<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/NCT04437693</url>
  </required_header>
  <id_info>
    <org_study_id>MRC-02-20-442</org_study_id>
    <nct_id>NCT04437693</nct_id>
  </id_info>
  <brief_title>Post Exposure Prophylaxis in Healthcare Workers Exposed to COVID-19 Patients</brief_title>
  <acronym>HCQ-COVID19</acronym>
  <official_title>Post Exposure Prophylaxis (PEP) in Healthcare Workers Exposed to COVID-19 Patients: A Double-blind Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hamad Medical Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hamad Medical Corporation</source>
  <oversight_info>
    <has_dmc>Yes</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>
      More cases of COVID-19 pandemic are being reported daily around the world. It is highly&#xD;
      infectious and, over 7 million people have been infected and more than 400,000 people have&#xD;
      died globally till this date. Countries around the world are struggling to avoid the spread&#xD;
      of this pandemic.&#xD;
&#xD;
      Center for Disease Control and Prevention (CDC) confirmed that there are no approved drugs&#xD;
      for COVID-19 treatment. Researchers around the globe, however, are researching different&#xD;
      medications for COVID-19 patients, including the drug Hydroxychloroquine (HCQ), which is&#xD;
      mainly used for Rheumatoid Arthritis and Malaria. Not enough data was obtained yet to know&#xD;
      how well all of these medications are functioning. Therefore, aim to perform a randomized&#xD;
      placebo-controlled trial to assess the impact of these medications on COVID -19 healthcare&#xD;
      workers exposed while treating COVID 19 patients in Qatar to avoid causality and&#xD;
      comorbidities in healthcare workers.&#xD;
&#xD;
      It is considered as a weak base. Many viruses enter the host cells via endocytosis, as a&#xD;
      result of which they are initially taken up into an intracellular compartment that is&#xD;
      &quot;typically fairly acidic&quot; whereas; Hydroxychloroquine would alter the acidity of this&#xD;
      compartment, which can interfere with the ability of viruses to escape into the host cell and&#xD;
      start replicating. Another hypothesis on the rationale of the Antiviral activity of HCQ, is&#xD;
      that HCQ may also alter the ability of the virus to bind to the outside of a host cell in the&#xD;
      first place.&#xD;
&#xD;
      An interventional, double-blind, placebo-controlled randomized trial that will include&#xD;
      participants who will be healthcare workers at risks of exposure to COVID-19 while managing&#xD;
      patients with confirmed infection.&#xD;
&#xD;
      Study will compare the safety, efficacy and effectiveness of Post Exposure Prophylaxis (PEP)&#xD;
      use of HCQ in healthcare workers at risk of exposure to COVID-19 patients, in comparison to&#xD;
      Placebo in Qatar.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      More cases of COVID-19 pandemic are being reported daily around the world. It is highly&#xD;
      infectious and, over 7 million people have been infected and more than 400,000 people have&#xD;
      died globally till this date. Countries around the world are struggling to avoid the spread&#xD;
      of this pandemic. The most common symptoms of coronavirus disease are fever, fatigue, and dry&#xD;
      cough. Most people (approximately 80 percent) recover from the disease without special care.&#xD;
      The disease can be serious, and even fatal. Older people, and people with other medical&#xD;
      conditions (such as asthma, diabetes, or heart disease), maybe more vulnerable to becoming&#xD;
      severely ill. As the COVID-19 pandemic continues to affect communities throughout the world,&#xD;
      the search for effective drugs remains a priority. Scientists across the globe are working to&#xD;
      produce a vaccine, but unlikely to be available before 2021. Meanwhile, a growing number of&#xD;
      countries have taken a series of systematic measures to curb coronavirus spread, including&#xD;
