Daily Mosnodenvir as Dengue Prophylaxis in a Controlled Human Infection Model.
Durbin AP, Van Wesenbeeck L, Pierce KK, Herrera-Taracena G, Ebone L, Buelens A, Lutton P, Sabundayo BP, Van Eygen V, De Clerck K, Fetter I, Voge NV, Fang X, Goeyvaerts N, Vandendijck Y, Mayfield J, Lenz O, De Meyer S, Kakuda TN, He H, Amaro-Carambot E, Akli RD, Carmolli M, De Marez T, Whitehead SS, Van Loock M, Rasschaert F
Paper source
Daily Mosnodenvir as Dengue Prophylaxis in a Controlled Human Infection Model.
This rigor review was examined and confirmed by Adcurare Editorial · July 6, 2026
How this rating was calculated▸
- ReportingData & code availability not met−0.5★
- ReportingEthical approvals partially met−0.25★
- ReportingStatistical analysis partially met−0.25★
- No reported statistical tests were found to recompute.
- Data and code not shared
- Statistical reporting gaps (tests, assumptions, effect sizes)
- Ethics/consent reporting incomplete
This Adcurare Rigor Review uses AI Rigor Reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.
This phase 2a CHIM trial is methodologically well-designed (randomized, double-blind, placebo-controlled) with a clear scientific premise. However, it has critical reporting gaps: no data availability statement, no effect sizes or confidence intervals for the primary analysis, and the ethics committee is not named. Several minor copyedit issues (e.g., a malformed percentage in Table 1) should also be corrected before submission.
Three independent reviewer reports were synthesized (each scored all eight dimensions). The reviewers diverged on ethical approvals (pass vs. warn), statistical analysis (pass vs. warn), and data code availability (warn vs. fail). The synthesis adopted the more conservative (stricter) rating in each case based on the pre-defined scoring criteria. Statistics verification examined 0 tests (coverage note: threshold-only p-values cannot be machine-verified), so no claim of mathematical correctness is made. The citation check found no retracted or unresolvable references.
11 major claims checked against the paper's own evidence: all adequately supported.
8 copyedit issues flagged: mostly consistency, clarity, punctuation.
Checked 33 references: 2 verified — 31 not checked.
2 data/code links checked; 2 live.
Registered (2 IDs: ClinicalTrials.gov). No reporting guideline cited.
The paper is not ready to submit as-is. It requires a data availability statement (critical), addition of effect sizes with CIs for the primary analysis (high), and naming of the ethics committee (high). Several minor copyedit fixes (especially the malformed '8.79.1' value in Table 1) should also be addressed. After these revisions, the paper will be submission-ready.
- 1.HIGHdata codeAdd a data availability statement in a dedicated section before the references describing how qualified researchers can access individual participant data (e.g., via a managed-access repository or upon reasonable request to the corresponding author with a data-sharing agreement).ClinicalTrials.gov requires a data-sharing plan, and the absence of any data availability statement is a common ground for editorial return before review.
- 2.HIGHstatisticsReport the effect size (e.g., mean difference in log10 AUC D1-D29 VL) with its 95% confidence interval from the Tobit model for the high-dose versus placebo comparison in the Results (Primary endpoint analysis).P-values alone do not convey the magnitude or precision of the treatment effect; effect sizes and CIs are expected for primary analyses in phase 2 trials.
- 3.HIGHethicsName the specific institutional review board (IRB) or ethics committee that approved the study at each site, and if available include the protocol approval number, in the Methods (Study oversight) section.A generic statement ('Independent Ethics Committees at each site') is insufficient for verification and is a standard requirement for journal submission.
- 4.HIGHstatisticsProvide exact p-values (e.g., 'p = 0.0003') instead of thresholds ('p < 0.001') for the Tobit and Wilcoxon test results in the Results (Primary endpoint analysis).Exact p-values allow readers to assess the evidence more precisely and are required by many journals.
- 5.MEDIUMstatisticsAdd a statement verifying or justifying the assumptions of the Tobit model (e.g., normality of residuals, homoscedasticity, absence of influential points) in the Methods (Statistical analysis) section.Model-based analyses require assumption verification to ensure validity; this is a standard reviewer request.
- 6.MEDIUMotherProvide the source (e.g., company, catalog number, or RRID) for the challenge virus strain rDEN3Δ30 in the Methods (Study procedures) section.Naming the strain without a source prevents other researchers from identifying or procuring the exact material used.
- 7.MEDIUMreportingAdd a statement that the study is reported in accordance with the CONSORT statement and, if required by the journal, attach a completed CONSORT checklist in the Methods (Study oversight) section.Reference to a reporting guideline is now standard for RCTs and CHIM trials and is often required by journals.
- 8.MEDIUMotherDescribe the randomization method (e.g., computer-generated random numbers, block randomization with block sizes) in the Methods (Study oversight) section.Simply stating 'randomized' without the method of sequence generation is insufficient for reproducibility and risk of bias assessment.
- 9.MEDIUMotherReport body weight or body mass index (BMI) in Table 1 or the Methods (Participants) section.Weight/BMI is a standard baseline characteristic for clinical trials, especially when drug dosing is weight-based or when general health status is described.
- 10.LOWcopyeditCorrect the malformed percentage '8.79.1' in Table 1 (Multiple race category for the Combined group) to the correct value (likely 2/22 = 9.1%).This value appears to be a formatting artifact and should be corrected before submission to avoid confusion.
- 11.LOWcopyeditStandardize the formatting of 'log10' (remove the space before 10) and consistently use parentheses around 'VL' throughout the Abstract and Methods (e.g., 'log10 AUC D1-D29 (VL)').Consistent formatting improves readability and professionalism.
- 12.LOWcopyeditCombine 'Skin And Subcutaneous Tissue | Disorders' into 'Skin and subcutaneous tissue disorders' in Table 2 for consistency with other system organ class headings.Inconsistent table formatting can distract reviewers and suggest lack of attention to detail.
Adcurare assesses methodological rigor, not the importance of the findings. See how we evaluate →