<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/NCT04458519</url>
  </required_header>
  <id_info>
    <org_study_id>PROBCO</org_study_id>
    <secondary_id>249512</secondary_id>
    <nct_id>NCT04458519</nct_id>
  </id_info>
  <brief_title>Efficacy of Intranasal Probiotic Treatment to Reduce Severity of Symptoms in COVID19 Infection</brief_title>
  <official_title>Randomised Single Blinded Clinical Study of Efficacy of Intranasal Probiotic Treatment to Reduce Severity of Symptoms in COVID19 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre hospitalier de l'Université de Montréal (CHUM)</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>
      Randomised, single-blinded trial. Patients with a diagnosis of COVID-19 infection within the&#xD;
      past 96 hours and not requiring hospitalization will be recruited into a trial of BID Nasal&#xD;
      irrigation for 14 days, followed by a 14 day observation period. Irrigation will be performed&#xD;
      with either Probiorinse probiotic nasal irrigation solution or NeilMed Sinus rinse. Patients&#xD;
      will be able to identify their treatments, but study staff will be blinded as to assignment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND/OBJECTIVE&#xD;
&#xD;
      The potential role of the microbiome in COVID-19 disease remains little explored, yert may&#xD;
      offer an unique therapeutic opportunity for its treatment. Airway inflammation and microbiome&#xD;
      dysbiosis is present in COVID-19 patients and is related to evolution. The limited&#xD;
      information on airway inflammation in COVID-19 suggests greater inflammation, as assessed by&#xD;
      serum markers of inflammation, is associated by more severe disease. Late cell-mediated&#xD;
      T-cell activation is paradoxically accompanied by TLR expression downregulation, which&#xD;
      contributes to dysfunctional immune regulation. Individual predisposition to heightened&#xD;
      inflammatory responses may contribute to this.&#xD;
&#xD;
      The investigators believe this early TLR downregulation is an important feature of the&#xD;
      disease, allowing the disease to reproduce unchecked and spread during a prolonged&#xD;
      asymptomatic shedding period.&#xD;
&#xD;
      Immune-evasion strategies are common to several viral infections such as influenza,&#xD;
      respiratory syncytial virus, and human rhinovirus, COVID-19 may exploit this as well.&#xD;
&#xD;
      Lung microbiome data in COVID-19 is limited, but a small dataset of 8 hospitalised cases has&#xD;
      been reported from China suggests pulmonary inflammation can be influenced by the microbiome&#xD;
      at the time of intubation, arguing the need for a more favorable upper airway microbiome.&#xD;
&#xD;
      Based on the above information, the investigators believe that administration of probiotic&#xD;
      bacteria directly to the upper airway via irrigation to patients receiving a diagnosis of&#xD;
      COVID-19 will improve the status of the upper airway microbiome and reduce symptom severity&#xD;
      and disease in patients with COVID-19 disease not requiring ICU admission or intubation.&#xD;
&#xD;
      The investigators believe intranasally applied 'health-inducing' bacteria will favorably&#xD;
      modulate the response to COVID-19 infection, reducing its severity and complications.&#xD;
      Probiorinse may exert potentially beneficial effects in COVID-19 infection via two potential&#xD;
      and distinct mechanisms:&#xD;
&#xD;
        1. Activation of the innate immune system via enhanced TLR signalling:&#xD;
&#xD;
           - Abundant TLR ligands present on the probiotic bacterial capsule may counter the&#xD;
           downregulation in TLR expression and function seen with COVID-19 infection.&#xD;
&#xD;
        2. Promotion of a 'healthy' microbiome profile in the nasopharynx:&#xD;
&#xD;
             -  Reducing &quot;seeding&quot; the lower respiratory tract with inappropriate bacteria or&#xD;
                pathogens.&#xD;
&#xD;
             -  Conditioning inappropriate or excessive immune responses of the airway&#xD;
&#xD;
      The purpose of this clinical trial is thus to compare the safety and validity of intranasal&#xD;
      irrigation with Lactococcus lactis W136 with saline nasal irrigation alone in patients with&#xD;
      mild COVID-19 infection.&#xD;
&#xD;
      METHODOLOGY&#xD;
&#xD;
      Consent process in the current context of the COVID-19 pandemic: Verbal consent and&#xD;
      confirmation of consent in writing or electronically.&#xD;
&#xD;
      Participants will be recruited via posted signs in the COVID-19 clinic and hospital Intranet&#xD;
      advertising a research project for individuals diagnosed with COVID-19 infection.&#xD;
&#xD;
      This study will include three (3) periods, which will take the form of telephone calls /&#xD;
      email contacts:&#xD;
&#xD;
        1. Eligibility determination period (Day 0)&#xD;
&#xD;
        2. Treatment period (Day 1 to Day 14): Probiorinse or Saline solution&#xD;
&#xD;