      national lockdowns, meeting bans, school closings, closures of restaurants, bars, sports&#xD;
      clubs etc&#xD;
&#xD;
      Researchers used to evaluate the invitro effectiveness of several potential COVID-19&#xD;
      treatments, including chloroquine (CQ) and redmeveir (RDV). The findings were found&#xD;
      encouraging as 90 percent of the virus was inhibited by a low concentration of CQ and the&#xD;
      results for RDV were even better-with an even lower concentration of this drug, achieving a&#xD;
      virus inhibition of 90 percent. However, unless clinically verified, it cannot confirm these&#xD;
      drugs for the treatment of COVID-19 patients. It is not known how well these medications&#xD;
      function in people who are infected with COVID-19 and is still being studied. The first&#xD;
      patient reported to be infected with COVID -19 in the U.S. was treated with RDV. The&#xD;
      treatment started on the 7th day of hospitalization and on the 11th day after his symptoms&#xD;
      were first identified. He started showing signs of progress on the very next day, presumably&#xD;
      due to treatment with RDV. Further data, however, is required to confirm the effect of this&#xD;
      treatment.&#xD;
&#xD;
      Researchers in France have also been studying the effectiveness of hydroxychloroquine (HCQ)&#xD;
      in a single-arm regimen to treat people with COVID-19. HCQ (and, in some cases, also&#xD;
      antibiotic azithromycin) has been used in this study to treat individuals with the COVID-19&#xD;
      virus in one setting. Investigators measured the amount of virus in swabs taken from these&#xD;
      individuals and from a group of individuals who did not receive HCQ. A larger decrease in the&#xD;
      volume of the virus from the individuals receiving HCQ occurred on a span of six days.&#xD;
      However, the groups were not randomized. Individuals who did not receive HCQ were at various&#xD;
      medical facilities and not necessarily like the individuals in the HCQ group. The results are&#xD;
      intriguing. But it's important to note that scientists have expressed concerns about this&#xD;
      study. Indeed, after the publication of these findings, a statement has been released in the&#xD;
      journal that it did not meet the &quot;expected standard&quot; of research (6).&#xD;
&#xD;
      Moreover, these two drugs HCQ and RDV were designed primarily to fight other diseases and not&#xD;
      COVID-19. Few data are available indicating that either could have some interest in the&#xD;
      treatment of the disease, but its complete effect on COVID-19 patients is not known. One&#xD;
      reason why researchers are interested in this drug is the HCQ's ability to modulate the&#xD;
      inflammatory response. Inflammation is the natural reaction of the body to bacteria, viruses,&#xD;
      or other substances that attack it. Our immune system usually attacks and actively kills&#xD;
      infected cells or foreign bodies. But this response may often fail to function properly&#xD;
      particularly in autoimmune disorders where the body is mistakenly attacking itself. HCQ has&#xD;
      subtle effects on a wide variety of immune cells, and it may be that one of these effects&#xD;
      helps stimulate the body's ability to fight off Covid-19. The inflammatory response in&#xD;
      COVID-19 can be so strong that it causes serious damage to the lungs, that is why patients&#xD;
      with severe infections need ventilators&#xD;
&#xD;
      Another hypothesis on the rationale of the Antiviral activity of HCQ, is that HCQ may also&#xD;
      alter the ability of the virus to bind to the outside of a host cell in the first place.&#xD;
&#xD;
      The gold standard of a drug trial is a placebo-controlled, randomized, double-blind study.&#xD;
      One group of participants should receive the investigational drug and another group should&#xD;
      receive a placebo. The individuals in each arm of the study should be randomized; the&#xD;
