InfluenzaPhase 3CAPSTONE-IFVNCT07351500
Adaptive RCT of Corticosteroids for Severe Influenza Pneumonia in Adults
A Phase 3 study testing Saline (0.9%, sterile, for infusion), low dose Methylprednisolone and Moderate dose Methylprednisolone in people with Influenza, run by Qingyuan Zhan.
Trial summary
Severe community-acquired pneumonia caused by influenza virus (hereafter referred to as severe influenza pneumonia) is a major etiology of community-acquired pneumonia leading to acute respiratory failure and ICU admission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- Saline (0.9%, sterile, for infusion), low dose Methylprednisolone and Moderate dose Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 496 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2026to 30 Nov 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Admission to the Intensive Care Unit (ICU).
- Meeting the diagnostic criteria for community-acquired pneumonia (CAP).
- Meeting at least one of the major diagnostic criteria for severe pneumonia:
- Requirement for endotracheal intubation and mechanical ventilation;
- Septic shock requiring vasopressor therapy after adequate fluid resuscitation.
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- -Or simultaneously fulfilling three of the minor criteria:
- Respiratory rate ≥ 30 breaths/min;
- PaO₂/FiO₂ ≤ 250 mmHg;
- Multilobar infiltrates;
- Altered mental status and/or disorientation;
- Blood urea nitrogen ≥ 20 mg/dL (7.12 mmol/L);
- Leukopenia (white blood cell count < 4 × 10⁹/L);
- Thrombocytopenia (platelet count < 100 × 10⁹/L);
- Hypothermia (core temperature < 36 °C);
- Hypotension (systolic blood pressure < 90 mmHg) requiring aggressive fluid resuscitation.
- Confirmed influenza virus etiology: at least one positive nucleic acid test (RT-PCR/PCR) or next-generation sequencing (NGS) result for influenza virus in respiratory specimens (respiratory secretions, throat swabs, or bronchoalveolar lavage fluid).
- Severe community-acquired pneumonia (SCAP) patients admitted to the emergency department/ward/ICU due to respiratory failure within < 72 hours.
- Signed informed consent.
Who cannot join
- Patients receiving vasopressor therapy for septic shock at the time of enrollment.
- Terminally ill patients (expected survival <30 days, e.g., advanced malignancy).
- Clinical history suggesting overt aspiration.
- Documented active gastrointestinal bleeding.
- Presence of cystic fibrosis, obstructive pneumonia, active influenza, pulmonary tuberculosis, or fungal infection.
- Active viral hepatitis or active herpesvirus infection.
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- Bone marrow suppression or HIV infection.
- Refusal of mechanical ventilation and endotracheal intubation.
- Uncontrolled hyperglycemia (diabetic ketoacidosis with blood ketones >3 mmol/L, or hyperosmolar hyperglycemic state with blood glucose >33.3 mmol/L and elevated osmolality).
- Known allergy to corticosteroids.
- Patients requiring anti-inflammatory corticosteroids or replacement hydrocortisone for any reason, or those already receiving prednisone >15 mg/day (or equivalent dose of another corticosteroid).
- Pregnant or breastfeeding women.
About this study
Official title: An Embedded Adaptive Randomized Controlled Trial of Corticosteroid Therapy for Severe Influenza Community-Acquired Pneumonia in Adults
Severe community-acquired pneumonia caused by influenza virus (hereafter referred to as severe influenza pneumonia) is a major etiology of community-acquired pneumonia leading to acute respiratory failure and ICU admission. It can rapidly progress to profound hypoxemia, acute respiratory distress syndrome (ARDS), and multiple organ dysfunction, and remains associated with substantial mortality. Although antiviral therapy-typically neuraminidase inhibitors-and well-established organ-support strategies are currently available, outcomes in a subset of critically ill patients remain poor despite antiviral and supportive care alone, with ICU mortality reported to be as high as 20-30%. Therefore, identifying effective adjunctive interventions beyond standard care to further reduce mortality in severe influenza pneumonia is of great clinical importance for improving outcomes in critically ill patients and alleviating the burden on families and society.
However, the use of systemic corticosteroids in influenza-associated community-acquired pneumonia (CAP) has long been highly controversial. Multiple studies have suggested that corticosteroid therapy may increase mortality among patients with H1N1 influenza. During the early phase of the COVID-19 pandemic, treatment strategies drew on this evidence and generally advised caution regarding corticosteroid use; subsequently, randomized controlled trials (RCTs) such as RECOVERY and REMAP-CAP demonstrated that low-dose corticosteroids (e.g., dexamethasone 6 mg/day) reduce mortality in patients with pneumonia requiring oxygen therapy. Recently, the U.S. Centers for Disease Control and Prevention (CDC) has emphasized the urgent need for RCTs evaluating low- to moderate-dose corticosteroids or other immunomodulatory agents to clarify their role in the management of influenza-associated CAP. Collectively, these observations underscore the urgency of pathogen-directed anti-inflammatory strategies for CAP-associated acute respiratory failure.
Accordingly, we plan to conduct an adaptive, randomized, open-label, controlled trial to evaluate the efficacy and safety of adjunctive corticosteroid regimens at different doses, in addition to early standard supportive care (including guideline-concordant antiviral therapy and organ support), for reducing mortality in patients with severe influenza pneumonia.
