Adaptive RCT of Corticosteroids for Severe Influenza Pneumonia in Adults

Sponsor
Qingyuan Zhan
Study ID
NCT07351500
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Influenza

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Saline (0.9%, sterile, for infusion) — DRUG
    Sailine as control
  • low dose Methylprednisolone — DRUG
    Methylprednisolone 0.5mg/kg ivgtt qd
  • Moderate dose Methylprednisolone — DRUG
    Methylprednisolone 1.0mg/kg ivgtt qd

Study Details

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.

Key Dates

First listed
Jan 20, 2026
Start date
Jan 15, 2026
Status verified
Jan 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
496 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Standard of Care
    Control group
  • Experimental: Low dose steroids
    treated with low dose corticosteroids
  • Experimental: Moderate dose steroids
    treated with moderate dose corticosteroids

Primary Outcome Measure

28-day all cause mortality [ Time Frame: 28 days from inclusion ]

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