      demographics of both groups should be similar. Finally, the participants should not know if&#xD;
      they are receiving the investigational drug or a placebo and the healthcare workers should&#xD;
      not know what they are administering. Only under these conditions, It can conclusively&#xD;
      determine the safety and efficacy of a potential treatment.&#xD;
&#xD;
      Center for Disease Control and Prevention (CDC) confirmed that there are no approved drugs&#xD;
      for COVID-19 treatment. Researchers around the globe, however, are researching different&#xD;
      medications for COVID-19 patients, including the drug Hydroxychloroquine, which is mainly&#xD;
      used for the treatment of Rheumatoid Arthritis and Malaria. Not enough data was obtained yet&#xD;
      to know how well all of these medications are functioning. Therefore, aim to perform a&#xD;
      randomized placebo-controlled trial to assess the impact of these medications on healthcare&#xD;
      workers who exposed for the treatment of COVID -19 patients in Qatar.&#xD;
&#xD;
      Rational to conduct a clinical trial on HCQ: It is considered as a weak base. Many viruses&#xD;
      enter the host cells via endocytosis, as a result of which they are initially taken up into&#xD;
      an intracellular compartment that is &quot;typically fairly acidic&quot; whereas; Hydroxychloroquine&#xD;
      would alter the acidity of this compartment, which can interfere with the ability of viruses&#xD;
      to escape into the host cell and start replicating. Another hypothesis on the rationale of&#xD;
      the Antiviral activity of HCQ, is that HCQ may also alter the ability of the virus to bind to&#xD;
      the outside of a host cell in the first place.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      HCQ will be more safe and effective in comparison to placebo in the prevention of COVID 19&#xD;
      cases, in healthcare workers exposed to COVID 19 patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 31, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>An interventional, double-blind, placebo-controlled randomized trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The process of keeping the study group assignment hidden after allocation will be used where the investigator and participants will be unaware of the drug.A double blind randomized clinical trial has been proposed having 250 subjects in each arm. 500 subjects will be selected using randomly permuted blocks of 2,4, and 8 for the random process to allocate subjects into the two groups equally by using computer software.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Prevention of SARS-CoV-2 infection</measure>
    <time_frame>7 Months</time_frame>
    <description>Prevention of SARS-CoV-2 infection as determined by negative RT-PCR of the participants in the treatment group through swabbing that will be conducted on a weekly basis (Swabbing will be conducted at baseline and weekly through the end of the treatment period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of any adverse effects related to HCQ</measure>
    <time_frame>7 months</time_frame>
    <description>To find out the adverse effects related to HCQ such as : skin rashes, especially those made worse by sunlight, feeling sick (nausea) or indigestion, diarrhea, headaches, bleaching of the hair or mild hair loss, tinnitus (ringing in the ears) visual problem</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of COVID-19 related symptoms</measure>
    <time_frame>7 weeks</time_frame>
    <description>Incidence of COVID-19 related symptoms, that may include: Temperature over 37.8 degrees Celsius, Shortness of Breath, Cough.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>COVID 19</condition>
  <arm_group>
    <arm_group_label>Hydroxychloroquine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>400mg twice a day on day 1 followed by 400 mg weekly for 7 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 tablets (Placebo White tablets) twice daily on day 1 followed by 2 tablets weekly for 7 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydroxychloroquine</intervention_name>
