CX-4945 in Viral Community Acquired Pneumonia (NCT06202521) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before it finished — can you tell me why it was stopped early, and what that means for the safety and usefulness of any data that was collected?
2The trial was studying CX-4945 specifically for viral pneumonia caused by SARS-CoV-2 or influenza — given my diagnosis, does the type of infection I have even match what this trial was designed to treat?
3Since this is a Phase 2 trial that didn't complete, we don't have full evidence yet on whether CX-4945 actually reduces hospitalizations or death — what standard treatments are already proven to work for my situation that I should consider first?
4Because the trial is terminated and no longer enrolling, is there any way to access CX-4945 through a compassionate use or expanded access program, and do you think that would even be appropriate for my case?
5Are there other active trials studying similar approaches for viral community-acquired pneumonia that you think might be worth looking into as an alternative to this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
. 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
. Subject received investigational treatment within 30 days prior to the study, or concurrent use of another investigational drug
. Subject has a history of severe renal disease (required phosphate binders or dialysis)
. Subject has chronic diarrhea, characterized by three or more loose stools daily for a minimum of four weeks
. High likelihood of mortality within the next 48 hours, as assessed by the investigator
. Subject showing signs of respiratory failure and mechanical ventilation is required
. Subject with liver cirrhosis
. Subject with hepatitis B and/or hepatitis C disease, unless the subject has an aspartate aminotransferase (AST) level ranging from 8 to 31 U/L and an alanine aminotransferase (ALT) level from 0 to 41 U/L