<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/NCT04404218</url>
  </required_header>
  <id_info>
    <org_study_id>CTO3176</org_study_id>
    <nct_id>NCT04404218</nct_id>
  </id_info>
  <brief_title>The Açaí Berry COVID-19 Anti-Inflammation Trial</brief_title>
  <acronym>ACAI</acronym>
  <official_title>Randomized Clinical Trial of Açaí Palm Berry Extract as an Intervention in Patients Diagnosed With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Health Network, Toronto</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>
      The Açaí trial will be testing if the açaí berry extract, a safe natural product with&#xD;
      anti-inflammatory properties, can be used as a treatment option in adult patients with&#xD;
      COVID-19 in the community.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current COVID-19 pandemic is caused by the novel coronavirus (SARS-Cov-2). The virus&#xD;
      origins have been studied and evidence so far suggests it originates in bats, with spread to&#xD;
      humans likely mediated by an intermediate mammalian. Bats have a dampened Nod-like receptor&#xD;
      family, pyrin-containing 3 (NLRP3)-mediated inflammation. Dampening NLRP3-mediated&#xD;
      inflammation has been associated with the asymptotic viral status, therefore it is plausible&#xD;
      that the pathogenic inflammatory response of SARS-CoV-2 might be associated with activation&#xD;
      of NLRP3 inflammasome. Data show that the natural extract of Açaí Palm Berry (Euterpe&#xD;
      oleracea Mart.) is a potent inhibitor of NLRP3. This is a safe, inexpensive, and readily&#xD;
      available natural health supplement which could be a rapid response treatment intervention&#xD;
      for patients with COVID-19.&#xD;
&#xD;
      Our primary objective is to establish whether açai palm berry extract (Euterpe oleracea),&#xD;
      given to community-dwelling adult patients diagnosed with COVID-19, compared to placebo,&#xD;
      improves outcomes over 30 days on the 7-point ordinal scale described by Cao et al, and which&#xD;
      is being used widely in COVID-19 trials with the aim of harmonizing endpoints. This study&#xD;
      will be a prospective, double-blinded, placebo-controlled, randomized, multicentre clinical&#xD;
      trial of Açaí Palm Berry extract in adult patients tested positive for SARS-Cov-2 in the last&#xD;
      7 days and that are currently being treated in the outpatient setting. The intervention group&#xD;
      will receive 3 capsules of 520mg (one capsule every eight hours) of Acai Palm Berry extract&#xD;
      (Nature's Way, NPN80038874) for 30 days. The non-intervention group will receive placebo&#xD;
      pills, on top of standard clinical care. Our main endpoint will be the 7-point ordinal scale.&#xD;
&#xD;
      This project has the benefit of offering a safe and widely used natural extract as a&#xD;
      potential treatment strategy to decrease inflammation and improve disease outcomes in&#xD;
      patients with COVID-19. With no vaccine currently available, the search for effective&#xD;
      treatments is a timely approach. The potential impact of such a therapeutic agent, if&#xD;
      effective, can be quite vast given that it can be readily used by anyone and, most&#xD;
      importantly, is affordable in many countries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 4, 2020</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">June 15, 2022</primary_completion_date>
  <phase>Phase 2</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>Prospective, double-blinded, placebo-controlled, randomized, multicentre clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double blinding, using placebo pills.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>7-point ordinal symptom scale</measure>
    <time_frame>30 days</time_frame>
    <description>Symptom comparison between patients from the treatment vs control group, using an ordinal symptom scale based on the WHO scale. Patients who were hospitalized will be classified according to their worst score over 30 days and non-hospitalized patients according to their score at 30 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The composite of all-cause mortality and need for mechanical ventilation</measure>
    <time_frame>30 days</time_frame>
    <description>First occurrence of all-cause mortality or need for mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The composite of all-cause mortality and hospitalization</measure>
    <time_frame>30 days</time_frame>
    <description>First occurrence of all-cause mortality or hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>30 days</time_frame>
    <description>All-cause mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for mechanical ventilation</measure>
    <time_frame>30 days</time_frame>
    <description>Need for mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for hospitalization</measure>
    <time_frame>30 days</time_frame>
