Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06202521
Status:
RECRUITING
Last Update Posted:
2024-01-11
First Post:
2024-01-01
Brief Title:
CX-4945 in Viral Community Acquired Pneumonia
Sponsor:
Senhwa Biosciences Inc
Organization:
Senhwa Biosciences Inc
Study Overview
Official Title:
Evaluation of the Safety and Efficacy of Silmitasertib CX-4945 in Combination with Standard of Care SOC for Treating Patients with Community-Acquired Pneumonia CAP Associated with SARS-CoV-2 and Influenza Viral Infections
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase II multi-center double-blind randomized interventional study in approximately 120 subjects to evaluate clinical benefit of CX-4945 in adult outpatients with SARS-CoV-2 and influenza viral infection-associated pneumonia The subjects will be recruited into two domains including SARS-CoV-2 and influenza virus domains The study will compare the efficacy of Standard of Care SOC combined with CX-4945 against SOC paired with a placebo utilizing a 11 allocation ratio in each domain
Detailed Description:
Domain I SARS-CoV-2 domain
Arm 1 CX-4945 400 mg BID for 5 days SOC
Arm 2 Placebo SOC
Domain II Influenza virus domain
Arm 3 CX-4945 400 mg BID for 5 days SOC
Arm 4 Placebo SOC
Screening visit will collect health information and perform protocol specified tests to determine patients eligibility After screening visit eligible subjects who fulfill all selection criteria for enrollment will be randomized into each of the arms The CX-4945 will be administered at 400 mg BID for 5 days Subjects will be followed up until Day 29
Arm 1 CX-4945 400 mg BID for 5 days SOC
Arm 2 Placebo SOC
Domain II Influenza virus domain
Arm 3 CX-4945 400 mg BID for 5 days SOC
Arm 4 Placebo SOC
Screening visit will collect health information and perform protocol specified tests to determine patients eligibility After screening visit eligible subjects who fulfill all selection criteria for enrollment will be randomized into each of the arms The CX-4945 will be administered at 400 mg BID for 5 days Subjects will be followed up until Day 29
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?:
True
Is an FDA AA801 Violation?:
None