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| Name | Class |
|---|---|
| Dialysis Clinic, Inc. | INDUSTRY |
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This is a prospective longitudinal census study conducted at a single center (DCI Inc., Henry Avenue, Philadelphia). The purpose of this study is to gain information about COVID-19 infection and antibody response in an in-center dialysis population. The investigators hypothesize that screening and surveillance for COVID-19 positive test (viral infection) and antibodies response to infection (potential immunity) in a dialysis center population within a high-prevalence region can provide foundational information to guide approaches toward prevention of COVID-19 related illness in a susceptible population. Participants will be given a questionnaire initially and monthly over the study period to find out whether they have had COVID-19 infection, hospitalization, or symptoms. A nasopharyngeal swab test for COVID-19 infection and a blood sample for COVID-19 antibody will be collected monthly for the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Cohort | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 RT-PCR Assay for Detection of COVID-19 Infection | Diagnostic Test | COVID-19 infection and antibody testing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of COVID-19 infection in the cohort | COVID-19 infection assessed using the Hologic Aptima SARS-CoV-2 Assay and/or the Luminex NxTAG SARS-CoV-2 Extended Panel | monthly through study completion (average of 18 months) |
| Link the presence of COVID-19 infection to COVID-19 antibody formation (seroconversion) from qualitative testing | Antibody formation assessed using the Beckman Coulter Access SARS-CoV-2 IgG Antibody Test | monthly through study completion (average of 18 months) |
| Incidence of COVID-19 reinfection | COVID-19 infection assessed using the Hologic Aptima SARS-CoV-2 Assay and/or the Luminex NxTAG SARS-CoV-2 Extended Panel | monthly through study completion (average of 18 months) |
| Presence of antibodies in cases of reinfection | Antibody formation assessed using the Beckman Coulter Access SARS-CoV-2 IgG Antibody Test | monthly through study completion (average of 18 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Avrum Gillespie, MD | Temple University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dialysis Clinic, Inc. | Philadelphia | Pennsylvania | 19129 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |