Clinical Trials Logo

Clinical Trial 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 1:1 allocation ratio in each domain.


Clinical Trial 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 After screening visit, eligible subjects who fulfill all selection criteria for enrollment will be randomized into each of the arms. CX-4945 will be administered at 400 mg BID for up to 5 days. After treatment phase, subjects will be followed up for 28 days. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06202521
Study type Interventional
Source Senhwa Biosciences, Inc.
Contact Becky Lin
Phone +886-2-8911-9856
Email beckylin@senhwabio.com
Status Not yet recruiting
Phase Phase 2
Start date March 2024
Completion date June 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05722938 - Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP) Phase 3
Terminated NCT04972318 - Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia N/A
Recruiting NCT06065618 - Characteristics of Hospitalized Patients With Community-acquired Pneumonia
Not yet recruiting NCT03675178 - Clinical Study of Anerning Particle for the Treatment of Childhood Community-acquired Pneumonia Phase 4
Not yet recruiting NCT04166110 - Antibiotic Therapy In Respiratory Tract Infections N/A
Completed NCT02380352 - Short-course Antimicrobial Therapy for Paediatric Respiratory Infections Phase 4
Completed NCT01671280 - Drug Use Investigation Of Azithromycin IV For Community-Acquired Pneumonia Or Pelvic Inflammatory Disease (Regulatory Post Marketing Commitment Plan) N/A
Completed NCT02555852 - Proton Pump Inhibitors and Risk of Community-acquired Pneumonia N/A
Recruiting NCT00752947 - Efficacy and Safety Trial to Assess Moxifloxacin in Treating Community-Acquired Pneumonia (CAP) With Aspiration Factors Phase 4
Completed NCT00140023 - Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia Phase 3
Recruiting NCT04089787 - Shortened Antibiotic Treatment of 5 Days in Community-Acquired Pneumonia Phase 4
Completed NCT05356494 - Postural Drainage and PEP Technique in Community Acquired Pneumonia N/A
Completed NCT05133752 - Oral Nemonoxacin in Treating Elderly Patients With CAP Phase 4
Not yet recruiting NCT06291012 - Stopping Pneumonia Antibiotherapy Regimen Early Phase 4
Recruiting NCT05002192 - A Retrospective, Real-world Study of ELP Used in the Expectorant Treatment of Community-acquired Pneumonia
Completed NCT03452826 - Combined Use of a Respiratory Broad Panel mPCR and Procalcitonin to Reduce Duration of Antibiotics Exposure in Patients With Severe Community-Acquired Pneumonia N/A
Terminated NCT04071041 - Effect of Albumin Administration in Hypoalbuminemic Hospitalized Patients With Community-acquired Pneumonia. Phase 3
Completed NCT03474991 - KIDS-STEP_Betamethasone Therapy in Hospitalised Children With CAP Phase 3
Withdrawn NCT01662258 - Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP N/A
Completed NCT01683487 - Delayed Antibiotic Treatment in Community-acquired Pneumococcal Pneumonia. Phase 4