    <description>The treatment group that will receive Hydroxychloroquine (HCQ) 400mg twice a day on day 1 followed by 400 mg weekly for 7 weeks</description>
    <arm_group_label>Hydroxychloroquine</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older, all healthcare workers in direct contact with COVID-19 patients&#xD;
             (ex: physicians, nurses, pharmacists, etc.), the ability to swallow Oral medications,&#xD;
             without any GI abnormalities that may affect absorption. Who agree to participate in&#xD;
             the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to HCQ.&#xD;
&#xD;
          -  Pregnancy or breastfeeding.&#xD;
&#xD;
          -  Known history of Retinal disease not related to Macular degeneration, or preexisting&#xD;
             eye retinopathy.&#xD;
&#xD;
          -  Having a prior history of blood disorders such as aplastic anemia, agranulocytosis,&#xD;
             leukopenia, or thrombocytopenia.&#xD;
&#xD;
          -  Having a prior history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.&#xD;
&#xD;
          -  Having dermatitis, psoriasis, or porphyria.&#xD;
&#xD;
          -  History of lung disease or Pneumonia not related to COVID-19.&#xD;
&#xD;
          -  Taking CYP450 enzyme-inducing medications within 4 weeks of the start of taking HCQ&#xD;
             (Ex: Phenytoin, Carbamazepine, Phenobarbital, Primidone or Oxcarbazepine.&#xD;
&#xD;
          -  Currently taking QT-prolonging medications, which may include Antiarrhythmics,&#xD;
             Quinolones, Macrolides, select Antipsychotics and Antidepressants.&#xD;
&#xD;
          -  Team members planning to have major abdominal, thoracic, spine or CNS surgery during&#xD;
             the protocol period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nasser Al Ansari, FRCPath</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hamad Medical Corporation (HMC)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nasser Al Ansari, FRCPath</last_name>
    <phone>33554409</phone>
    <email>nalansari2@hamad.qa</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rajvir Singh, Ph.D.</last_name>
    <phone>55897044</phone>
    <email>rsingh@hamad.qa</email>
  </overall_contact_backup>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>August 7, 2020</last_update_submitted>
  <last_update_submitted_qc>August 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hydroxychloroquine</keyword>
  <keyword>Coronavirus Disease 2019</keyword>
  <keyword>Post Exposure Prophylaxis</keyword>
  <keyword>Center for Disease Control and Prevention</keyword>
  <keyword>Coded Record Form</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydroxychloroquine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>There is a plan to make IPD and related data dictionaries available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>One year</ipd_time_frame>
    <ipd_access_criteria>2021 to 2025</ipd_access_criteria>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://www.worldometers.info/coronavirus/</doc_url>
      <doc_comment>https://www.worldometers.info/coronavirus/</doc_comment>
    </study_doc>
    <study_doc>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://www.who.int/docs/default-source/coronaviruse/who-china-joint-mission-on-covid-19-final-report.pdf</doc_url>
      <doc_comment>https://www.who.int/docs/default-source/coronaviruse/who-china-joint-mission-on-covid-19-final-report.pdf</doc_comment>
    </study_doc>
  </study_docs>
  <!-- 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/NCT04437693
org study id: MRC-02-20-442
nct id: NCT04437693
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
More cases of COVID-19 pandemic are being reported daily around the world. It is highly
      infectious and, over 7 million people have been infected and more than 400,000 people have
      died globally till this date. Countries around the world are struggling to avoid the spread
      of this pandemic.

