<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/NCT04421664</url>
  </required_header>
  <id_info>
    <org_study_id>2020-6549</org_study_id>
    <nct_id>NCT04421664</nct_id>
  </id_info>
  <brief_title>Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP Canada)</brief_title>
  <official_title>Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP Canada)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eastern Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study Objective:&#xD;
&#xD;
      To test if early preemptive hydroxychloroquine therapy can prevent disease progression in&#xD;
      persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom&#xD;
      severity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging viral&#xD;
      infection causing COVID19. Therapy is generally not given to persons who are not&#xD;
      hospitalized.&#xD;
&#xD;
      Hydroxychloroquine may have antiviral effects against SARS-CoV2 which may decrease disease&#xD;
      severity when given early. This trial will use a modification of standard malaria dosing of&#xD;
      hydroxychloroquine to provide preemptive therapy for those with early symptoms.&#xD;
&#xD;
      This study is a continuation of NCT04308668 which looked at post-exposure prophylaxis (now&#xD;
      closed) and early treatment in the USA (now closed, data to be pooled) and Canada (which&#xD;
      continues in this study). On April 28, 2020 NCT04308668 changed its primary outcome to&#xD;
      symptomatic improvement in the preemptive therapy arm. This study continues enrollment for&#xD;
      the primary ordinal outcome of hospitalization; hospitalization with intensive care stay; or&#xD;
      death.&#xD;
&#xD;
      People in the participating Canadian provinces can help answer this critically important&#xD;
      question. No in-person visits are needed.&#xD;
&#xD;
      The doses of hydroxychloroquine being used have been approved by Health Canada.&#xD;
&#xD;
      This trial is targeting the following groups of people:&#xD;
&#xD;
      If you are symptomatic with a positive COVID-19 test within the first 4 days of symptoms and&#xD;
      are not hospitalized; OR If you have had occupational exposure with known exposure to someone&#xD;
      with lab-confirmed COVID-19 within the last 14 days AND have compatible symptoms starting&#xD;
      within the last 4 days;&#xD;
&#xD;
      You may participate if you live anywhere in the Canadian Provinces of Quebec, Manitoba,&#xD;
      Alberta, British Columbia, Newfoundland or Ontario.&#xD;
&#xD;
      For information on how to participate in the research trial, go to:&#xD;
&#xD;
      www.covid-19research.ca&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Request of Health Canada after publication of https://doi.org/10.7326/M20-4207&#xD;
  </why_stopped>
  <start_date type="Actual">March 25, 2020</start_date>
  <completion_date type="Actual">August 17, 2020</completion_date>
  <primary_completion_date type="Actual">August 17, 2020</primary_completion_date>
  <phase>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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ordinal Scale of COVID19 Disease Severity at 14 days</measure>
    <time_frame>14 days</time_frame>
    <description>Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Hospitalization</measure>
    <time_frame>14 days</time_frame>
    <description>Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of COVID-19 related Death</measure>
    <time_frame>90 days</time_frame>
    <description>Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of all-cause Death</measure>
    <time_frame>90 days</time_frame>
    <description>Outcome reported as the number of participants in each arm who expire due to all causes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of All-Cause Study Medicine Discontinuation or Withdrawal</measure>
    <time_frame>14 days</time_frame>
    <description>Outcome reported as the number of participants in each arm who discontinue or withdraw medication use for any reason.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall symptom severity at 5 and 14 days</measure>
    <time_frame>5 and 14 days</time_frame>
    <description>Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall change in disease severity over 14 days among those who are symptomatic at baseline</measure>
    <time_frame>14 days</time_frame>
    <description>Repeated Measure mixed regression model of change in: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Corona Virus Infection</condition>
  <condition>SARS-CoV Infection</condition>
  <condition>Coronavirus</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will receive the study drug, hydroxychloroquine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants in this arm will receive a placebo treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydroxychloroquine</intervention_name>
    <description>200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral tablet</intervention_name>
    <description>4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Age 18 years of age or older AND provision of informed consent&#xD;
&#xD;
        WITH&#xD;
&#xD;
        Symptomatic COVID-19 disease with confirmed diagnosis with PCR+ SARS-CoV-2 within &lt;= 4 days&#xD;
        of symptoms&#xD;
&#xD;
        OR&#xD;
&#xD;
        Healthcare worker with compatible symptoms with exposure to known PCR+ case &lt;= 14 days (and&#xD;
        no available/pending testing for the individual).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current hospitalization&#xD;
&#xD;
          -  Allergy to chloroquine or hydroxychloroquine&#xD;
&#xD;
          -  Severe diarrhea and/or vomiting&#xD;
&#xD;