    <description>Need for hospitalization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">480</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Açaí palm berry extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Açaí palm berry extract is a powerful antioxidant with no known side-effects and is widely consumed in Brazil. Açaí palm berry chemical composition has been established and includes several antioxidants - gallic acid, catechin, chlorogenic acid, caffeic acid, p-coumaric acid, epicatechin, orientin, cyanidin-3-0-glucoside, luteolin and apigenin. Orientin is the most concentrated compound (7,96mg/g) and this compound is able to modulate the NLRP3 inflammasome.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This study will be double-blinded and placebo-controlled. To ensure double-blinding, placebo and active compound capsules will be over-encapsulated with DBCAPS® capsules, which were developed with a tamper-evident design to address the clinical trial challenges of testing without bias. These capsules are made of gelatin and have no interaction with bioavailability.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Açaí palm berry extract - natural product</intervention_name>
    <description>Patients will be prescribed to take 1 capsule (520mg) of Açaí Palm Berry every 8 hours for a total of 3 capsules a day, during 30 days. Total dose: 1,560mg/day of Açaí Berry extract.</description>
    <arm_group_label>Açaí palm berry extract</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Patients will take 1 placebo pill every 8 hours (total of 3 capsules a day) for 30 days.</description>
    <arm_group_label>Placebo arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults over 40 years of age; and&#xD;
&#xD;
          -  Mild to moderate symptoms including fever, dry cough, and tiredness; and&#xD;
&#xD;
          -  Tested positive for SARS-Cov-2, via virological diagnosis (PCR), in the last 7 days;&#xD;
             and&#xD;
&#xD;
          -  Not hospitalized at the time of randomization, with no limitations on activities; and&#xD;
&#xD;
          -  Willingness to complete questionnaires and records associated with the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hospitalized patients at the time of enrollment; or&#xD;
&#xD;
          -  Known allergy to study medication or its non-medicinal ingredients; or&#xD;
&#xD;
          -  Currently taking açai extract or juice; or&#xD;
&#xD;
          -  Chronic severe renal impairment (creatinine clearance &lt;30 mL/min or on renal&#xD;
             replacement therapy); or&#xD;
&#xD;
          -  Pregnant or breastfeeding patients; or&#xD;
&#xD;
          -  Women who are planning to become pregnant during the study; or&#xD;
&#xD;
          -  End-stage cancer or patients in whom imminent demise is anticipated and there is no&#xD;
             commitment to active ongoing intervention; or&#xD;
&#xD;
          -  Unable to provide informed consent; or&#xD;
&#xD;
          -  Patients taking antiplatelet/blood-thinning medication; or&#xD;
&#xD;
          -  Patients with unstable metabolic disease/chronic diseases/ diseases with any&#xD;
             comorbidities and/or any serious medical condition or abnormality of clinical&#xD;
             laboratory tests that precludes the patient's safe participation in and completion of&#xD;
             the study or puts them in a greater risk of developing severe symptoms (e.g.&#xD;
             Individuals with an acute infectious disease, immune-compromised, self-reported&#xD;
             confirmation of HIV, other lung diseases such as asthma, emphysema, neurological&#xD;
             conditions); or&#xD;
&#xD;
          -  Patients who participated in other clinical research studies 30 days prior to&#xD;
             screening; or&#xD;
&#xD;
          -  Patients who are participating in another clinical trial at the same time.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Farkouh, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peter Munk Cardiac Centre; University Health Network; University of Toronto</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ana Andreazza, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Pharmacology &amp; Toxicology; University of Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto de Pesquisas em Saude (IPS)/ Universidade de Caxias do Sul (UCS)</name>
      <address>
        <city>Caxias Do Sul</city>
        <state>RS</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Prevent Senior (IPS) - Hospital Sancta Maggiore</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Health Institute Research Inc</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M1B 4Z8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Machado AK, Andreazza AC, da Silva TM, Boligon AA, do Nascimento V, Scola G, Duong A, Cadona FC, Ribeiro EE, da Cruz IB. Neuroprotective Effects of Acai (Euterpe oleracea Mart.) against Rotenone In Vitro Exposure. Oxid Med Cell Longev. 2016;2016:8940850. doi: 10.1155/2016/8940850. Epub 2016 Oct 3.</citation>
    <PMID>27781077</PMID>
  </reference>
  <reference>
    <citation>Machado AK, Cadoná FC, Assmann CE, Andreazza AC, Duarte MMMF, Branco CS, Zhou X, Souza DV, Ribeiro EE, Cruz IBM. Açaí (Euterpe oleracea Mart.) has anti-inflammatory potential through NLRP3-inflammasome modulation. Journal of Functional Foods. Volume 56, 2019, Pages 364-371, https://doi.org/10.1016/j.jff.2019.03.034.</citation>
  </reference>
  <reference>
