Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04707703
Status:
TERMINATED
Last Update Posted:
2022-11-25
First Post:
2021-01-08
Brief Title:
Isavuconazole for the Prevention of COVID-19-associated Pulmonary Aspergillosis
Sponsor:
Jeffrey Jenks MD MPH
Organization:
University of California San Diego
Study Overview
Official Title:
Isavuconazole for the Prevention of SARS-CoV-2-associated Invasive Aspergillosis in Critically-Ill Patients
Status:
TERMINATED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Participant enrollment challenges
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Isavu-CAPA
Brief Summary:
The objective of this study is to evaluate whether antifungal prophylaxis with isavuconazole can reduce the incidence of SARS-CoV-2-associated invasive aspergillosis in patients in the ICU intensive care unit with severe COVID-19 infection
The investigators will perform an interventional double-blinded randomized-controlled multi-center study in patients with severe COVID-19 infection admitted to the ICU Patients will be randomized to the isavuconazole prophylaxis plus standard of care SOC group or the placebo plus SOC group Participants will receive isavuconazole or placebo for up to 28 days or until discharge from the hospital whichever occurs first
The investigators will perform an interventional double-blinded randomized-controlled multi-center study in patients with severe COVID-19 infection admitted to the ICU Patients will be randomized to the isavuconazole prophylaxis plus standard of care SOC group or the placebo plus SOC group Participants will receive isavuconazole or placebo for up to 28 days or until discharge from the hospital whichever occurs first
Detailed Description:
Adult patients with polymerase chain reaction PCR-confirmed SARS-CoV-2 COVID-19 infection without a diagnosis of invasive aspergillosis who are hospitalized in the ICU are eligible for inclusion in this study and will be randomized to the isavuconazole plus standard of care SOC group or placebo plus SOC group
If randomized to the isavuconazole group participants will receive intravenous isavuconazonium sulfate 372 mg every 8 hours for 6 doses followed by intravenous isavuconazonium sulfate 372 mg once daily for up to 28 days If randomized to the placebo group participants will receive intravenous placebo every 8 hours for 6 doses followed by once daily for up to 28 days Both groups will receive the usual SOC
Following randomized to the two treatment arms participants will be screened for invasive aspergillosis with thrice weekly fungal cultures from tracheal aspirate TA secretions or thrice weekly serum galactomannan GM testing if TA unable to be performed contraindicated or participant is not intubated If invasive aspergillosis or other invasive fungal infection is detected antifungal therapy will be initiated if the participant is in the placebo arm or modified if needed if the participant is in the isavuconazole arm
If randomized to the isavuconazole group participants will receive intravenous isavuconazonium sulfate 372 mg every 8 hours for 6 doses followed by intravenous isavuconazonium sulfate 372 mg once daily for up to 28 days If randomized to the placebo group participants will receive intravenous placebo every 8 hours for 6 doses followed by once daily for up to 28 days Both groups will receive the usual SOC
Following randomized to the two treatment arms participants will be screened for invasive aspergillosis with thrice weekly fungal cultures from tracheal aspirate TA secretions or thrice weekly serum galactomannan GM testing if TA unable to be performed contraindicated or participant is not intubated If invasive aspergillosis or other invasive fungal infection is detected antifungal therapy will be initiated if the participant is in the placebo arm or modified if needed if the participant is in the isavuconazole arm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None