<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04408456</url>
  </required_header>
  <id_info>
    <org_study_id>IEC-04/2020-1624</org_study_id>
    <nct_id>NCT04408456</nct_id>
  </id_info>
  <brief_title>Efficacy of Hydroxychloroquine (HCQ) as Post Exposure Prophylaxis (PEP) for Prevention of COVID-19</brief_title>
  <acronym>PEP-CQ</acronym>
  <official_title>Efficacy of Hydroxychloroquine (HCQ) as Post Exposure Prophylaxis (PEP) for Prevention of COVID-19 in Asymptomatic Individual at Risk for SARS-CoV-2 Infection-A Open Level Control Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Postgraduate Institute of Medical Education and Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Postgraduate Institute of Medical Education and Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Novel corona virus (SARS-CoV-2) epidemic which stared from Wuhan in China is now a well&#xD;
      established pandemic worldwide. After Italy, Spain, Germany, United Kingdom and USA, India is&#xD;
      at the edge of becoming the next epicentre of this Pandemic. If adequate preventive and&#xD;
      therapeutic measures are not taken, India has very high risk of affecting million of people&#xD;
      with high mortality because of the large population along with very high population density.&#xD;
      At present there are no definitive therapeutic drugs or vaccine are available for the&#xD;
      treatment and prevention of SARS-CoV-2 infection. Symptomatic and supportive care are being&#xD;
      given to COVID-19 cases along with isolation and quarantine measure are being taken for the&#xD;
      suspected individual at risk for COVID-19 to limit the spread of the SARS-CoV-2 infection .&#xD;
      Among the all the drugs being used for the treatment of COVID-19, hydroxychloroquine (HCQ),&#xD;
      has given some rays of hope to battle against this deadly pandemic. HCQ has some anti viral&#xD;
      effect against SARS-CoV in vitro. HCQ is quite safe and being used in rheumatology patients&#xD;
      for lifelong without much side effect, so it allow for higher dose without any significant&#xD;
      side effects and drug-drug interaction. Recently published clinical trial suggested HCQ can&#xD;
      be used for the therapeutic purpose of the SARS-CoV-2 infection. Indian council of medical&#xD;
      research (ICMR) has advised for HCQ prophylaxis for all asymptomatic health care workers&#xD;
      involved in taking care of suspected or confirmed COVID-19 cases and all asymptomatic&#xD;
      household contacts of labarotory confirmed COVID-19 cases. But there is still lack of&#xD;
      significant scientific data to prove or disprove the efficacy of HCQ for the treatment and&#xD;
      post exposure chemo-prophylaxis for SARS-CoV-2 infection. Being a tertiary care centre we are&#xD;
      catering many states which include Punjab, hariyana, himachal Pradesh, Uttara khand, Uttar&#xD;
      Pradesh. Among this Punjab have highest population of non residential Indian (NRI) and most&#xD;
      of them have returned home. This put our institute to handle highest burden of suspected&#xD;
      cases of SARS-CoV-2 in northern India. So we have planned this open level control clinical&#xD;
      trial to evaluate the efficacy of post exposure prophylaxis (PEP) with HCQ for the prevention&#xD;
      of COVID-19 in asymptomatic individuals who are at risk for SARS-CoV-2 infection. All&#xD;
      asymptomatic individuals who have undertaken international travel in last 2 weeks and all&#xD;
      asymptomatic individual with direct contact with laboratory confirmed cases will be advised&#xD;
      for home quarantine for 2 weeks along with social distancing and personal hygiene. They will&#xD;
      be given the option for taking HCQ prophylaxis. These quarantined asymptomatic individuals&#xD;
      will be assigned into one post exposure prophylaxis (PEP) group and one control group as per&#xD;
      inclusion and exclusion criteria. Individual who will not give consent for HCQ prophylaxis&#xD;
      and those with contraindication for HCQ therapy like, hypersensitivity to HCQ or&#xD;
      4-aminoquinolone derivatives, patients with known retionopathy, cardiac arrhythmia, G6PD&#xD;
      deficiency, psoriasis and pregnancy will be directly included in the control group. All&#xD;
      symptomatic individual, and all health care workers related to suspected or proven COVID-19&#xD;