          -  Significant hepatic impairment defined as known cirrhosis with history of hepatic&#xD;
             encephalopathy or ascites.&#xD;
&#xD;
          -  Prior retinal eye disease&#xD;
&#xD;
          -  Concurrent malignancy requiring chemotherapy&#xD;
&#xD;
          -  Known Chronic Kidney disease, Stage 4 or 5 or dialysis.&#xD;
&#xD;
          -  Known glucose-6 phosphate dehydrogenase (G6PD) deficiency.&#xD;
&#xD;
          -  Known ventricular arrythmia, known prolonged QTc interval, or any known episode of&#xD;
             sudden cardiac death&#xD;
&#xD;
          -  Known Porphyria&#xD;
&#xD;
          -  Weight &lt;40 kg&#xD;
&#xD;
          -  Known Pregnancy of Breastfeeding&#xD;
&#xD;
          -  Current use of chloroquine or hydroxychloroquine&#xD;
&#xD;
          -  Current use of Artemether, Dapsone, Lumefantrine or Mefloquine&#xD;
&#xD;
          -  Current use of Cardiac medicines: amiodarone, digoxin, dofetilide, flecainide,&#xD;
             procainamide, sotalol, or propafenone&#xD;
&#xD;
          -  Current use of the following antimicrobials: levofloxacin, ciprofloxacin,&#xD;
             moxifloxacin, azithromycin, clarithromycin, erythromycin, ketoconazole, or&#xD;
             itraconazole&#xD;
&#xD;
          -  Current use of the following antidepressants: amitriptyline, citalopram, desipramine,&#xD;
             escitalopram, imipramine, doxepin, fluoxetine, sertraline, bupropion (Wellbutrin), or&#xD;
             venlafaxine&#xD;
&#xD;
          -  Current use of the following antipsychotic or mood stabilizers: haloperidol,&#xD;
             droperidol, lithium, quetiapine, thioridazine, ziprasidone&#xD;
&#xD;
          -  Current use of methadone&#xD;
&#xD;
          -  Current use of Sumatriptan, Zolmitriptan other than &quot;as needed&quot;&#xD;
&#xD;
          -  Current use of systemic chemotherapy&#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>Todd C Lee, MD MPH FIDSA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Institute of the McGill University Health Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of British Columbia</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Health</name>
      <address>
        <city>Saint John's</city>
        <state>Newfoundland and Labrador</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McMaster University</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lawson Health Research Institute</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute of the McGill University Health Centre</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4A3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Lother SA, Abassi M, Agostinis A, Bangdiwala AS, Cheng MP, Drobot G, Engen N, Hullsiek KH, Kelly LE, Lee TC, Lofgren SM, MacKenzie LJ, Marten N, McDonald EG, Okafor EC, Pastick KA, Pullen MF, Rajasingham R, Schwartz I, Skipper CP, Turgeon AF, Zarychanski R, Boulware DR. Post-exposure prophylaxis or pre-emptive therapy for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): study protocol for a pragmatic randomized-controlled trial. Can J Anaesth. 2020 Sep;67(9):1201-1211. doi: 10.1007/s12630-020-01684-7. Epub 2020 May 7.</citation>
    <PMID>32383125</PMID>
  </reference>
  <reference>
    <citation>Lofgren SM, Nicol MR, Bangdiwala AS, Pastick KA, Okafor EC, Skipper CP, Pullen MF, Engen NW, Abassi M, Williams DA, Nascene AA, Axelrod ML, Lother SA, MacKenzie LJ, Drobot G, Marten N, Cheng MP, Zarychanski R, Schwartz IS, Silverman M, Chagla Z, Kelly LE, McDonald EG, Lee TC, Hullsiek KH, Boulware DR, Rajasingham R. Safety of Hydroxychloroquine Among Outpatient Clinical Trial Participants for COVID-19. Open Forum Infect Dis. 2020 Oct 19;7(11):ofaa500. doi: 10.1093/ofid/ofaa500. eCollection 2020 Nov.</citation>
    <PMID>33204764</PMID>
  </reference>
  <results_reference>
    <citation>Skipper CP, Pastick KA, Engen NW, Bangdiwala AS, Abassi M, Lofgren SM, Williams DA, Okafor EC, Pullen MF, Nicol MR, Nascene AA, Hullsiek KH, Cheng MP, Luke D, Lother SA, MacKenzie LJ, Drobot G, Kelly LE, Schwartz IS, Zarychanski R, McDonald EG, Lee TC, Rajasingham R, Boulware DR. Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial. Ann Intern Med. 2020 Oct 20;173(8):623-631. doi: 10.7326/M20-4207. Epub 2020 Jul 16. Erratum In: Ann Intern Med. 2021 Mar;174(3):435.</citation>
    <PMID>32673060</PMID>
  </results_reference>
  <results_reference>
    <citation>Boulware DR, Pullen MF, Bangdiwala AS, Pastick KA, Lofgren SM, Okafor EC, Skipper CP, Nascene AA, Nicol MR, Abassi M, Engen NW, Cheng MP, LaBar D, Lother SA, MacKenzie LJ, Drobot G, Marten N, Zarychanski R, Kelly LE, Schwartz IS, McDonald EG, Rajasingham R, Lee TC, Hullsiek KH. A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19. N Engl J Med. 2020 Aug 6;383(6):517-525. doi: 10.1056/NEJMoa2016638. Epub 2020 Jun 3.</citation>
    <PMID>32492293</PMID>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>April 5, 2022</last_update_submitted>
  <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
    <investigator_full_name>Todd C. Lee MD MPH FIDSA</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>SARS-COV-2</keyword>
  <keyword>Coronavirus</keyword>
  <keyword>Corona virus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Severe Acute Respiratory Syndrome</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>De-identified dataset will be included with publication.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>At time of publication</ipd_time_frame>
    <ipd_access_criteria>To be publicly provided</ipd_access_criteria>
  </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/NCT04421664
org study id: 2020-6549
nct id: NCT04421664
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Study Objective:

