Status:

COMPLETED

Clinical Characterization Protocol for Severe Infectious Diseases (CCPSEI)

Lead Sponsor:

Johns Hopkins University

Conditions:

Coronavirus

Eligibility:

All Genders

Brief Summary

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). Part...

Detailed Description

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. ...

Eligibility Criteria

Inclusion

  • INPATIENT
  • Inclusion criteria:
  • Newborns to adults 18 years of age or older AND
  • Hospitalized with a suspected or proven infection with SARS-CoV-2.
  • Exclusion criteria:
  • Confirmed diagnosis of a pathogen unrelated to the objectives of this study AND no indication or likelihood of co-infection with a relevant pathogen. OR
  • Refusal by participant, parent or appropriate representative. OR
  • Individuals with any condition or major comorbidity that the study investigators believe will compromise the patient's ability to comply with the requirements of the study.
  • OUTPATIENT
  • Inclusion criteria:
  • Adults 18 years of age or older AND
  • Suspected or proven infection with SARS-CoV-2 pending test results from any Johns Hopkins Health system testing site including individuals who ultimately test negative (for use as negative controls.)
  • Exclusion criteria:
  • Refusal by participant, parent or appropriate representative. OR
  • Individuals with any condition or major comorbidity that the study investigators believe will compromise the patient's ability to comply with the requirements of the study.

Exclusion

    Key Trial Info

    Start Date :

    April 9 2020

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    October 31 2021

    Estimated Enrollment :

    702 Patients enrolled

    Trial Details

    Trial ID

    NCT04496466

    Start Date

    April 9 2020

    End Date

    October 31 2021

    Last Update

    January 14 2022

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Johns Hopkins Hospital

    Baltimore, Maryland, United States, 21217