      will be excluded from the study. The PEP group will receive tablet HCQ 400 mg q 12 hourly on&#xD;
      day one followed by 400 mg once weekly for 3 weeks (total cumulative dose of 2000 mg). The&#xD;
      control group will not receive HCQ. Both the groups will receive standard care of therapy in&#xD;
      the form of home quarantine for 2 weeks along with social distancing and personal hygiene.&#xD;
      They will be followed up for 4 weeks telephonically or physically as and when required and&#xD;
      will be enquired regarding development of any COVID-19 symptoms like fever, cough, sore&#xD;
      throat, shortness of breath, diarrhoea, myalgia.During follow up nasopharyngeal and or throat&#xD;
      swab of the participants will be taken for processing reverse transcription polymerase chain&#xD;
      reaction (RTPCR) for the detection SARS-Cov-2 RNA to confirm CoVID-19. Samples for RTPCR will&#xD;
      be taken when any asymptomatic participants become symptomatic and by the 5-14 days of&#xD;
      contact in asymptomatic participants through in-hospital visit at the institute's&#xD;
      communicable disease ward isolation. The participant with RTPCR positive and with or without&#xD;
      symptoms will be defined as definite COVID-19 case and the RTPCR negative symptomatic&#xD;
      participant will be defined as probable COVID-19 case. Asymptomatic participants with&#xD;
      negative RTPCR will be defined as non-COVID case. Incidence of COVID-19 or probable COVID-19&#xD;
      or non-COVID case in previously asymptomatic participants will be compared between the PEP&#xD;
      and control groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background and rational of the study:&#xD;
&#xD;
      Novel corona virus (SARS-CoV-2) epidemic which stared from Wuhan in China is now a well&#xD;
      established pandemic worldwide affecting more than 3 lakh people with more than 15000&#xD;
      mortality. As Italy, Spain, Germany, United Kingdom and USA have taken over from China in&#xD;
      term of highest burden of mortality, India is at the edge of becoming the next epicentre of&#xD;
      this Pandemic. Presently there are around 500 active cases of corona virus disease-19&#xD;
      (COVID-19) in India with unfortunate mortality of 8 patients as on 24th March 2020. The&#xD;
      clinical presentation of the COVID-19 varies from asymptomatic cases and mild symptoms of&#xD;
      fever, cough, sore throat, headache, myalgia, nasal congestion, diarrhea to severe pneumonia,&#xD;
      acute respiratory distress syndrome (ARDS) requiring mechanical ventilation and even&#xD;
      multi-organ dysfunction syndrome (MODS), sepsis leading to death. If adequate preventive and&#xD;
      therapeutic measures are not taken, India has very high risk of affecting million of people&#xD;
      with high mortality because of the large population along with very high population density.&#xD;
      At present there are no definitive therapeutic drugs or vaccine are available for the&#xD;
      treatment and prevention of SARS-CoV-2 infection. Symptomatic and supportive care are being&#xD;
      given to COVID-19 cases along with isolation and quarantine measure are being taken for the&#xD;
      suspected individual at risk for COVID-19 to limit the spread of the SARS-CoV-2 infection.&#xD;
&#xD;
      Presently many scientist and doctors are recommending many existing available drugs&#xD;
      (Ribavirin, lopinavir, Remdesivir, chloroquine, hydroxychloroquine) for SARS-CoV-2 infection&#xD;
      for therapeutic and as well as prophylactic purpose . Among which hydroxychloroquine sulphate&#xD;
      (HCQ), a chloroquine analogue has given some rays of hope to battle against this deadly&#xD;
      pandemic. In a in vitro study researchers have found that HCQ has some anti viral effect&#xD;
      against SARS-CoV through mechanism targeted at the host cell. HCQ is quite safe drugs as it&#xD;
      is being used in rheumatology patients for lifelong therapy without much side effect, so it&#xD;
      allow for higher dose without any significant side effects and drug-drug interaction.&#xD;
      Recently published clinical trial suggested HCQ can be used for the therapeutic purpose of&#xD;
      the SARS-CoV-2 infection and many governments including USA and India have already endorse&#xD;
