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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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COVID-19 associated pulmonary aspergillosis (CAPA) is considered a potentially life-threatening infection in critically ill COVID (Corona Virus disease)-19 patients. This study will investigate the efficacy of mold-active prophylaxis with posaconazole for patients with severe SARS (severe acute respiratory syndrome)-CoV-2 infection admitted to the ICU (intensive care unit) in a multi-center case-control study in Europe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Critically-ill COVID-19 patients receiving posaconazole prophylaxis |
| ||
| Critically-ill COVID-19 patients without antifungal prophylaxis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posaconazole | Drug | Intravenous posaconazole prophylaxis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of COVID-19 Associated Pulmonary Aspergillosis (CAPA) | Compare the incidence of CAPA at time of discharge from the ICU in those who received posaconazole compared to controls who did not | ICU admission to ICU discharge. On average 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Risk Factors for CAPA Development (EORTC/MSGERC) | This Outcome Measure examines whether the presence of an EORTC/MSGERC-defined risk factor at ICU admission is associated with an increased risk of developing COVID-19-associated pulmonary aspergillosis (CAPA) during the ICU stay. The analysis is conducted using a cohort of patients admitted to the ICU, tracking the development of CAPA from ICU admission to ICU discharge. For this purpose, the number of subjects who had underlying EORTC/MSGERC risk factors present at ICU admission was collected and used as a parameter in a multivariate logistic model to assess the association with an increased risk for CAPA development. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be comprised of patients admitted to the ICU because of severe SARS-CoV-2 infections, who are requiring mechanical ventilation and receive dexamethasone as part of their COVID-19 ARDS treatment in medical centers in i) Graz, Austria (cases), and ii) Genoa, Italy, and iii) Rennes, France (all controls).
Posaconazole prophylaxis for ICU patients with severe COVID-19 requiring ICU admission due to ARDS has been introduced in Graz in July 2020, and cases from Graz will be matched with controls from Rennes and Genoa (matching for days on mechanical ventilation at baseline, Apache II score, age, dexamethasone dosage, and underlying disease).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | Styria | 8036 | Austria | ||
| University of Rennes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39800852 | Derived | Prattes J, Giacobbe DR, Marelli C, Signori A, Dettori S, Cattardico G, Hatzl S, Reisinger AC, Eller P, Krause R, Reizine F, Bassetti M, Gangneux JP, Hoenigl M. Posaconazole for Prevention of COVID-19-Associated Pulmonary Aspergillosis in Mechanically Ventilated Patients: A European Multicentre Case-Control Study (POSACOVID). Mycoses. 2025 Jan;68(1):e70023. doi: 10.1111/myc.70023. |
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| ID | Title | Description |
|---|---|---|
| FG000 | COVID-19 Patients With Acute Respiratory Failure Receiving Posaconazole Prophylaxis (Center 1) | Cases: Intravenous posaconazole prophylaxis |
| FG001 | COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 2) | Controls: Standard of care (no antifungal prophylaxis) |
| FG002 | COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 3) | Controls: Standard of care (no antifungal prophylaxis) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | COVID-19 Patients With Acute Respiratory Failure Receiving Posaconazole Prophylaxis (Center 1) | Cases: Subjects with COVID-19 associated ARF who received intravenous posaconazole prophylaxis upon ICU admission in addition to standard of care treatment |
| BG001 | COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of COVID-19 Associated Pulmonary Aspergillosis (CAPA) | Compare the incidence of CAPA at time of discharge from the ICU in those who received posaconazole compared to controls who did not | Posted | Number | Cases per 1000 ICU days | ICU admission to ICU discharge. On average 20 days |
|
From ICU admission to Day 90
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | COVID-19 Patients With Acute Respiratory Failure Receiving Posaconazole Prophylaxis (Center 1) | Cases: Subjects with COVID-19 associated ARF who received intravenous posaconazole prophylaxis upon ICU admission in addition to standard of care treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Juergen Prattes | Medical University of Graz | 004331638530046 | juergen.prattes@medunigraz.at |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 5, 2024 | Dec 5, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 24, 2023 | Oct 7, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001228 | Aspergillosis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C101425 | posaconazole |
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| ICU admission to ICU discharge. On average 20 days |
| Risk Factors for CAPA Development (ECMO) | This Outcome Measure examines whether the need for extracorporal membrange oxygenation (ECMO) treatment during ICU admission is associated with an increased risk of developing COVID-19-associated pulmonary aspergillosis (CAPA) during the ICU stay. The analysis is conducted using a cohort of patients admitted to the ICU, tracking the development of CAPA from ICU admission to ICU discharge. For this purpose, the number of subjects who required ECMO treatment during ICU stay was collected and used as a parameter in a multivariate logistic model to assess the association with an increased risk for CAPA development. | ICU admission to ICU discharge. On average 20 days |
| Rennes |
| 35033 |
| France |
| San Martino Polyclinic Hospital IRCCS | Genova | 16132 | Italy |
Controls: Subjects with COVID-19 associated ARF who did not receive antifungal prophylaxis in addition to standard of care treatment |
| BG002 | COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 3) | Controls: Subjects with COVID-19 associated ARF who did not receive antifungal prophylaxis in addition to standard of care treatment |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race data were not collected | Race data were not collected | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Tocilizumab Treatment | Count of Participants | Participants |
|
| Systemic glucocorticoid treatment | Count of Participants | Participants |
|
| OG002 | COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 3) | Controls: Subjects with COVID-19 associated ARF who did not receive antifungal prophylaxis in addition to standard of care treatment |
|
|
| Secondary | Risk Factors for CAPA Development (EORTC/MSGERC) | This Outcome Measure examines whether the presence of an EORTC/MSGERC-defined risk factor at ICU admission is associated with an increased risk of developing COVID-19-associated pulmonary aspergillosis (CAPA) during the ICU stay. The analysis is conducted using a cohort of patients admitted to the ICU, tracking the development of CAPA from ICU admission to ICU discharge. For this purpose, the number of subjects who had underlying EORTC/MSGERC risk factors present at ICU admission was collected and used as a parameter in a multivariate logistic model to assess the association with an increased risk for CAPA development. | Posted | Count of Participants | Participants | ICU admission to ICU discharge. On average 20 days |
|
|
|
| Secondary | Risk Factors for CAPA Development (ECMO) | This Outcome Measure examines whether the need for extracorporal membrange oxygenation (ECMO) treatment during ICU admission is associated with an increased risk of developing COVID-19-associated pulmonary aspergillosis (CAPA) during the ICU stay. The analysis is conducted using a cohort of patients admitted to the ICU, tracking the development of CAPA from ICU admission to ICU discharge. For this purpose, the number of subjects who required ECMO treatment during ICU stay was collected and used as a parameter in a multivariate logistic model to assess the association with an increased risk for CAPA development. | Posted | Count of Participants | Participants | ICU admission to ICU discharge. On average 20 days |
|
|
|
| 60 |
| 83 |
| 83 |
| 83 |
| 0 |
| 83 |
| EG001 | COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 2) | Controls: Subjects with COVID-19 associated ARF who did not receive antifungal prophylaxis in addition to standard of care treatment | 14 | 83 | 83 | 83 | 0 | 83 |
| EG002 | COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 3) | Controls: Subjects with COVID-19 associated ARF who did not receive antifungal prophylaxis in addition to standard of care treatment | 38 | 83 | 83 | 83 | 0 | 83 |
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| Male |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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