<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/NCT04496466</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00245545</org_study_id>
    <nct_id>NCT04496466</nct_id>
  </id_info>
  <brief_title>Clinical Characterization Protocol for Severe Infectious Diseases (CCPSEI)</brief_title>
  <acronym>CCPSEI</acronym>
  <official_title>Clinical Characterization Protocol for Severe Infectious Diseases (CCPSEI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</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>
      This is a standardized protocol for the rapid, coordinated clinical investigation of severe&#xD;
      or potentially severe acute infections by severe acute respiratory syndrome coronavirus 2&#xD;
      (SARS-CoV-2). Participants with acute illness suspected to be caused by SARS-CoV-2 (COVID-19)&#xD;
      will be enrolled. This protocol has been designed to enable data and biological samples to be&#xD;
      prospectively collected and shared rapidly in a globally-harmonized sampling schedule.&#xD;
      Multiple independent studies can be easily aggregated, tabulated and analyzed across many&#xD;
      different settings globally. The protocol is the product of many years of discussion among&#xD;
      international investigators from a wide range of scientific and medical. Recruitment under&#xD;
      this protocol has been initiated in response to Middle Eastern Respiratory Syndrome&#xD;
      coronavirus (MERS-CoV) in 2012-2013, Influenza H7N9 in 2013, viral hemorrhagic fever&#xD;
      (Ebolavirus) in 2014, Monkeypox &amp; MERS-coronavirus in 2018, Tick-borne encephalitis virus&#xD;
      (TBEV) in 2019 and COVID-19 in 2020. Participants may be newly identified through healthcare&#xD;
      system or public health access, under quarantine, or in isolation care in outpatient or&#xD;
      inpatient settings relevant to the Johns Hopkins University School of Medicine. Other&#xD;
      locations may adopt this study concurrently, under a deferred review, or cooperatively.&#xD;
&#xD;
      The existence of this protocol would ensure a timely, comprehensive epidemiologic and&#xD;
      clinical characterization of the initial cases of COVID-19 in a mounting pandemic. The World&#xD;
      Health Organization (WHO) recognized the need for standardized data collection for the&#xD;
      epidemiology, immunology and clinical characteristics of these novel pathogens, and&#xD;
      established the International Severe Acute Respiratory and Emerging Infection Consortium&#xD;
      (ISARIC) network in 2011. At the core of the protocol are a standardized schedule, structure&#xD;
      and content of clinical, laboratory and microbiologic data collection, supplemented by&#xD;
      domain-specific components (e.g., acute respiratory infection, viral hemorrhagic fever). The&#xD;
      timepoints of this protocol will also be aligned with a separate multi-center institutional&#xD;
      review board (IRB) approved protocol to describe patients with emerging infectious diseases&#xD;
      that present to military treatment facilities within the United States.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Infectious disease is the single biggest cause of death worldwide. New infectious agents,&#xD;
      such as the SARS, MERS and SARS CoV-2, novel influenza viruses, viruses causing viral&#xD;
      hemorrhagic fever (e.g. Ebola), and viruses that affect the central nervous system (CNS) such&#xD;
      as TBEV &amp; Nipah require investigation to understand pathogen biology and pathogenesis in the&#xD;
      host. Even for known infections, resistance to antimicrobial therapies is widespread, and&#xD;
      treatments to control potentially deleterious host responses are lacking.&#xD;
&#xD;
      In order to develop a mechanistic understanding of disease processes, such that risk factors&#xD;
      for severe illness can be identified and treatments can be developed, it is necessary to&#xD;
      understand pathogen characteristics associated with virulence, the replication dynamics and&#xD;
      in-host evolution of the pathogen, the dynamics of the host response, the pharmacology of&#xD;
      antimicrobial or host-directed therapies, the transmission dynamics, and factors underlying&#xD;
      individual susceptibility.&#xD;
&#xD;
      The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to almost&#xD;
      500,000 cases of COVID-19 and over 22,000 deaths worldwide. There have been 24,738 cases and&#xD;
      291 deaths in the United states and 190 cases in Maryland, USA as of March 21, 2020. The&#xD;
      global is dire, with reports of severe overcrowding in hospitals, shortages of medical&#xD;
      supplies, and insufficient medical personnel to address the surge in patients seeking care.&#xD;
      The risk of this situation occurring in other countries is highlighted by the propensity for&#xD;
      high infectiousness and asymptomatic spread. To protect patients and the community-at-large,&#xD;
      research is urgently needed to guide quarantine and treatment strategies for COVID-19.&#xD;
&#xD;
      Morbidity and mortality from COVID-19 is associated with the development of fulminant&#xD;
      respiratory failure. Recent data suggests death rates as high as 38% among those requiring&#xD;
      ICU care, many of whom developed Acute Respiratory Distress Syndrome (ARDS). However, it is&#xD;
      currently unknown which patients are at risk of severe disease. Diagnostic tools are urgently&#xD;
      needed to detect immunologic and physiologic disease responses to identify infection in&#xD;
      asymptomatic individuals and to identify infections on the trajectory to ARDS. Furthermore,&#xD;
      the infectious reservoirs of SARS CoV-2 remain unclear although children may be important&#xD;
      reservoirs given children's relatively mild disease course as well as prolonged viral&#xD;
      shedding from both respiratory and stool specimens. This protocol aims to address these&#xD;
      critical knowledge gaps and future questions relevant to COVID-19 clinical management.&#xD;
&#xD;
      INPATIENT Enrolled inpatient individuals will have whole blood, 1 RNA tube, serum,&#xD;
      nasopharyngeal (NP) or oropharyngeal (OP) swabs collected at enrollment. Subsequent blood&#xD;
      (whole blood, serum, or plasma) collections solely for research among hospitalized patients&#xD;
      will be a maximum of 10 mL per day. This will generally follow a schedule of day 0/1, 3, 7&#xD;
      and weekly while hospitalized. Subsequent collections after hospital discharge occur at 1&#xD;
      month, 3 months, 6 months, 9 months, and 12 months.&#xD;
&#xD;
      Clinical data from routine clinical care that will be recorded include but are not limited&#xD;
      to:&#xD;
&#xD;
        -  Symptoms&#xD;
&#xD;
        -  Comprehensive medical history&#xD;
&#xD;
        -  Medications&#xD;
&#xD;
        -  Physical exam including vital signs and oxygen administration&#xD;
&#xD;
        -  Clinical and microbiology labs performed during (Complete Blood Count (CBC),&#xD;
           chemistries, lactate, blood culture results, HIV results)&#xD;
&#xD;
        -  Images and/or imaging results from hospital record&#xD;
&#xD;
      OUTPATIENT After enrollment, a shipping coordinator will contact the participant to confirm&#xD;
      participant's willingness to participate and to verify the shipping address to which a study&#xD;
      self-testing kit will be mailed. This kit will contain a thermometer, pulse oximeter, gloves,&#xD;
      NP and OP swabs (for days 0, 3, 7, 14), 4 viral transport media into which the swabs will be&#xD;
      put after testing, Tasso and/or dried blood spot testing kits, Oracol (oral fluid collection&#xD;
      tube).&#xD;
&#xD;
      Participants with confirmed or suspected COVID-19, 18 years of age and older will be followed&#xD;
      with sample self-collection. Sample self-collection will occur on Day 0, which should occur&#xD;
      within 24-48 hours of enrollment. Sample self-collection will also occur on days 3 , 7,&#xD;
      14,(-1/+1) and 28 days (+32). Participants with persistent symptoms will have an additional&#xD;
      collection date at 21 days (-2/+2) if feasible. Participants will be advised to do this by&#xD;
      themselves and not ask others for assistance. A self-testing kit would include clear&#xD;
      instructions for self-collection of samples. This may include respiratory, oral fluid, and&#xD;