      that due to lack of any other better alternative drugs. ICMR has advised for HCQ prophylaxis&#xD;
      for the people who are at risk for developing SARS-CoV-2 infection, all asymptomatic health&#xD;
      care workers involved in taking care of suspected or confirmed COVID-19 cases and all&#xD;
      asymptomatic household contacts of labarotory confirmed COVID-19 cases. But there is still&#xD;
      lack of significant scientific data to prove or disprove the efficacy of HCQ for the&#xD;
      treatment and post exposure chemo-prophylaxis for SARS-CoV-2 infection management. Being a&#xD;
      tertiary care centre we are catering many states which include Punjab, hariyana, himachal&#xD;
      Pradesh, Uttara khand, Uttar Pradesh. Among this Punjab have highest population of non&#xD;
      residential Indian (NRI) and most of them have returned home. This put our institute to&#xD;
      handle highest burden of suspected cases of SARS-CoV-2 in northern India. So we have planned&#xD;
      this randomised control clinical trial to evaluate the efficacy of post exposure prophylaxis&#xD;
      (PEP) with HCQ for the prevention of COVID-19 in asymptomatic population who are at risk for&#xD;
      SARS-CoV-2 infection. As a research institute of national as well as international interest,&#xD;
      it is a great opportunity for us to produce such a robust data which can be utilized in&#xD;
      reforming national and international guidelines for the battle against of COVID-19 pandemic.&#xD;
&#xD;
      Details of method:&#xD;
&#xD;
      Aims of the study: To evaluate the efficacy of post exposure prophylaxis (PEP) with HCQ for&#xD;
      the prevention of COVID-19 in asymptomatic individual who are at risk for SARS-CoV-2&#xD;
      infection.&#xD;
&#xD;
      Site of Study: The study will be conducted in the special screening OPD for the SARS-CoV-2 at&#xD;
      Emergency and medical outpatient department (EMOPD &amp; MOPD) and Communicable disease ward of&#xD;
      the Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.&#xD;
      The study will be done under the collaboration of the department of Internal Medicine,&#xD;
      Virology and Pharmacology of the institute, PGIMER,Chandigarh.&#xD;
&#xD;
      Study Design: It is an open label controlled clinical trial. The study will be done in two&#xD;
      groups. After screening of the suspected SARS-CoV-2 infected individuals, asymptomatic&#xD;
      quarantined individuals will be assigned into two study groups. Post exposure prophylaxis&#xD;
      (PPE) group will receive tablet HCQ 400 mg q 12 hourly on day one followed by 400 mg once&#xD;
      weekly for 3 weeks (total cumulative dose of 2000 mg). The control group will not receive&#xD;
      HCQ. Both the groups will receive standard care of therapy. Individual who will not give&#xD;
      consent for HCQ prophylaxis and those with contraindication for HCQ therapy will be directly&#xD;
      included in the control group. They will be followed up for 4 weeks telephonically or&#xD;
      physically as and when required.&#xD;
&#xD;
      Screening and Enrolment of Patients: All the suspected cases of COVID-19 will be screened as&#xD;
      per ICMR guideline at special screening OPD for the SARS-CoV-2 at Emergency and medical&#xD;
      outpatient department (EMOPD &amp; MOPD. All asymptomatic individuals who have undertaken&#xD;
      international travel in last 2 weeks and all asymptomatic individual with direct contact with&#xD;
      laboratory confirmed cases will be advised for home quarantine for 2 weeks along with social&#xD;
      distancing and personal hygiene. They will be given the option for taking HCQ prophylaxis.&#xD;
      They will be assigned into one post exposure prophylaxis (PEP) group and one control croup as&#xD;
      per inclusion and exclusion criteria after getting informed consent.Individual who will not&#xD;
      give consent for HCQ prophylaxis and patients with contraindication for HCQ therapy like,&#xD;
      hypersensitivity to HCQ or 4-aminoquinolone derivatives, patients with known retionopathy,&#xD;
      cardiac arrhythmia, G6PD deficiency, psoriasis and pregnancy will be directly included in the&#xD;
      control groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Actual">July 31, 2020</completion_date>
  <primary_completion_date type="Actual">July 31, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence confirmed case of COVID-19</measure>
