TerminatedPhase 2

CX-4945 in Viral Community Acquired Pneumonia

Stopped: The trial ended early in March 2025 due to changes in disease epidemiology, affecting patient availability and recruitment feasibility.

Taiwan45 participantsStarted 2024-03-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Not currently hospitalized
✓. Males or females aged ≥ 18 years at the time of signing the informed consent form (ICF)
✓. Patients diagnosed with viral pneumonia, as determined by the investigator, who exhibit any of the subsequent criteria: presence of respiratory symptoms or fever (ear temperature ≥ 38 °C, base of the tongue temperature ≥ 37.5 °C, or axillary temperature ≥ 37 °C)
✓. With a pneumonia severity index (PSI) of risk class II or III
✓. Oxygen saturation measured by pulse oximetry (SpO2) ≥ 94% on room air at sea level
✓. Positive test for SARS-CoV-2 or influenza virus infection, confirmed by rapid diagnostic test (excluding cases where both SARS-CoV-2 and influenza virus are positive)
✓. Confirmed lower respiratory tract infection by X-ray
✓. At screening, subjects capable of childbearing must provide a negative serum or urine pregnancy test. These subjects must also commit to adhering to the study-specified contraceptive methods throughout the study duration

Exclusion criteria

What they're measuring

The Percentage of Subjects Requiring Hospitalization, Including Emergency Room Visits, or Resulting in Death Due to Progression of CAP Related to SARS-CoV-2 or Influenza.

Timeframe: Day 1 to Day 29

Trial details

NCT IDNCT06202521

SponsorSenhwa Biosciences, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-22

Results submitted2025-11-14

View on ClinicalTrials.gov More Community-acquired Pneumonia trials