      dried blood spot/painless capillary blood collection depending on availability of resources.&#xD;
      Depending on shipping resources, samples will be temporarily stored in the participant's&#xD;
      personal freezer. Vital signs (e.g., heart rate, oxygen saturation, temperature) will be&#xD;
      collected by participants with positive COVID-19 results using devices provided by the study&#xD;
      when resources are available (e.g. portable pulse oximeter and/or thermometer).&#xD;
      Questionnaires for demographic, medical history, socioeconomic, mental health, household&#xD;
      contacts, and housing situation will be administered electronically or by study staff&#xD;
      depending on the study participant's situation. A standard symptom questionnaire will be&#xD;
      administered at every sampling time point either electronically or by study staff including&#xD;
      day 28.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 9, 2020</start_date>
  <completion_date type="Actual">October 31, 2021</completion_date>
  <primary_completion_date type="Actual">October 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of viral shedding</measure>
    <time_frame>3 months</time_frame>
    <description>SARS-CoV-2 Reverse transcription polymerase chain reaction (RT-PCR) and viral culture will be performed on prospectively collected samples to determine presence and Ct of viral RNA and presence or absence of cultivable virus in assessing how long virus is shed (in days).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of comorbidities</measure>
    <time_frame>12 months</time_frame>
    <description>Incidence of comorbidities (chronic kidney disease, lung disease, cardiovascular disease, venous thromboembolism) will be determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment response as assessed by survival</measure>
    <time_frame>1 month</time_frame>
    <description>Survival with the use of treatment with off-label therapeutics or management strategies will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment response as assessed by survival</measure>
    <time_frame>3 months</time_frame>
    <description>Survival with the use of treatment with off-label therapeutics or management strategies will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality of COVID-19</measure>
    <time_frame>12 months</time_frame>
    <description>Survival rates overall will be determined in assessing the mortality of COVID-19.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lung ultrasound score</measure>
    <time_frame>Baseline and 1 month</time_frame>
    <description>Changes in a lung ultrasound score (LUS) over time will be calculated and evaluated for prediction of disease severity defined by the World Health Organization COVID-19 ordinal scale (clinical status on an ordinal scale from 0 to 8 with higher scores meaning worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in immunoglobulin M (IgM) antibody levels in serum</measure>
    <time_frame>Baseline, one month, and every three months up to 12 months</time_frame>
    <description>Change in IgM antibody levels in serum will be determined for description of host response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in immunoglobulin G (IgG) antibody levels in serum</measure>
    <time_frame>Baseline, one month, and every three months up to 12 months</time_frame>
    <description>Change in IgG antibody levels in serum will be determined for description of host response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in immunoglobulin A (IgA) antibody levels in serum</measure>
    <time_frame>Baseline, one month, and every three months up to 12 months</time_frame>
    <description>Change in IgA antibody levels in serum will be determined for description of host response.</description>
  </secondary_outcome>
  <enrollment type="Actual">702</enrollment>
  <condition>Coronavirus</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      As part of a secondary objective, we plan to develop a data and specimen repository that acts&#xD;
      as a resource for the investigation and analysis of downstream research questions specific to&#xD;
      the clinical course of COVID-19, the development of medical countermeasures and diagnostic&#xD;
      tests, and, basic biology questions associated with SARS-CoV-2.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        INPATIENT Confirmed and suspected patients with COVID-19 presenting to a Johns Hopkins&#xD;
        Health System hospital&#xD;
&#xD;
        OUTPATIENT Identification of Potential Participants / Recruitment Persons &gt; age 18 who&#xD;
        received testing for SARS-CoV-2 after attending a Johns Hopkins Health System Testing site.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        INPATIENT&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Newborns to adults 18 years of age or older AND&#xD;
&#xD;
          -  Hospitalized with a suspected or proven infection with SARS-CoV-2.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of a pathogen unrelated to the objectives of this study AND no&#xD;
             indication or likelihood of co-infection with a relevant pathogen. OR&#xD;
&#xD;
          -  Refusal by participant, parent or appropriate representative. OR&#xD;
&#xD;
          -  Individuals with any condition or major comorbidity that the study investigators&#xD;
             believe will compromise the patient's ability to comply with the requirements of the&#xD;
             study.&#xD;
&#xD;
        OUTPATIENT&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Adults 18 years of age or older AND&#xD;
&#xD;
          -  Suspected or proven infection with SARS-CoV-2 pending test results from any Johns&#xD;
             Hopkins Health system testing site including individuals who ultimately test negative&#xD;
             (for use as negative controls.)&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Refusal by participant, parent or appropriate representative. OR&#xD;
&#xD;
          -  Individuals with any condition or major comorbidity that the study investigators&#xD;
             believe will compromise the patient's ability to comply with the requirements of the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Lauren Sauer, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>January 13, 2022</last_update_submitted>
  <last_update_submitted_qc>January 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The COVID-19 Biospecimen Committee evaluates requests from researchers for accessing serum or plasma from COVID-19 patients. The committee's default position will be for investigators to receive premade specimen collections for pilot studies with requests for custom made collections considered after pilot studies are completed.&#xD;
https://ictr.johnshopkins.edu/coronavirus/biospecimencommittee/</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04496466
org study id: IRB00245545
nct id: NCT04496466
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a standardized protocol for the rapid, coordinated clinical investigation of severe
      or potentially severe acute infections by severe acute respiratory syndrome coronavirus 2
      (SARS-CoV-2). Participants with acute illness suspected to be caused by SARS-CoV-2 (COVID-19)
      will be enrolled. This protocol has been designed to enable data and biological samples to be
      prospectively collected and shared rapidly in a globally-harmonized sampling schedule.
      Multiple independent studies can be easily aggregated, tabulated and analyzed across many
      different settings globally. The protocol is the product of many years of discussion among
      international investigators from a wide range of scientific and medical. Recruitment under
      this protocol has been initiated in response to Middle Eastern Respiratory Syndrome
      coronavirus (MERS-CoV) in 2012-2013, Influenza H7N9 in 2013, viral hemorrhagic fever
      (Ebolavirus) in 2014, Monkeypox & MERS-coronavirus in 2018, Tick-borne encephalitis virus
      (TBEV) in 2019 and COVID-19 in 2020. Participants may be newly identified through healthcare
      system or public health access, under quarantine, or in isolation care in outpatient or
      inpatient settings relevant to the Johns Hopkins University School of Medicine. Other
      locations may adopt this study concurrently, under a deferred review, or cooperatively.