    <time_frame>3 weeks</time_frame>
    <description>Participant with RTPCR positive for SARS-CoV-2 and with or without symptoms will be defined as definite COVID-19 case.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of probable case of COVID-19</measure>
    <time_frame>3 weeks</time_frame>
    <description>The participant with new onset symptoms, but RTPCR negative for SARS-CoV-2 or could not be performed for any reason will be defined as probable COVID-19 case.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse drug reaction (ADR)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Any adverse reaction related to Hydroxychloroquine</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">325</enrollment>
  <condition>CoVID-19</condition>
  <arm_group>
    <arm_group_label>Post Exposure Prophylaxis (PEP) Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard therapy in the form of home quarantine for 2 weeks along with social distancing and personal hygiene Plus Tablet HCQ 400 mg q 12 hourly on day one followed by 400 mg once weekly for 3 weeks (total cumulative dose of 2000 mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard therapy in the form of home quarantine for 2 weeks along with social distancing and personal hygiene</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HCQ</intervention_name>
    <description>Tablet HCQ 400 mg q 12 hourly on day one followed by 400 mg once weekly for 3 weeks (total cumulative dose of 2000 mg)</description>
    <arm_group_label>Post Exposure Prophylaxis (PEP) Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard therapy</intervention_name>
    <description>Home quarantine for 2 weeks plus social distancing plus personal hygiene</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Post Exposure Prophylaxis (PEP) Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          1. Asymptomatic individuals who have undertaken International travel in last 2 weeks&#xD;
&#xD;
          2. Asymptomatic individual with direct contact with laboratory confirmed cases&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          1. Symptomatic individual&#xD;
&#xD;
          2. Health care worker&#xD;
&#xD;
        Individual who will not give consent for HCQ prophylaxis and patients with contraindication&#xD;
        for HCQ therapy like, hypersensitivity to HCQ or 4-aminoquinolone derivatives, patients&#xD;
        with known retionopathy, cardiac arrhythmia, G6PD deficiency, psoriasis and pregnancy will&#xD;
        be directly included in the control groups.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deba P Dhibar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>PGIMER, Chandigarh, India</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Post Graduate Institute of Medical Education and Research (PGIMER)</name>
      <address>
        <city>Chandigarh</city>
        <zip>160012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Post Graduate Institute of Medical Education and Research</name>
      <address>
        <city>Chandigarh</city>
        <zip>160012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>August 1, 2020</last_update_submitted>
  <last_update_submitted_qc>August 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Postgraduate Institute of Medical Education and Research</investigator_affiliation>
    <investigator_full_name>Deba Prasad Dhibar</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>CoVID-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Hydroxychloroquine (HCQ)</keyword>
  <keyword>post exposure prophylaxis (PEP)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will be shared with the concerned authority and Institutional Ethics committee as and when required.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04408456
org study id: IEC-04/2020-1624
nct id: NCT04408456
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Novel corona virus (SARS-CoV-2) epidemic which stared from Wuhan in China is now a well
      established pandemic worldwide. After Italy, Spain, Germany, United Kingdom and USA, India is
      at the edge of becoming the next epicentre of this Pandemic. If adequate preventive and
      therapeutic measures are not taken, India has very high risk of affecting million of people
      with high mortality because of the large population along with very high population density.