        3. Follow-up period (Day 21 and Day 28)&#xD;
&#xD;
      STATISTICAL ANALYSIS&#xD;
&#xD;
      Analysis population:&#xD;
&#xD;
      The primary analysis population for the efficacy endpoints will be the randomized ITT&#xD;
      population which includes all patients who have been allocated to a randomized treatment&#xD;
      regardless of whether the treatment kit was used or not. The efficacy analyses will be&#xD;
      conducted according to the treatment to which they were randomized.&#xD;
&#xD;
      The analysis population for safety endpoints is defined as all patients exposed to study&#xD;
      medication, regardless of the amount of treatment administered. The safety analyses will be&#xD;
      conducted according to the treatment patients actually received. The treatment emergent&#xD;
      period is defined as the time from the first administration of study medication to Day 14 of&#xD;
      post treatment period.&#xD;
&#xD;
      Data Analysis:&#xD;
&#xD;
      The following null hypothesis and alternative will be tested for the Probiorinse arm against&#xD;
      NeilMed Sinus Rinse:&#xD;
&#xD;
        -  H0: No treatment difference between Probiorinse and NeilMed Sinus Rinse.&#xD;
&#xD;
        -  H1: There is a treatment difference between Probiorinse and NeilMed Sinus Rinse&#xD;
&#xD;
      Descriptive statistics including number of subjects mean, standard error, and least squares&#xD;
      (LS) means will be provided. In addition, difference in LS means and the corresponding 95%&#xD;
      confidence intervals (CI) will be provided along with the p-values.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 16, 2020</start_date>
  <completion_date type="Actual">May 27, 2021</completion_date>
  <primary_completion_date type="Actual">May 27, 2021</primary_completion_date>
  <phase>N/A</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>Single-blinded, randomized, prospective trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
    <masking_description>Investigator responsible for product allocation and blinding is not in contact with study participant and will only be made aware of the process of their evolution in case of emergency.&#xD;
Study personel in daily contact with the patient are unaware of the patient treatment assignement and are thus blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in severity of COVID-19 infection</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change in severity of COVID-19 infection as assessed by number of days with any symptoms of COVID-19 infection greater than or equal to 35 as measured on VAS scale as assessed at the 28 day endpoint.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of days with any symptom of anosmia</measure>
    <time_frame>4 weeks</time_frame>
    <description>Number of days with any symptom of anosmia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal intensity attained in overall assessment of symptoms of COVID-19 infection as measured on Visual Analogue Scale (VAS).</measure>
    <time_frame>4 weeks</time_frame>
    <description>Maximal intensity attained in overall assessment of symptoms of COVID-19 infection as measured on Visual Analogue Scale (VAS). VAS scale from 0 to 100, with a higher score indicating a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days where rescue medication is required</measure>
    <time_frame>4 weeks</time_frame>
    <description>Number of days where rescue medication is required</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>COVID-19 Infection</condition>
  <arm_group>
    <arm_group_label>Probiorinse</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nasal irrigations with Probiorinse (2.4 Billion CFU (Colony-Forming Units) of Lactococcus Lactis W136, (NPN: 80085895)) twice-daily for a period of fourteen days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline solution</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nasal irrigations with saline (NeilMed Sinus Rinse, (NPN: 80027142)) twice-daily for a period of fourteen days</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Probiorinse</intervention_name>
    <description>Nasal irrigations with probiotic twice-daily for a period of fourteen days</description>
    <arm_group_label>Probiorinse</arm_group_label>
    <other_name>Natural health products</other_name>
    <other_name>Probiotic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saline solution</intervention_name>
    <description>Nasal irrigations with saline-only twice-daily for a period of fourteen days</description>
    <arm_group_label>Saline solution</arm_group_label>
    <other_name>Natural health product</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females aged 18-59 years&#xD;
&#xD;
          -  Positive diagnosis of COVID-19 infection less than 96 hours&#xD;
&#xD;
          -  Characteristic respiratory symptoms present but no more than mild to moderate&#xD;
&#xD;
          -  No need for oxygen&#xD;
&#xD;
          -  Temperature less than 38.0 ºC&#xD;
&#xD;