    <citation>Kim HK, Chen W, Andreazza AC. The Potential Role of the NLRP3 Inflammasome as a Link between Mitochondrial Complex I Dysfunction and Inflammation in Bipolar Disorder. Neural Plast. 2015;2015:408136. doi: 10.1155/2015/408136. Epub 2015 May 13.</citation>
    <PMID>26075098</PMID>
  </reference>
  <reference>
    <citation>Kim HK, Andreazza AC, Elmi N, Chen W, Young LT. Nod-like receptor pyrin containing 3 (NLRP3) in the post-mortem frontal cortex from patients with bipolar disorder: A potential mediator between mitochondria and immune-activation. J Psychiatr Res. 2016 Jan;72:43-50. doi: 10.1016/j.jpsychires.2015.10.015. Epub 2015 Oct 26.</citation>
    <PMID>26540403</PMID>
  </reference>
  <reference>
    <citation>Ulbricht C, Brigham A, Burke D, Costa D, Giese N, Iovin R, Grimes Serrano JM, Tanguay-Colucci S, Weissner W, Windsor R. An evidence-based systematic review of acai (Euterpe oleracea) by the Natural Standard Research Collaboration. J Diet Suppl. 2012 Jun;9(2):128-47. doi: 10.3109/19390211.2012.686347.</citation>
    <PMID>22607647</PMID>
  </reference>
  <reference>
    <citation>Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, Ruan L, Song B, Cai Y, Wei M, Li X, Xia J, Chen N, Xiang J, Yu T, Bai T, Xie X, Zhang L, Li C, Yuan Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med. 2020 May 7;382(19):1787-1799. doi: 10.1056/NEJMoa2001282. Epub 2020 Mar 18.</citation>
    <PMID>32187464</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 27, 2022</last_update_submitted>
  <last_update_submitted_qc>May 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Health Network, Toronto</investigator_affiliation>
    <investigator_full_name>Michael Farkouh</investigator_full_name>
    <investigator_title>Chair &amp; Director, Peter Munk Centre of Excellence in Multinational Clinical Trials</investigator_title>
  </responsible_party>
  <keyword>açaí berry</keyword>
  <keyword>COVID</keyword>
  <keyword>community care patients</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04404218
org study id: CTO3176
nct id: NCT04404218
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Açaí trial will be testing if the açaí berry extract, a safe natural product with
      anti-inflammatory properties, can be used as a treatment option in adult patients with
      COVID-19 in the community.
The current COVID-19 pandemic is caused by the novel coronavirus (SARS-Cov-2). The virus
      origins have been studied and evidence so far suggests it originates in bats, with spread to
      humans likely mediated by an intermediate mammalian. Bats have a dampened Nod-like receptor
      family, pyrin-containing 3 (NLRP3)-mediated inflammation. Dampening NLRP3-mediated
      inflammation has been associated with the asymptotic viral status, therefore it is plausible
      that the pathogenic inflammatory response of SARS-CoV-2 might be associated with activation
      of NLRP3 inflammasome. Data show that the natural extract of Açaí Palm Berry (Euterpe
      oleracea Mart.) is a potent inhibitor of NLRP3. This is a safe, inexpensive, and readily
      available natural health supplement which could be a rapid response treatment intervention
      for patients with COVID-19.

      Our primary objective is to establish whether açai palm berry extract (Euterpe oleracea),
      given to community-dwelling adult patients diagnosed with COVID-19, compared to placebo,
      improves outcomes over 30 days on the 7-point ordinal scale described by Cao et al, and which
      is being used widely in COVID-19 trials with the aim of harmonizing endpoints. This study
      will be a prospective, double-blinded, placebo-controlled, randomized, multicentre clinical
      trial of Açaí Palm Berry extract in adult patients tested positive for SARS-Cov-2 in the last
      7 days and that are currently being treated in the outpatient setting. The intervention group
      will receive 3 capsules of 520mg (one capsule every eight hours) of Acai Palm Berry extract
      (Nature's Way, NPN80038874) for 30 days. The non-intervention group will receive placebo
      pills, on top of standard clinical care. Our main endpoint will be the 7-point ordinal scale.

      This project has the benefit of offering a safe and widely used natural extract as a
      potential treatment strategy to decrease inflammation and improve disease outcomes in
      patients with COVID-19. With no vaccine currently available, the search for effective
      treatments is a timely approach. The potential impact of such a therapeutic agent, if
      effective, can be quite vast given that it can be readily used by anyone and, most
      importantly, is affordable in many countries.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, double-blinded, placebo-controlled, randomized, multicentre clinical trial
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double blinding, using placebo pills.
measure: 7-point ordinal symptom scale
time frame: 30 days
description: Symptom comparison between patients from the treatment vs control group, using an ordinal symptom scale based on the WHO scale. Patients who were hospitalized will be classified according to their worst score over 30 days and non-hospitalized patients according to their score at 30 days.