      At present there are no definitive therapeutic drugs or vaccine are available for the
      treatment and prevention of SARS-CoV-2 infection. Symptomatic and supportive care are being
      given to COVID-19 cases along with isolation and quarantine measure are being taken for the
      suspected individual at risk for COVID-19 to limit the spread of the SARS-CoV-2 infection .
      Among the all the drugs being used for the treatment of COVID-19, hydroxychloroquine (HCQ),
      has given some rays of hope to battle against this deadly pandemic. HCQ has some anti viral
      effect against SARS-CoV in vitro. HCQ is quite safe and being used in rheumatology patients
      for lifelong without much side effect, so it allow for higher dose without any significant
      side effects and drug-drug interaction. Recently published clinical trial suggested HCQ can
      be used for the therapeutic purpose of the SARS-CoV-2 infection. Indian council of medical
      research (ICMR) has advised for HCQ prophylaxis for all asymptomatic health care workers
      involved in taking care of suspected or confirmed COVID-19 cases and all asymptomatic
      household contacts of labarotory confirmed COVID-19 cases. But there is still lack of
      significant scientific data to prove or disprove the efficacy of HCQ for the treatment and
      post exposure chemo-prophylaxis for SARS-CoV-2 infection. Being a tertiary care centre we are
      catering many states which include Punjab, hariyana, himachal Pradesh, Uttara khand, Uttar
      Pradesh. Among this Punjab have highest population of non residential Indian (NRI) and most
      of them have returned home. This put our institute to handle highest burden of suspected
      cases of SARS-CoV-2 in northern India. So we have planned this open level control clinical
      trial to evaluate the efficacy of post exposure prophylaxis (PEP) with HCQ for the prevention
      of COVID-19 in asymptomatic individuals who are at risk for SARS-CoV-2 infection. All
      asymptomatic individuals who have undertaken international travel in last 2 weeks and all
      asymptomatic individual with direct contact with laboratory confirmed cases will be advised
      for home quarantine for 2 weeks along with social distancing and personal hygiene. They will
      be given the option for taking HCQ prophylaxis. These quarantined asymptomatic individuals
      will be assigned into one post exposure prophylaxis (PEP) group and one control group as per
      inclusion and exclusion criteria. Individual who will not give consent for HCQ prophylaxis
      and those with contraindication for HCQ therapy like, hypersensitivity to HCQ or
      4-aminoquinolone derivatives, patients with known retionopathy, cardiac arrhythmia, G6PD
      deficiency, psoriasis and pregnancy will be directly included in the control group. All
      symptomatic individual, and all health care workers related to suspected or proven COVID-19
      will be excluded from the study. The PEP group will receive tablet HCQ 400 mg q 12 hourly on
      day one followed by 400 mg once weekly for 3 weeks (total cumulative dose of 2000 mg). The
      control group will not receive HCQ. Both the groups will receive standard care of therapy in
      the form of home quarantine for 2 weeks along with social distancing and personal hygiene.
      They will be followed up for 4 weeks telephonically or physically as and when required and
      will be enquired regarding development of any COVID-19 symptoms like fever, cough, sore
      throat, shortness of breath, diarrhoea, myalgia.During follow up nasopharyngeal and or throat
      swab of the participants will be taken for processing reverse transcription polymerase chain
      reaction (RTPCR) for the detection SARS-Cov-2 RNA to confirm CoVID-19. Samples for RTPCR will
      be taken when any asymptomatic participants become symptomatic and by the 5-14 days of
      contact in asymptomatic participants through in-hospital visit at the institute's
      communicable disease ward isolation. The participant with RTPCR positive and with or without
      symptoms will be defined as definite COVID-19 case and the RTPCR negative symptomatic
      participant will be defined as probable COVID-19 case. Asymptomatic participants with
      negative RTPCR will be defined as non-COVID case. Incidence of COVID-19 or probable COVID-19
      or non-COVID case in previously asymptomatic participants will be compared between the PEP
      and control groups.
