intervention_keyword>
      <i_keyword/>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Redu??o do percentual de pacientes com suspeita/confirmados de COVID 19 que evoluem para formas mais graves (necessidade de interna??o e/ou ventila??o mecanica) com aumento da taxa de recupera??o desses pacientes do grupo que fizeram ozonioterapia.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Redu??o do tempo de sintomas  e redu??o da carga viral pelo COVID 19 e suas consequencias.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name/>
    </secondary_sponsor>
    <secondary_ids/>
    <source_support>
      <source_name/>
    </source_support>
  </trial>
</trials>