          -  Not presently being considered for hospitalisation or ICU admission&#xD;
&#xD;
          -  Able to perform nasal irrigation&#xD;
&#xD;
          -  Able to provide consent&#xD;
&#xD;
          -  Able to communicate with the study team by phone, text or email&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with pre-existing conditions or demographic features placing them at&#xD;
             increased risk of complications from COVID10 infection will not be included in this&#xD;
             study. These will be considered exclusion factors, thus individuals will be questioned&#xD;
             as to the presence or these factors during their telephone screening.&#xD;
&#xD;
          -  Respiratory disorders:&#xD;
&#xD;
               -  Asthma, Pre-existing COPD, bronchiectasis or cystic fibrosis&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  Cardiovascular disease:&#xD;
&#xD;
               -  Rhythm disturbances, recent (less than 6 months), angina pectoris cardiac&#xD;
                  insufficiency&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Immunosuppressed patients (other than COVID-19 induced)&#xD;
&#xD;
               -  Primary immune deficiencies such as hypogammaglobulinemia or common variable&#xD;
                  immune deficiency (CVID)&#xD;
&#xD;
               -  Chemotherapy depressing the immune system&#xD;
&#xD;
               -  Immune suppressing medications such as prednisone, Imuran, or TNF inhibitors, or&#xD;
                  anti-rejection transplant drugs.&#xD;
&#xD;
               -  Solid organ transplant&#xD;
&#xD;
          -  Cancer under treatment or within five years (except basocellular skin cancers)&#xD;
&#xD;
          -  Pregnant or breastfeeding women or women unwilling to practice contraception as&#xD;
             outlined in the study protocol for the duration of the study period.&#xD;
&#xD;
          -  Allergy to milk or its derivatives&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Y Desrosiers, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre hospitalier de l'Université de Montréal (CHUM)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier de l'Université de Montréal (CHUM)</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 1P1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>https://www.medrxiv.org/content/10.1101/2021.04.18.21255699v1.full</url>
    <description>Study publication (Pre-print)</description>
  </link>
  <reference>
    <citation>Liu J, Li S, Liu J, Liang B, Wang X, Wang H, Li W, Tong Q, Yi J, Zhao L, Xiong L, Guo C, Tian J, Luo J, Yao J, Pang R, Shen H, Peng C, Liu T, Zhang Q, Wu J, Xu L, Lu S, Wang B, Weng Z, Han C, Zhu H, Zhou R, Zhou H, Chen X, Ye P, Zhu B, Wang L, Zhou W, He S, He Y, Jie S, Wei P, Zhang J, Lu Y, Wang W, Zhang L, Li L, Zhou F, Wang J, Dittmer U, Lu M, Hu Y, Yang D, Zheng X. Longitudinal characteristics of lymphocyte responses and cytokine profiles in the peripheral blood of SARS-CoV-2 infected patients. EBioMedicine. 2020 May;55:102763. doi: 10.1016/j.ebiom.2020.102763. Epub 2020 Apr 18.</citation>
    <PMID>32361250</PMID>
  </reference>
  <reference>
    <citation>Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.</citation>
    <PMID>32192578</PMID>
  </reference>
  <reference>
    <citation>Liu Y, Yan LM, Wan L, Xiang TX, Le A, Liu JM, Peiris M, Poon LLM, Zhang W. Viral dynamics in mild and severe cases of COVID-19. Lancet Infect Dis. 2020 Jun;20(6):656-657. doi: 10.1016/S1473-3099(20)30232-2. Epub 2020 Mar 19. No abstract available.</citation>
    <PMID>32199493</PMID>
  </reference>
  <reference>
    <citation>Shen Z, Xiao Y, Kang L, Ma W, Shi L, Zhang L, Zhou Z, Yang J, Zhong J, Yang D, Guo L, Zhang G, Li H, Xu Y, Chen M, Gao Z, Wang J, Ren L, Li M. Genomic Diversity of Severe Acute Respiratory Syndrome-Coronavirus 2 in Patients With Coronavirus Disease 2019. Clin Infect Dis. 2020 Jul 28;71(15):713-720. doi: 10.1093/cid/ciaa203. Erratum In: Clin Infect Dis. 2021 Dec 16;73(12):2374.</citation>
    <PMID>32129843</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>May 27, 2021</last_update_submitted>
  <last_update_submitted_qc>May 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Nasal irrigation</keyword>
  <keyword>Probiotic</keyword>
  <keyword>Microbiome</keyword>
  <keyword>Lactococcus lactis W136</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>
  </condition_browse>
  <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/NCT04458519
org study id: PROBCO
secondary id: 249512
nct id: NCT04458519
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Randomised, single-blinded trial. Patients with a diagnosis of COVID-19 infection within the
      past 96 hours and not requiring hospitalization will be recruited into a trial of BID Nasal
      irrigation for 14 days, followed by a 14 day observation period. Irrigation will be performed
      with either Probiorinse probiotic nasal irrigation solution or NeilMed Sinus rinse. Patients
      will be able to identify their treatments, but study staff will be blinded as to assignment.
BACKGROUND/OBJECTIVE