Background and rational of the study:

      Novel corona virus (SARS-CoV-2) epidemic which stared from Wuhan in China is now a well
      established pandemic worldwide affecting more than 3 lakh people with more than 15000
      mortality. As Italy, Spain, Germany, United Kingdom and USA have taken over from China in
      term of highest burden of mortality, India is at the edge of becoming the next epicentre of
      this Pandemic. Presently there are around 500 active cases of corona virus disease-19
      (COVID-19) in India with unfortunate mortality of 8 patients as on 24th March 2020. The
      clinical presentation of the COVID-19 varies from asymptomatic cases and mild symptoms of
      fever, cough, sore throat, headache, myalgia, nasal congestion, diarrhea to severe pneumonia,
      acute respiratory distress syndrome (ARDS) requiring mechanical ventilation and even
      multi-organ dysfunction syndrome (MODS), sepsis leading to death. If adequate preventive and
      therapeutic measures are not taken, India has very high risk of affecting million of people
      with high mortality because of the large population along with very high population density.
      At present there are no definitive therapeutic drugs or vaccine are available for the
      treatment and prevention of SARS-CoV-2 infection. Symptomatic and supportive care are being
      given to COVID-19 cases along with isolation and quarantine measure are being taken for the
      suspected individual at risk for COVID-19 to limit the spread of the SARS-CoV-2 infection.

      Presently many scientist and doctors are recommending many existing available drugs
      (Ribavirin, lopinavir, Remdesivir, chloroquine, hydroxychloroquine) for SARS-CoV-2 infection
      for therapeutic and as well as prophylactic purpose . Among which hydroxychloroquine sulphate
      (HCQ), a chloroquine analogue has given some rays of hope to battle against this deadly
      pandemic. In a in vitro study researchers have found that HCQ has some anti viral effect
      against SARS-CoV through mechanism targeted at the host cell. HCQ is quite safe drugs as it
      is being used in rheumatology patients for lifelong therapy without much side effect, so it
      allow for higher dose without any significant side effects and drug-drug interaction.
      Recently published clinical trial suggested HCQ can be used for the therapeutic purpose of
      the SARS-CoV-2 infection and many governments including USA and India have already endorse
      that due to lack of any other better alternative drugs. ICMR has advised for HCQ prophylaxis
      for the people who are at risk for developing SARS-CoV-2 infection, all asymptomatic health
      care workers involved in taking care of suspected or confirmed COVID-19 cases and all
      asymptomatic household contacts of labarotory confirmed COVID-19 cases. But there is still
      lack of significant scientific data to prove or disprove the efficacy of HCQ for the
      treatment and post exposure chemo-prophylaxis for SARS-CoV-2 infection management. Being a
      tertiary care centre we are catering many states which include Punjab, hariyana, himachal
      Pradesh, Uttara khand, Uttar Pradesh. Among this Punjab have highest population of non
      residential Indian (NRI) and most of them have returned home. This put our institute to
      handle highest burden of suspected cases of SARS-CoV-2 in northern India. So we have planned
      this randomised control clinical trial to evaluate the efficacy of post exposure prophylaxis
      (PEP) with HCQ for the prevention of COVID-19 in asymptomatic population who are at risk for
      SARS-CoV-2 infection. As a research institute of national as well as international interest,
      it is a great opportunity for us to produce such a robust data which can be utilized in
      reforming national and international guidelines for the battle against of COVID-19 pandemic.

      Details of method:

      Aims of the study: To evaluate the efficacy of post exposure prophylaxis (PEP) with HCQ for
      the prevention of COVID-19 in asymptomatic individual who are at risk for SARS-CoV-2
      infection.

