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Experimental drug aims to keep viral pneumonia patients out of hospital

NCT ID NCT06202521

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Mar 2024

Finished

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

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

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

  • Far Eastern Memorial Hospital

    New Taipei City, Taiwan

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, Taiwan

  • National Taiwan University Cancer Center, National Taiwan University Hospital

    Taipei, Taiwan

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Taichung Veterans General Hospital

    Taichung, Taiwan

  • Taoyuan General Hospital, Ministry of Health and Welfare

    Taoyuan, Taiwan

  • Tri-Service General Hospital

    Taipei, Taiwan

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