      To test if early preemptive hydroxychloroquine therapy can prevent disease progression in
      persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom
      severity.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging viral
      infection causing COVID19. Therapy is generally not given to persons who are not
      hospitalized.

      Hydroxychloroquine may have antiviral effects against SARS-CoV2 which may decrease disease
      severity when given early. This trial will use a modification of standard malaria dosing of
      hydroxychloroquine to provide preemptive therapy for those with early symptoms.

      This study is a continuation of NCT04308668 which looked at post-exposure prophylaxis (now
      closed) and early treatment in the USA (now closed, data to be pooled) and Canada (which
      continues in this study). On April 28, 2020 NCT04308668 changed its primary outcome to
      symptomatic improvement in the preemptive therapy arm. This study continues enrollment for
      the primary ordinal outcome of hospitalization; hospitalization with intensive care stay; or
      death.

      People in the participating Canadian provinces can help answer this critically important
      question. No in-person visits are needed.

      The doses of hydroxychloroquine being used have been approved by Health Canada.

      This trial is targeting the following groups of people:

      If you are symptomatic with a positive COVID-19 test within the first 4 days of symptoms and
      are not hospitalized; OR If you have had occupational exposure with known exposure to someone
      with lab-confirmed COVID-19 within the last 14 days AND have compatible symptoms starting
      within the last 4 days;

      You may participate if you live anywhere in the Canadian Provinces of Quebec, Manitoba,
      Alberta, British Columbia, Newfoundland or Ontario.