      The existence of this protocol would ensure a timely, comprehensive epidemiologic and
      clinical characterization of the initial cases of COVID-19 in a mounting pandemic. The World
      Health Organization (WHO) recognized the need for standardized data collection for the
      epidemiology, immunology and clinical characteristics of these novel pathogens, and
      established the International Severe Acute Respiratory and Emerging Infection Consortium
      (ISARIC) network in 2011. At the core of the protocol are a standardized schedule, structure
      and content of clinical, laboratory and microbiologic data collection, supplemented by
      domain-specific components (e.g., acute respiratory infection, viral hemorrhagic fever). The
      timepoints of this protocol will also be aligned with a separate multi-center institutional
      review board (IRB) approved protocol to describe patients with emerging infectious diseases
      that present to military treatment facilities within the United States.
Infectious disease is the single biggest cause of death worldwide. New infectious agents,
      such as the SARS, MERS and SARS CoV-2, novel influenza viruses, viruses causing viral
      hemorrhagic fever (e.g. Ebola), and viruses that affect the central nervous system (CNS) such
      as TBEV & Nipah require investigation to understand pathogen biology and pathogenesis in the
      host. Even for known infections, resistance to antimicrobial therapies is widespread, and
      treatments to control potentially deleterious host responses are lacking.

      In order to develop a mechanistic understanding of disease processes, such that risk factors
      for severe illness can be identified and treatments can be developed, it is necessary to
      understand pathogen characteristics associated with virulence, the replication dynamics and
      in-host evolution of the pathogen, the dynamics of the host response, the pharmacology of
      antimicrobial or host-directed therapies, the transmission dynamics, and factors underlying
      individual susceptibility.

