Evidence map›Paper›PMID 40852135›Full record

Trial reportOpen forum infectious diseases2025

Effects of Baloxavir Marboxil Plus Neuraminidase Inhibitor vs Neuraminidase Inhibitor in High-risk Patients Hospitalized With Severe Influenza: A Post Hoc Analysis of the Flagstone Trial.

Mengwei Yan, Xiaoying Gu, Yeming Wang, Bin Cao

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in Open forum infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03684044 (A Phase III, Randomized, Double-Blind Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety of Baloxavir Marboxil in Combination With Standard-of-Care Neuraminidase Inhibitor in Hospitalized Participants With Severe Influenza), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03684044 phase3completednot on this map

A Phase III, Randomized, Double-Blind Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety of Baloxavir Marboxil in Combination With Standard-of-Care Neuraminidase Inhibitor in Hospitalized Participants With Severe Influenza

TypeinterventionalSponsorHoffmann-La RocheRan2019 to 2020Enrolled363ConditionsInfluenzaArmsBaloxavir Marboxil, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Influenza.Nature reviews. Disease primers · 2026
    Review
  3. Article
  4. Review
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Mengwei YanDepartment of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Capital Medical University, Beijing, P.R.  China.
Xiaoying GuNational Center for Respiratory Medicine ; State Key Laboratory of Respiratory Health and Multimorbidity; National Clinical Research Center for Respiratory Diseases; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences; Beijing Key Laboratory of Surveillance, Early Warning and Pathogen Research on Emerging Infectious Diseases; Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, P.R.  China.
Yeming WangDepartment of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Capital Medical University, Beijing, P.R.  China.
Bin CaoDepartment of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Capital Medical University, Beijing, P.R.  China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Combining baloxavir with neuraminidase inhibitors (NAIs) has not demonstrated significant benefits in severe influenza. High-risk populations with impaired viral clearance may represent the optimal candidates for this combination treatment. Methods: We conducted a post hoc analysis of the Flagstone trial (NCT03684044), including patients hospitalized with severe influenza. Eligible participants met at least 1 of the following criteria: immunosuppression, diabetes, or chronic lung disease. Time to clinical improvement (TTCI), 28-day mortality, virological outcomes, and safety end points were assessed. Results: Among the 143 patients included in the efficacy analysis, 92 received baloxavir in combination with NAI (dual antiviral group), while 51 received NAIs alone (mono antiviral group). The median TTCI did not differ significantly between groups ( Conclusions: The combination of baloxavir and NAI demonstrated superior mortality reduction compared with NAI monotherapy, without increasing the risk of adverse events.

Indexed as

baloxavirdual antiviral therapyhigh-riskpost hoc analysissevere influenza

Identifiers

PMID40852135
PMCPMC12368417

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.