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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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21217