      The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to almost
      500,000 cases of COVID-19 and over 22,000 deaths worldwide. There have been 24,738 cases and
      291 deaths in the United states and 190 cases in Maryland, USA as of March 21, 2020. The
      global is dire, with reports of severe overcrowding in hospitals, shortages of medical
      supplies, and insufficient medical personnel to address the surge in patients seeking care.
      The risk of this situation occurring in other countries is highlighted by the propensity for
      high infectiousness and asymptomatic spread. To protect patients and the community-at-large,
      research is urgently needed to guide quarantine and treatment strategies for COVID-19.

      Morbidity and mortality from COVID-19 is associated with the development of fulminant
      respiratory failure. Recent data suggests death rates as high as 38% among those requiring
      ICU care, many of whom developed Acute Respiratory Distress Syndrome (ARDS). However, it is
      currently unknown which patients are at risk of severe disease. Diagnostic tools are urgently
      needed to detect immunologic and physiologic disease responses to identify infection in
      asymptomatic individuals and to identify infections on the trajectory to ARDS. Furthermore,
      the infectious reservoirs of SARS CoV-2 remain unclear although children may be important
      reservoirs given children's relatively mild disease course as well as prolonged viral
      shedding from both respiratory and stool specimens. This protocol aims to address these
      critical knowledge gaps and future questions relevant to COVID-19 clinical management.

      INPATIENT Enrolled inpatient individuals will have whole blood, 1 RNA tube, serum,
      nasopharyngeal (NP) or oropharyngeal (OP) swabs collected at enrollment. Subsequent blood
      (whole blood, serum, or plasma) collections solely for research among hospitalized patients
      will be a maximum of 10 mL per day. This will generally follow a schedule of day 0/1, 3, 7
      and weekly while hospitalized. Subsequent collections after hospital discharge occur at 1
      month, 3 months, 6 months, 9 months, and 12 months.