      For information on how to participate in the research trial, go to:

      www.covid-19research.ca
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Ordinal Scale of COVID19 Disease Severity at 14 days
time frame: 14 days
description: Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm.
measure: Incidence of Hospitalization
time frame: 14 days
description: Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.
measure: Incidence of COVID-19 related Death
time frame: 90 days
description: Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease.
measure: Incidence of all-cause Death
time frame: 90 days
description: Outcome reported as the number of participants in each arm who expire due to all causes.
measure: Incidence of All-Cause Study Medicine Discontinuation or Withdrawal
time frame: 14 days
description: Outcome reported as the number of participants in each arm who discontinue or withdraw medication use for any reason.
measure: Overall symptom severity at 5 and 14 days
time frame: 5 and 14 days
description: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)
measure: Overall change in disease severity over 14 days among those who are symptomatic at baseline
time frame: 14 days
description: Repeated Measure mixed regression model of change in: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)
arm group label: Treatment
arm group type: Experimental
description: Participants in this arm will receive the study drug, hydroxychloroquine.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants in this arm will receive a placebo treatment.
intervention type: Drug
intervention name: Hydroxychloroquine
description: 200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days
arm group label: Treatment
intervention type: Drug
intervention name: Placebo oral tablet
description: 4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Todd C Lee, MD MPH FIDSA
role: Principal Investigator
affiliation: Research Institute of the McGill University Health Centre
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
citation: Lother SA, Abassi M, Agostinis A, Bangdiwala AS, Cheng MP, Drobot G, Engen N, Hullsiek KH, Kelly LE, Lee TC, Lofgren SM, MacKenzie LJ, Marten N, McDonald EG, Okafor EC, Pastick KA, Pullen MF, Rajasingham R, Schwartz I, Skipper CP, Turgeon AF, Zarychanski R, Boulware DR. Post-exposure prophylaxis or pre-emptive therapy for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): study protocol for a pragmatic randomized-controlled trial. Can J Anaesth. 2020 Sep;67(9):1201-1211. doi: 10.1007/s12630-020-01684-7. Epub 2020 May 7.
PMID: 32383125
citation: Lofgren SM, Nicol MR, Bangdiwala AS, Pastick KA, Okafor EC, Skipper CP, Pullen MF, Engen NW, Abassi M, Williams DA, Nascene AA, Axelrod ML, Lother SA, MacKenzie LJ, Drobot G, Marten N, Cheng MP, Zarychanski R, Schwartz IS, Silverman M, Chagla Z, Kelly LE, McDonald EG, Lee TC, Hullsiek KH, Boulware DR, Rajasingham R. Safety of Hydroxychloroquine Among Outpatient Clinical Trial Participants for COVID-19. Open Forum Infect Dis. 2020 Oct 19;7(11):ofaa500. doi: 10.1093/ofid/ofaa500. eCollection 2020 Nov.
PMID: 33204764
citation: Skipper CP, Pastick KA, Engen NW, Bangdiwala AS, Abassi M, Lofgren SM, Williams DA, Okafor EC, Pullen MF, Nicol MR, Nascene AA, Hullsiek KH, Cheng MP, Luke D, Lother SA, MacKenzie LJ, Drobot G, Kelly LE, Schwartz IS, Zarychanski R, McDonald EG, Lee TC, Rajasingham R, Boulware DR. Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial. Ann Intern Med. 2020 Oct 20;173(8):623-631. doi: 10.7326/M20-4207. Epub 2020 Jul 16. Erratum In: Ann Intern Med. 2021 Mar;174(3):435.
PMID: 32673060
citation: Boulware DR, Pullen MF, Bangdiwala AS, Pastick KA, Lofgren SM, Okafor EC, Skipper CP, Nascene AA, Nicol MR, Abassi M, Engen NW, Cheng MP, LaBar D, Lother SA, MacKenzie LJ, Drobot G, Marten N, Zarychanski R, Kelly LE, Schwartz IS, McDonald EG, Rajasingham R, Lee TC, Hullsiek KH. A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19. N Engl J Med. 2020 Aug 6;383(6):517-525. doi: 10.1056/NEJMoa2016638. Epub 2020 Jun 3.
PMID: 32492293
responsible party type: Principal Investigator
investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
investigator full name: Todd C. Lee MD MPH FIDSA
investigator title: Associate Professor of Medicine
mesh term: Infections
mesh term: Communicable Diseases
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Severe Acute Respiratory Syndrome
mesh term: Hydroxychloroquine
sharing ipd: Yes
ipd description: De-identified dataset will be included with publication.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: At time of publication
ipd access criteria: To be publicly provided