      Site of Study: The study will be conducted in the special screening OPD for the SARS-CoV-2 at
      Emergency and medical outpatient department (EMOPD & MOPD) and Communicable disease ward of
      the Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
      The study will be done under the collaboration of the department of Internal Medicine,
      Virology and Pharmacology of the institute, PGIMER,Chandigarh.

      Study Design: It is an open label controlled clinical trial. The study will be done in two
      groups. After screening of the suspected SARS-CoV-2 infected individuals, asymptomatic
      quarantined individuals will be assigned into two study groups. Post exposure prophylaxis
      (PPE) group will receive tablet HCQ 400 mg q 12 hourly on day one followed by 400 mg once
      weekly for 3 weeks (total cumulative dose of 2000 mg). The control group will not receive
      HCQ. Both the groups will receive standard care of therapy. Individual who will not give
      consent for HCQ prophylaxis and those with contraindication for HCQ therapy will be directly
      included in the control group. They will be followed up for 4 weeks telephonically or
      physically as and when required.

      Screening and Enrolment of Patients: All the suspected cases of COVID-19 will be screened as
      per ICMR guideline at special screening OPD for the SARS-CoV-2 at Emergency and medical
      outpatient department (EMOPD & MOPD. All asymptomatic individuals who have undertaken
      international travel in last 2 weeks and all asymptomatic individual with direct contact with
      laboratory confirmed cases will be advised for home quarantine for 2 weeks along with social
      distancing and personal hygiene. They will be given the option for taking HCQ prophylaxis.
      They will be assigned into one post exposure prophylaxis (PEP) group and one control croup as
      per inclusion and exclusion criteria after getting informed consent.Individual who will not
      give consent for HCQ prophylaxis and patients with contraindication for HCQ therapy like,
      hypersensitivity to HCQ or 4-aminoquinolone derivatives, patients with known retionopathy,
      cardiac arrhythmia, G6PD deficiency, psoriasis and pregnancy will be directly included in the
      control groups.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence confirmed case of COVID-19
time frame: 3 weeks
description: Participant with RTPCR positive for SARS-CoV-2 and with or without symptoms will be defined as definite COVID-19 case.
measure: Incidence of probable case of COVID-19
time frame: 3 weeks
description: The participant with new onset symptoms, but RTPCR negative for SARS-CoV-2 or could not be performed for any reason will be defined as probable COVID-19 case.
measure: Incidence of adverse drug reaction (ADR)
time frame: 4 weeks
description: Any adverse reaction related to Hydroxychloroquine
arm group label: Post Exposure Prophylaxis (PEP) Group
arm group type: Active Comparator
description: Standard therapy in the form of home quarantine for 2 weeks along with social distancing and personal hygiene Plus Tablet HCQ 400 mg q 12 hourly on day one followed by 400 mg once weekly for 3 weeks (total cumulative dose of 2000 mg)
arm group label: Control Group
arm group type: Other
description: Standard therapy in the form of home quarantine for 2 weeks along with social distancing and personal hygiene
intervention type: Drug
intervention name: HCQ
description: Tablet HCQ 400 mg q 12 hourly on day one followed by 400 mg once weekly for 3 weeks (total cumulative dose of 2000 mg)
arm group label: Post Exposure Prophylaxis (PEP) Group
intervention type: Other
intervention name: Standard therapy
description: Home quarantine for 2 weeks plus social distancing plus personal hygiene
arm group label: Control Group
arm group label: Post Exposure Prophylaxis (PEP) Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Deba P Dhibar, MD
role: Principal Investigator
affiliation: PGIMER, Chandigarh, India
facility: 
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Postgraduate Institute of Medical Education and Research
investigator full name: Deba Prasad Dhibar
investigator title: Assistant Professor
mesh term: COVID-19
sharing ipd: No
ipd description: Data will be shared with the concerned authority and Institutional Ethics committee as and when required.