Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients (POSACOVID)

Medical University of Graz

Status: Completed

Conditions: COVID-19 Respiratory Infection; Aspergillosis

Treatments: Drug: Posaconazole

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05065658

32-296 ex 19/20

Details and patient eligibility

About

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.

Enrollment: 249 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patient (> 18 years)
• PCR (polymerase chain reaction) -confirmed SARS-CoV-2 infections based on nasopharyngeal swab (NPS), oropharyngeal swab (OPS), tracheal aspirate (TA), bronchial aspirate (BA), or bronchoalveolar lavage fluid (BALF) within 14 days prior to ICU admission or within 72 hours following ICU admission due to severe COVID-19 infection
• Radiographic imaging consistent with SARS-CoV-2 infection (e.g. atypical pneumonia, organizing pneumonia, ground glass opacities) or ARDS within 7 days of diagnosis of SARS-CoV-2 infection

Exclusion criteria

• Patients with a diagnosis of invasive aspergillosis/detection of Aspergillus spp. by culture from sputum, TA, BA, or BALF or positive GM from serum, TA, or BALF at baseline (=ICU admission)
• History of invasive aspergillosis within the prior six months
• Patients that are being treated with mold-active antifungal agents for invasive aspergillosis or another invasive fungal infection
• Patients that are being treated with mold-active antifungal agents for invasive aspergillosis or another invasive fungal infection
• Death or transfer to general ward within 48 hours of ICU admission
• Antifungal prophylaxis other than posaconazole (e.g. inhaled amphotericin B)

Trial design

249 participants in 2 patient groups

Critically-ill COVID-19 patients receiving posaconazole prophylaxis

Treatment:

Drug: Posaconazole

Critically-ill COVID-19 patients without antifungal prophylaxis