measure: The composite of all-cause mortality and need for mechanical ventilation
time frame: 30 days
description: First occurrence of all-cause mortality or need for mechanical ventilation
measure: The composite of all-cause mortality and hospitalization
time frame: 30 days
description: First occurrence of all-cause mortality or hospitalization
measure: All-cause mortality
time frame: 30 days
description: All-cause mortality
measure: Need for mechanical ventilation
time frame: 30 days
description: Need for mechanical ventilation
measure: Need for hospitalization
time frame: 30 days
description: Need for hospitalization
arm group label: Açaí palm berry extract
arm group type: Experimental
description: Açaí palm berry extract is a powerful antioxidant with no known side-effects and is widely consumed in Brazil. Açaí palm berry chemical composition has been established and includes several antioxidants - gallic acid, catechin, chlorogenic acid, caffeic acid, p-coumaric acid, epicatechin, orientin, cyanidin-3-0-glucoside, luteolin and apigenin. Orientin is the most concentrated compound (7,96mg/g) and this compound is able to modulate the NLRP3 inflammasome.
arm group label: Placebo arm
arm group type: Placebo Comparator
description: This study will be double-blinded and placebo-controlled. To ensure double-blinding, placebo and active compound capsules will be over-encapsulated with DBCAPS® capsules, which were developed with a tamper-evident design to address the clinical trial challenges of testing without bias. These capsules are made of gelatin and have no interaction with bioavailability.
intervention type: Dietary Supplement
intervention name: Açaí palm berry extract - natural product
description: Patients will be prescribed to take 1 capsule (520mg) of Açaí Palm Berry every 8 hours for a total of 3 capsules a day, during 30 days. Total dose: 1,560mg/day of Açaí Berry extract.
arm group label: Açaí palm berry extract
intervention type: Other
intervention name: Placebo
description: Patients will take 1 placebo pill every 8 hours (total of 3 capsules a day) for 30 days.
arm group label: Placebo arm
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Farkouh, MD, MSc
role: Principal Investigator
affiliation: Peter Munk Cardiac Centre; University Health Network; University of Toronto
last name: Ana Andreazza, PhD
role: Principal Investigator
affiliation: Department of Pharmacology & Toxicology; University of Toronto
facility: 
facility: 
facility: 
country: Brazil
country: Canada
citation: Machado AK, Andreazza AC, da Silva TM, Boligon AA, do Nascimento V, Scola G, Duong A, Cadona FC, Ribeiro EE, da Cruz IB. Neuroprotective Effects of Acai (Euterpe oleracea Mart.) against Rotenone In Vitro Exposure. Oxid Med Cell Longev. 2016;2016:8940850. doi: 10.1155/2016/8940850. Epub 2016 Oct 3.
PMID: 27781077
citation: Machado AK, Cadoná FC, Assmann CE, Andreazza AC, Duarte MMMF, Branco CS, Zhou X, Souza DV, Ribeiro EE, Cruz IBM. Açaí (Euterpe oleracea Mart.) has anti-inflammatory potential through NLRP3-inflammasome modulation. Journal of Functional Foods. Volume 56, 2019, Pages 364-371, https://doi.org/10.1016/j.jff.2019.03.034.
citation: Kim HK, Chen W, Andreazza AC. The Potential Role of the NLRP3 Inflammasome as a Link between Mitochondrial Complex I Dysfunction and Inflammation in Bipolar Disorder. Neural Plast. 2015;2015:408136. doi: 10.1155/2015/408136. Epub 2015 May 13.
PMID: 26075098
citation: Kim HK, Andreazza AC, Elmi N, Chen W, Young LT. Nod-like receptor pyrin containing 3 (NLRP3) in the post-mortem frontal cortex from patients with bipolar disorder: A potential mediator between mitochondria and immune-activation. J Psychiatr Res. 2016 Jan;72:43-50. doi: 10.1016/j.jpsychires.2015.10.015. Epub 2015 Oct 26.
PMID: 26540403
citation: Ulbricht C, Brigham A, Burke D, Costa D, Giese N, Iovin R, Grimes Serrano JM, Tanguay-Colucci S, Weissner W, Windsor R. An evidence-based systematic review of acai (Euterpe oleracea) by the Natural Standard Research Collaboration. J Diet Suppl. 2012 Jun;9(2):128-47. doi: 10.3109/19390211.2012.686347.
PMID: 22607647
citation: Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, Ruan L, Song B, Cai Y, Wei M, Li X, Xia J, Chen N, Xiang J, Yu T, Bai T, Xie X, Zhang L, Li C, Yuan Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med. 2020 May 7;382(19):1787-1799. doi: 10.1056/NEJMoa2001282. Epub 2020 Mar 18.
PMID: 32187464
responsible party type: Principal Investigator
investigator affiliation: University Health Network, Toronto
investigator full name: Michael Farkouh
investigator title: Chair & Director, Peter Munk Centre of Excellence in Multinational Clinical Trials
sharing ipd: No