      The potential role of the microbiome in COVID-19 disease remains little explored, yert may
      offer an unique therapeutic opportunity for its treatment. Airway inflammation and microbiome
      dysbiosis is present in COVID-19 patients and is related to evolution. The limited
      information on airway inflammation in COVID-19 suggests greater inflammation, as assessed by
      serum markers of inflammation, is associated by more severe disease. Late cell-mediated
      T-cell activation is paradoxically accompanied by TLR expression downregulation, which
      contributes to dysfunctional immune regulation. Individual predisposition to heightened
      inflammatory responses may contribute to this.

      The investigators believe this early TLR downregulation is an important feature of the
      disease, allowing the disease to reproduce unchecked and spread during a prolonged
      asymptomatic shedding period.

      Immune-evasion strategies are common to several viral infections such as influenza,
      respiratory syncytial virus, and human rhinovirus, COVID-19 may exploit this as well.

      Lung microbiome data in COVID-19 is limited, but a small dataset of 8 hospitalised cases has
      been reported from China suggests pulmonary inflammation can be influenced by the microbiome
      at the time of intubation, arguing the need for a more favorable upper airway microbiome.

      Based on the above information, the investigators believe that administration of probiotic
      bacteria directly to the upper airway via irrigation to patients receiving a diagnosis of
      COVID-19 will improve the status of the upper airway microbiome and reduce symptom severity
      and disease in patients with COVID-19 disease not requiring ICU admission or intubation.

      The investigators believe intranasally applied 'health-inducing' bacteria will favorably
      modulate the response to COVID-19 infection, reducing its severity and complications.
      Probiorinse may exert potentially beneficial effects in COVID-19 infection via two potential
      and distinct mechanisms:

        1. Activation of the innate immune system via enhanced TLR signalling:

           - Abundant TLR ligands present on the probiotic bacterial capsule may counter the
           downregulation in TLR expression and function seen with COVID-19 infection.

        2. Promotion of a 'healthy' microbiome profile in the nasopharynx:

             -  Reducing "seeding" the lower respiratory tract with inappropriate bacteria or
                pathogens.

             -  Conditioning inappropriate or excessive immune responses of the airway

      The purpose of this clinical trial is thus to compare the safety and validity of intranasal
      irrigation with Lactococcus lactis W136 with saline nasal irrigation alone in patients with
      mild COVID-19 infection.

      METHODOLOGY

      Consent process in the current context of the COVID-19 pandemic: Verbal consent and
      confirmation of consent in writing or electronically.

      Participants will be recruited via posted signs in the COVID-19 clinic and hospital Intranet
      advertising a research project for individuals diagnosed with COVID-19 infection.

      This study will include three (3) periods, which will take the form of telephone calls /
      email contacts:

        1. Eligibility determination period (Day 0)

        2. Treatment period (Day 1 to Day 14): Probiorinse or Saline solution

        3. Follow-up period (Day 21 and Day 28)

      STATISTICAL ANALYSIS

      Analysis population:

      The primary analysis population for the efficacy endpoints will be the randomized ITT
      population which includes all patients who have been allocated to a randomized treatment
      regardless of whether the treatment kit was used or not. The efficacy analyses will be
      conducted according to the treatment to which they were randomized.

      The analysis population for safety endpoints is defined as all patients exposed to study
      medication, regardless of the amount of treatment administered. The safety analyses will be
      conducted according to the treatment patients actually received. The treatment emergent
      period is defined as the time from the first administration of study medication to Day 14 of
      post treatment period.

      Data Analysis:

      The following null hypothesis and alternative will be tested for the Probiorinse arm against
      NeilMed Sinus Rinse:

        -  H0: No treatment difference between Probiorinse and NeilMed Sinus Rinse.

