COVID-19 Associated Pulmonary Aspergillosis (CAPA) and Other Invasive Fungal Infections (IFI)

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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COVID-19 Associated Pulmonary Aspergillosis (CAPA) and Other Invasive Fungal Infections (IFI)

Conditions
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Covid19, Aspergillosis, Fungal Infection

Intervention / Treatment
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* Other: Observation to monitor patients for these infections


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 18 years or older at the time of enrollment SARS-COV2 positivity by PCR with respiratory failure requiring mechanical ventilation for at least 72 hours Prior therapy with antifungals, including prophylaxis, is NOT an exclusion. Exclusion Criteria: Life expectancy of less than 72 hours as determined by the site investigator. Expected to be weaned from mechanical ventilation in next 24 hours Care received in any setting other than an intensive care unit (ICU) at the time of enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID Patients with Aspergillosis and Other fungal Infections<br>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. | Other: Observation to monitor patients for these infections<br>* We will be receiving discarded specimens weekly. From these we are going to identify these various potential infections.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID19, Aspergillosis, Fungal, CAPA