      Center for Disease Control and Prevention (CDC) confirmed that there are no approved drugs
      for COVID-19 treatment. Researchers around the globe, however, are researching different
      medications for COVID-19 patients, including the drug Hydroxychloroquine (HCQ), which is
      mainly used for Rheumatoid Arthritis and Malaria. Not enough data was obtained yet to know
      how well all of these medications are functioning. Therefore, aim to perform a randomized
      placebo-controlled trial to assess the impact of these medications on COVID -19 healthcare
      workers exposed while treating COVID 19 patients in Qatar to avoid causality and
      comorbidities in healthcare workers.

      It is considered as a weak base. Many viruses enter the host cells via endocytosis, as a
      result of which they are initially taken up into an intracellular compartment that is
      "typically fairly acidic" whereas; Hydroxychloroquine would alter the acidity of this
      compartment, which can interfere with the ability of viruses to escape into the host cell and
      start replicating. Another hypothesis on the rationale of the Antiviral activity of HCQ, is
      that HCQ may also alter the ability of the virus to bind to the outside of a host cell in the
      first place.

      An interventional, double-blind, placebo-controlled randomized trial that will include
      participants who will be healthcare workers at risks of exposure to COVID-19 while managing
      patients with confirmed infection.

      Study will compare the safety, efficacy and effectiveness of Post Exposure Prophylaxis (PEP)
      use of HCQ in healthcare workers at risk of exposure to COVID-19 patients, in comparison to
      Placebo in Qatar.
More cases of COVID-19 pandemic are being reported daily around the world. It is highly
      infectious and, over 7 million people have been infected and more than 400,000 people have
      died globally till this date. Countries around the world are struggling to avoid the spread
      of this pandemic. The most common symptoms of coronavirus disease are fever, fatigue, and dry
      cough. Most people (approximately 80 percent) recover from the disease without special care.
      The disease can be serious, and even fatal. Older people, and people with other medical
      conditions (such as asthma, diabetes, or heart disease), maybe more vulnerable to becoming
      severely ill. As the COVID-19 pandemic continues to affect communities throughout the world,
      the search for effective drugs remains a priority. Scientists across the globe are working to
      produce a vaccine, but unlikely to be available before 2021. Meanwhile, a growing number of
      countries have taken a series of systematic measures to curb coronavirus spread, including
      national lockdowns, meeting bans, school closings, closures of restaurants, bars, sports
      clubs etc

      Researchers used to evaluate the invitro effectiveness of several potential COVID-19
      treatments, including chloroquine (CQ) and redmeveir (RDV). The findings were found
      encouraging as 90 percent of the virus was inhibited by a low concentration of CQ and the
      results for RDV were even better-with an even lower concentration of this drug, achieving a
      virus inhibition of 90 percent. However, unless clinically verified, it cannot confirm these
      drugs for the treatment of COVID-19 patients. It is not known how well these medications
      function in people who are infected with COVID-19 and is still being studied. The first
      patient reported to be infected with COVID -19 in the U.S. was treated with RDV. The
      treatment started on the 7th day of hospitalization and on the 11th day after his symptoms
      were first identified. He started showing signs of progress on the very next day, presumably
      due to treatment with RDV. Further data, however, is required to confirm the effect of this
      treatment.

      Researchers in France have also been studying the effectiveness of hydroxychloroquine (HCQ)
      in a single-arm regimen to treat people with COVID-19. HCQ (and, in some cases, also
      antibiotic azithromycin) has been used in this study to treat individuals with the COVID-19
      virus in one setting. Investigators measured the amount of virus in swabs taken from these
      individuals and from a group of individuals who did not receive HCQ. A larger decrease in the
      volume of the virus from the individuals receiving HCQ occurred on a span of six days.
      However, the groups were not randomized. Individuals who did not receive HCQ were at various
      medical facilities and not necessarily like the individuals in the HCQ group. The results are
      intriguing. But it's important to note that scientists have expressed concerns about this
      study. Indeed, after the publication of these findings, a statement has been released in the
      journal that it did not meet the "expected standard" of research (6).

      Moreover, these two drugs HCQ and RDV were designed primarily to fight other diseases and not
      COVID-19. Few data are available indicating that either could have some interest in the
      treatment of the disease, but its complete effect on COVID-19 patients is not known. One
      reason why researchers are interested in this drug is the HCQ's ability to modulate the
      inflammatory response. Inflammation is the natural reaction of the body to bacteria, viruses,
      or other substances that attack it. Our immune system usually attacks and actively kills
      infected cells or foreign bodies. But this response may often fail to function properly
      particularly in autoimmune disorders where the body is mistakenly attacking itself. HCQ has
      subtle effects on a wide variety of immune cells, and it may be that one of these effects
      helps stimulate the body's ability to fight off Covid-19. The inflammatory response in
      COVID-19 can be so strong that it causes serious damage to the lungs, that is why patients
      with severe infections need ventilators

      Another hypothesis on the rationale of the Antiviral activity of HCQ, is that HCQ may also
      alter the ability of the virus to bind to the outside of a host cell in the first place.