        -  H1: There is a treatment difference between Probiorinse and NeilMed Sinus Rinse

      Descriptive statistics including number of subjects mean, standard error, and least squares
      (LS) means will be provided. In addition, difference in LS means and the corresponding 95%
      confidence intervals (CI) will be provided along with the p-values.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Single-blinded, randomized, prospective trial
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
masking description: Investigator responsible for product allocation and blinding is not in contact with study participant and will only be made aware of the process of their evolution in case of emergency.
Study personel in daily contact with the patient are unaware of the patient treatment assignement and are thus blinded.
measure: Change in severity of COVID-19 infection
time frame: 4 weeks
description: Change in severity of COVID-19 infection as assessed by number of days with any symptoms of COVID-19 infection greater than or equal to 35 as measured on VAS scale as assessed at the 28 day endpoint.
measure: Number of days with any symptom of anosmia
time frame: 4 weeks
description: Number of days with any symptom of anosmia
measure: Maximal intensity attained in overall assessment of symptoms of COVID-19 infection as measured on Visual Analogue Scale (VAS).
time frame: 4 weeks
description: Maximal intensity attained in overall assessment of symptoms of COVID-19 infection as measured on Visual Analogue Scale (VAS). VAS scale from 0 to 100, with a higher score indicating a worse outcome.
measure: Number of days where rescue medication is required
time frame: 4 weeks
description: Number of days where rescue medication is required
arm group label: Probiorinse
arm group type: Experimental
description: Nasal irrigations with Probiorinse (2.4 Billion CFU (Colony-Forming Units) of Lactococcus Lactis W136, (NPN: 80085895)) twice-daily for a period of fourteen days
arm group label: Saline solution
arm group type: Active Comparator
description: Nasal irrigations with saline (NeilMed Sinus Rinse, (NPN: 80027142)) twice-daily for a period of fourteen days
intervention type: Other
intervention name: Probiorinse
description: Nasal irrigations with probiotic twice-daily for a period of fourteen days
arm group label: Probiorinse
other name: Natural health products
other name: Probiotic
intervention type: Other
intervention name: Saline solution
description: Nasal irrigations with saline-only twice-daily for a period of fourteen days
arm group label: Saline solution
other name: Natural health product
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: No
last name: Martin Y Desrosiers, MD
role: Principal Investigator
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
facility: 
country: Canada
url: https://www.medrxiv.org/content/10.1101/2021.04.18.21255699v1.full
description: Study publication (Pre-print)
citation: Liu J, Li S, Liu J, Liang B, Wang X, Wang H, Li W, Tong Q, Yi J, Zhao L, Xiong L, Guo C, Tian J, Luo J, Yao J, Pang R, Shen H, Peng C, Liu T, Zhang Q, Wu J, Xu L, Lu S, Wang B, Weng Z, Han C, Zhu H, Zhou R, Zhou H, Chen X, Ye P, Zhu B, Wang L, Zhou W, He S, He Y, Jie S, Wei P, Zhang J, Lu Y, Wang W, Zhang L, Li L, Zhou F, Wang J, Dittmer U, Lu M, Hu Y, Yang D, Zheng X. Longitudinal characteristics of lymphocyte responses and cytokine profiles in the peripheral blood of SARS-CoV-2 infected patients. EBioMedicine. 2020 May;55:102763. doi: 10.1016/j.ebiom.2020.102763. Epub 2020 Apr 18.
PMID: 32361250
citation: Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.
PMID: 32192578
citation: Liu Y, Yan LM, Wan L, Xiang TX, Le A, Liu JM, Peiris M, Poon LLM, Zhang W. Viral dynamics in mild and severe cases of COVID-19. Lancet Infect Dis. 2020 Jun;20(6):656-657. doi: 10.1016/S1473-3099(20)30232-2. Epub 2020 Mar 19. No abstract available.
PMID: 32199493
citation: Shen Z, Xiao Y, Kang L, Ma W, Shi L, Zhang L, Zhou Z, Yang J, Zhong J, Yang D, Guo L, Zhang G, Li H, Xu Y, Chen M, Gao Z, Wang J, Ren L, Li M. Genomic Diversity of Severe Acute Respiratory Syndrome-Coronavirus 2 in Patients With Coronavirus Disease 2019. Clin Infect Dis. 2020 Jul 28;71(15):713-720. doi: 10.1093/cid/ciaa203. Erratum In: Clin Infect Dis. 2021 Dec 16;73(12):2374.
PMID: 32129843
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: COVID-19
sharing ipd: No