Experimental drug aims to keep viral pneumonia patients out of hospital
NCT ID NCT06202521
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 trial tested the drug silmitasertib (CX-4945) plus standard care in adults with pneumonia caused by COVID-19 or influenza. The goal was to see if the drug could reduce the need for hospitalization or prevent death. The study planned to enroll 120 people but was terminated early after enrolling 45. Participants took the drug or a placebo twice daily for up to 5 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- silmitasertib (CX-4945)
- What this could lead to
- If it worked, this could point toward a new treatment to prevent hospitalization and death from viral pneumonia caused by COVID-19 or flu.
- What could go wrong
- The trial was terminated early with only 45 participants, so results are limited. It is a Phase 2 study, meaning it is still early and may not show clear benefit or safety.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
45 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Apr 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria 1. Not currently hospitalized 2. Males or females aged ≥ 18 years at the time of signing the informed consent form (ICF) 3. 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) 4. With a pneumonia severity index (PSI) of risk class II or III 5. Oxygen saturation measured by pulse oximetry (SpO2) ≥ 94% on room air at sea level 6. 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) 7. Confirmed lower respiratory tract infection by X-ray 8. 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 Notes: Acceptable contraceptive methods include: * Established use of oral, injected or implanted hormonal methods of contraception * Placement of an intrauterine device (IUD) or intrauterine system (IUS) * Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) 9. The participant (or legal representative) agrees and is able to adhere to study protocol-stated requirements, instructions, and restrictions in the investigator's judgement. Furthermore, the participant is capable of understanding and has signed the IRB-approved Informed Consent Form (ICF) 10. With at least two of the risk factors listed below: Age ≥ 50 years-old; cancer and a life expectancy of ≥ 6 months; HIV infection; immunocompromised patient; congestive heart failure (CHF), or coronary artery disease (CAD), or cardiomyopathies; chronic kidney disease (CKD); chronic liver disease; chronic lung disease; diabetes mellitus (DM); body mass index (BMI) \> 25 kg/m2; asthma; cerebrovascular disease; cystic fibrosis; dementia; or current and former smoker Exclusion Criteria 1. Subject received investigational treatment within 30 days prior to the study, or concurrent use of another investigational drug 2. Subject has a history of severe renal disease (required phosphate binders or dialysis) 3. Subject has chronic diarrhea, characterized by three or more loose stools daily for a minimum of four weeks 4. High likelihood of mortality within the next 48 hours, as assessed by the investigator 5. Subject showing signs of respiratory failure and mechanical ventilation is required 6. Subject with liver cirrhosis 7. 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 8. Known active tuberculosis 9. Current documented bacterial infection 10. Subject has a documented anaphylactic reaction, regardless of cause 11. Subject who has taken an antiviral agent against respiratory viral infection for a continuous duration of more than 24 hours before screening 12. Subject is with active gastrointestinal diseases including gastritis, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis 13. Subjects received warfarin within 14 days prior to screening or intend to during the screening or treatment phase 14. History of allergic reactions to any of the ingredients or components used in the manufacture of CX-4945 15. Women who are pregnant or breastfeeding, or planning pregnancy during the study Note: Men and women of reproductive potential must commit to effective contraception methods or abstinence during the study. Any resulting pregnancies or suspected pregnancies must be reported to the treating physician immediately. 16. ALT or AST levels \> 5 times upper limit of normal (ULN) 17. eGFR \<30 mL/min/1.73m2 (calculated by the MDRD formula) 18. Absolute neutrophil count (ANC) \<1000/μL 19. Have received treatment with a SARS-CoV-2 specific monoclonal antibody 20. Have received convalescent COVID-19 plasma treatment 21. Concurrent use of baricitinib 22. Any physical findings or illness history that may compromise study results or increase patient risk, as determined by the investigator
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Far Eastern Memorial Hospital
New Taipei City, Taiwan
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Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
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National Taiwan University Cancer Center, National Taiwan University Hospital
Taipei, Taiwan
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National Taiwan University Hospital
Taipei, Taiwan
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Taichung Veterans General Hospital
Taichung, Taiwan
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Taoyuan General Hospital, Ministry of Health and Welfare
Taoyuan, Taiwan
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Tri-Service General Hospital
Taipei, Taiwan
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