      The gold standard of a drug trial is a placebo-controlled, randomized, double-blind study.
      One group of participants should receive the investigational drug and another group should
      receive a placebo. The individuals in each arm of the study should be randomized; the
      demographics of both groups should be similar. Finally, the participants should not know if
      they are receiving the investigational drug or a placebo and the healthcare workers should
      not know what they are administering. Only under these conditions, It can conclusively
      determine the safety and efficacy of a potential treatment.

      Center for Disease Control and Prevention (CDC) confirmed that there are no approved drugs
      for COVID-19 treatment. Researchers around the globe, however, are researching different
      medications for COVID-19 patients, including the drug Hydroxychloroquine, which is mainly
      used for the treatment of Rheumatoid Arthritis and Malaria. Not enough data was obtained yet
      to know how well all of these medications are functioning. Therefore, aim to perform a
      randomized placebo-controlled trial to assess the impact of these medications on healthcare
      workers who exposed for the treatment of COVID -19 patients in Qatar.

      Rational to conduct a clinical trial on HCQ: It is considered as a weak base. Many viruses
      enter the host cells via endocytosis, as a result of which they are initially taken up into
      an intracellular compartment that is "typically fairly acidic" whereas; Hydroxychloroquine
      would alter the acidity of this compartment, which can interfere with the ability of viruses
      to escape into the host cell and start replicating. Another hypothesis on the rationale of
      the Antiviral activity of HCQ, is that HCQ may also alter the ability of the virus to bind to
      the outside of a host cell in the first place.

      Hypothesis:

      HCQ will be more safe and effective in comparison to placebo in the prevention of COVID 19
      cases, in healthcare workers exposed to COVID 19 patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: An interventional, double-blind, placebo-controlled randomized trial
primary purpose: Prevention
masking: Single (Participant)
masking description: The process of keeping the study group assignment hidden after allocation will be used where the investigator and participants will be unaware of the drug.A double blind randomized clinical trial has been proposed having 250 subjects in each arm. 500 subjects will be selected using randomly permuted blocks of 2,4, and 8 for the random process to allocate subjects into the two groups equally by using computer software.
measure: Prevention of SARS-CoV-2 infection
time frame: 7 Months
description: Prevention of SARS-CoV-2 infection as determined by negative RT-PCR of the participants in the treatment group through swabbing that will be conducted on a weekly basis (Swabbing will be conducted at baseline and weekly through the end of the treatment period
measure: Presence of any adverse effects related to HCQ
time frame: 7 months
description: To find out the adverse effects related to HCQ such as : skin rashes, especially those made worse by sunlight, feeling sick (nausea) or indigestion, diarrhea, headaches, bleaching of the hair or mild hair loss, tinnitus (ringing in the ears) visual problem
measure: Incidence of COVID-19 related symptoms
time frame: 7 weeks
description: Incidence of COVID-19 related symptoms, that may include: Temperature over 37.8 degrees Celsius, Shortness of Breath, Cough.
arm group label: Hydroxychloroquine
arm group type: Experimental
description: 400mg twice a day on day 1 followed by 400 mg weekly for 7 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: 2 tablets (Placebo White tablets) twice daily on day 1 followed by 2 tablets weekly for 7 weeks
intervention type: Drug
intervention name: Hydroxychloroquine
description: The treatment group that will receive Hydroxychloroquine (HCQ) 400mg twice a day on day 1 followed by 400 mg weekly for 7 weeks
arm group label: Hydroxychloroquine
arm group label: Placebo
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nasser Al Ansari, FRCPath
role: Principal Investigator
affiliation: Hamad Medical Corporation (HMC)
last name: Nasser Al Ansari, FRCPath
phone: 33554409
email: nalansari2@hamad.qa
last name: Rajvir Singh, Ph.D.
phone: 55897044
email: rsingh@hamad.qa
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Hydroxychloroquine
sharing ipd: Yes
ipd description: There is a plan to make IPD and related data dictionaries available.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: One year
ipd access criteria: 2021 to 2025
study doc: 
study doc: 