- Conditions
- Influenza
- Being tested
- Saline (0.9%, sterile, for infusion), low dose Methylprednisolone, Moderate dose Methylprednisolone
- Keywords
- Influenza, community-acquired pneumonia, adaptive randomised controled trial, corticosteroids
- Medical subject headings
- Influenza, Human, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline (0.9%, sterile, for infusion)Drug
Sailine as control
low dose MethylprednisoloneDrug
Methylprednisolone 0.5mg/kg ivgtt qd
Moderate dose MethylprednisoloneDrug
Methylprednisolone 1.0mg/kg ivgtt qd
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Placebo comparator | Control group Receives: Drug: Saline (0.9%, sterile, for infusion) |
| Low dose steroids | Experimental | treated with low dose corticosteroids Receives: Drug: low dose Methylprednisolone |
| Moderate dose steroids | Experimental | treated with moderate dose corticosteroids Receives: Drug: Moderate dose Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all cause mortality
Measured: 28 days from inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 496 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingyuan Zhan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qingyuan Zhan, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351500
- Sponsor's protocol ID
- 2025-I2M-C&T-B-090C
- Acronym
- CAPSTONE-IFV
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Embedded Adaptive Randomized Controlled Trial of Corticosteroid Therapy for Severe Influenza Community-Acquired Pneumonia in Adults
- ClinicalTrials.gov ID
- NCT07351500
- Acronym / sponsor ID
- CAPSTONE-IFV / 2025-I2M-C&T-B-090C
- Conditions
- Influenza
- Keywords
- Influenza, community-acquired pneumonia, adaptive randomised controled trial, corticosteroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 496 participants (estimated)
- Lead sponsor
- Qingyuan ZhanUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Severe community-acquired pneumonia caused by influenza virus (hereafter referred to as severe influenza pneumonia) is a major etiology of community-acquired pneumonia leading to acute respiratory failure and ICU admission. It can rapidly progress to profound hypoxemia, acute respiratory distress syndrome (ARDS), and multiple organ dysfunction, and remains associated with substantial mortality. Although antiviral therapy-typically neuraminidase inhibitors-and well-established organ-support strategies are currently available, outcomes in a subset of critically ill patients remain poor despite antiviral and supportive care alone, with ICU mortality reported to be as high as 20-30%. Therefore, identifying effective adjunctive interventions beyond standard care to further reduce mortality in severe influenza pneumonia is of great clinical importance for improving outcomes in critically ill patients and alleviating the burden on families and society.
However, the use of systemic corticosteroids in influenza-associated community-acquired pneumonia (CAP) has long been highly controversial. Multiple studies have suggested that corticosteroid therapy may increase mortality among patients with H1N1 influenza. During the early phase of the COVID-19 pandemic, treatment strategies drew on this evidence and generally advised caution regarding corticosteroid use; subsequently, randomized controlled trials (RCTs) such as RECOVERY and REMAP-CAP demonstrated that low-dose corticosteroids (e.g., dexamethasone 6 mg/day) reduce mortality in patients with pneumonia requiring oxygen therapy. Recently, the U.S. Centers for Disease Control and Prevention (CDC) has emphasized the urgent need for RCTs evaluating low- to moderate-dose corticosteroids or other immunomodulatory agents to clarify their role in the management of influenza-associated CAP. Collectively, these observations underscore the urgency of pathogen-directed anti-inflammatory strategies for CAP-associated acute respiratory failure.
Accordingly, we plan to conduct an adaptive, randomized, open-label, controlled trial to evaluate the efficacy and safety of adjunctive corticosteroid regimens at different doses, in addition to early standard supportive care (including guideline-concordant antiviral therapy and organ support), for reducing mortality in patients with severe influenza pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Placebo comparator | Drug: Saline (0.9%, sterile, for infusion)Control group |
| Low dose steroids | Experimental | Drug: low dose Methylprednisolonetreated with low dose corticosteroids |
| Moderate dose steroids | Experimental | Drug: Moderate dose Methylprednisolonetreated with moderate dose corticosteroids |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age ≥ 18 years.
- Admission to the Intensive Care Unit (ICU).
- Meeting the diagnostic criteria for community-acquired pneumonia (CAP).
- Meeting at least one of the major diagnostic criteria for severe pneumonia:
- Septic shock requiring vasopressor therapy after adequate fluid resuscitation.
Key exclusion criteria (12 listed)
- Patients receiving vasopressor therapy for septic shock at the time of enrollment.
- Terminally ill patients (expected survival <30 days, e.g., advanced malignancy).
- Clinical history suggesting overt aspiration.
- Documented active gastrointestinal bleeding.
- Presence of cystic fibrosis, obstructive pneumonia, active influenza, pulmonary tuberculosis, or fungal infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline (0.9%, sterile, for infusion)Sailine as control | Drug | Standard of Care |
| low dose MethylprednisoloneMethylprednisolone 0.5mg/kg ivgtt qd | Drug | Low dose steroids |
| Moderate dose MethylprednisoloneMethylprednisolone 1.0mg/kg ivgtt qd | Drug | Moderate dose steroids |
Primary outcome
28-day all cause mortality
Time frame: 28 days from inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Saline (0.9%, sterile, for infusion), low dose Methylprednisolone and Moderate dose Methylprednisolone in people with Influenza, run by Qingyuan Zhan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day all cause mortality (time frame: 28 days from inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.