      Clinical data from routine clinical care that will be recorded include but are not limited
      to:

        -  Symptoms

        -  Comprehensive medical history

        -  Medications

        -  Physical exam including vital signs and oxygen administration

        -  Clinical and microbiology labs performed during (Complete Blood Count (CBC),
           chemistries, lactate, blood culture results, HIV results)

        -  Images and/or imaging results from hospital record

      OUTPATIENT After enrollment, a shipping coordinator will contact the participant to confirm
      participant's willingness to participate and to verify the shipping address to which a study
      self-testing kit will be mailed. This kit will contain a thermometer, pulse oximeter, gloves,
      NP and OP swabs (for days 0, 3, 7, 14), 4 viral transport media into which the swabs will be
      put after testing, Tasso and/or dried blood spot testing kits, Oracol (oral fluid collection
      tube).

      Participants with confirmed or suspected COVID-19, 18 years of age and older will be followed
      with sample self-collection. Sample self-collection will occur on Day 0, which should occur
      within 24-48 hours of enrollment. Sample self-collection will also occur on days 3 , 7,
      14,(-1/+1) and 28 days (+32). Participants with persistent symptoms will have an additional
      collection date at 21 days (-2/+2) if feasible. Participants will be advised to do this by
      themselves and not ask others for assistance. A self-testing kit would include clear
      instructions for self-collection of samples. This may include respiratory, oral fluid, and
      dried blood spot/painless capillary blood collection depending on availability of resources.
      Depending on shipping resources, samples will be temporarily stored in the participant's
      personal freezer. Vital signs (e.g., heart rate, oxygen saturation, temperature) will be
      collected by participants with positive COVID-19 results using devices provided by the study
      when resources are available (e.g. portable pulse oximeter and/or thermometer).
      Questionnaires for demographic, medical history, socioeconomic, mental health, household
      contacts, and housing situation will be administered electronically or by study staff
      depending on the study participant's situation. A standard symptom questionnaire will be
      administered at every sampling time point either electronically or by study staff including
      day 28.
observational model: Cohort
time perspective: Prospective
measure: Duration of viral shedding
time frame: 3 months
description: SARS-CoV-2 Reverse transcription polymerase chain reaction (RT-PCR) and viral culture will be performed on prospectively collected samples to determine presence and Ct of viral RNA and presence or absence of cultivable virus in assessing how long virus is shed (in days).
measure: Incidence of comorbidities
time frame: 12 months
description: Incidence of comorbidities (chronic kidney disease, lung disease, cardiovascular disease, venous thromboembolism) will be determined.
measure: Treatment response as assessed by survival
time frame: 1 month
description: Survival with the use of treatment with off-label therapeutics or management strategies will be assessed.
measure: Treatment response as assessed by survival
time frame: 3 months
description: Survival with the use of treatment with off-label therapeutics or management strategies will be assessed.
measure: Mortality of COVID-19
time frame: 12 months
description: Survival rates overall will be determined in assessing the mortality of COVID-19.
measure: Change in lung ultrasound score
time frame: Baseline and 1 month
description: Changes in a lung ultrasound score (LUS) over time will be calculated and evaluated for prediction of disease severity defined by the World Health Organization COVID-19 ordinal scale (clinical status on an ordinal scale from 0 to 8 with higher scores meaning worse outcome).
measure: Change in immunoglobulin M (IgM) antibody levels in serum
time frame: Baseline, one month, and every three months up to 12 months
description: Change in IgM antibody levels in serum will be determined for description of host response.
measure: Change in immunoglobulin G (IgG) antibody levels in serum
time frame: Baseline, one month, and every three months up to 12 months
description: Change in IgG antibody levels in serum will be determined for description of host response.
measure: Change in immunoglobulin A (IgA) antibody levels in serum
time frame: Baseline, one month, and every three months up to 12 months
description: Change in IgA antibody levels in serum will be determined for description of host response.
As part of a secondary objective, we plan to develop a data and specimen repository that acts
      as a resource for the investigation and analysis of downstream research questions specific to
      the clinical course of COVID-19, the development of medical countermeasures and diagnostic
      tests, and, basic biology questions associated with SARS-CoV-2.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Lauren Sauer, MS
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Communicable Diseases
mesh term: Infections
sharing ipd: No
ipd description: The COVID-19 Biospecimen Committee evaluates requests from researchers for accessing serum or plasma from COVID-19 patients. The committee's default position will be for investigators to receive premade specimen collections for pilot studies with requests for custom made collections considered after pilot studies are completed.
https://ictr.johnshopkins.edu/coronavirus/biospecimencommittee/