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| ID | Type | Description | Link |
|---|---|---|---|
| 2023948 | Other Grant/Funding Number | Astellas | |
| 2023158 | Other Grant/Funding Number | CDC |
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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
| Astellas Pharma Inc | INDUSTRY |
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The purpose of this study is to identify the number of individuals with severe CoVID who require ventilator support and who develop serious fungal infections. The study is an observational study, meaning that we are not providing any intervention that does not involve usual standard of care. Our chief goal is to find evidence of fungal infection by using traditional, approved methods of diagnosis, but by applying these methods in the same way and frequency among all study participants. We will be looking especially for evidence of a fungal infection known as Aspergillus, which can causes a serious lung infection called invasive aspergillosis (IA).
COVID-19 is a disease caused by infection with the novel coronavirus SARS-COV2 which emerged in late 2019 in Wuhan, China (1). This illness is associated with viral prodromal symptoms, then subsequently fever, cough, and shortness of breath (1). In a subset of patients, lower respiratory tract infection associated with respiratory failure develops. Among these patients, progression to severe respiratory failure and ARDS requiring ventilator support has occurred in an alarming number of patients at rates that are many-fold higher than what is typically associated with seasonal influenza A or B (2). One of the most feared complications of post-influenza respiratory failure is the development of invasive pulmonary aspergillosis which may occur in as many as 15-20% of those requiring ventilator support (based on European data) (3-6). Among those developing IA following influenza A or B, mortality of 50% or greater is reported (3-6).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID Patients with Aspergillosis and Other fungal Infections | All patients have been diagnosed with COVID-19. The purpose of this study is to look at this group of patients in the potential to develop Aspergillosis and other fungal infections. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation to monitor patients for these infections | Other | We will be receiving discarded specimens weekly. From these we are going to identify these various potential infections. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants requiring mechanical ventilation | Number of patients placed on a ventilator | 72 hours or greater |
| Participants with all cause mortality | Participants with all cause mortality in SARS-CoV-2 | In 30 days |
| Participants with all cause mortality | Participants with all cause mortality in SARS-CoV-2 | In 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Participants at risk for developing CAPA or IFIs | Risk factors associated with patients who are at risk for CAPA or IFIs | 180 days |
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Inclusion Criteria:
Exclusion Criteria:
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Adult Intensive Care Unit Patients with SARS-CoV2 requiring greater than 72 hours of mechanical ventilation.
Participating sites include: University of Alabama at Birmingham, University of Pittsburgh, Washington University in St. Louis, University of California at Davis, University of Texas at Houston, University of Maryland, and University of Texas Health Sciences Center at San Antonio, Cornell University and Columbia/Presbyterian Medical Center
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| Name | Affiliation | Role |
|---|---|---|
| Peter Pappas, MD | The University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D001228 | Aspergillosis |
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Discarded clinical samples from routine testing will be collected and tested for diagnostic purposes on a weekly basis. These will include serum, deep suction specimens, and BAL when available. These samples will be tested for Aspergillus GM, Aspergillus PCR, and Pneumocystis PCR. Specimens will be stored at the CDC biorepository for future diagnostic use.
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001423 | Bacterial Infections and Mycoses |