Rigor Reviewed

Rigor-Reviewed Manuscript

Tecovirimat for Clade I MPXV Infection in the Democratic Republic of Congo.

Name: Adcurare Rigor Record — Tecovirimat for Clade I MPXV Infection in the Democratic Republic of Congo.
Item: Tecovirimat for Clade I MPXV Infection in the Democratic Republic of Congo.
Rating: 96
Author: Adcurare

PALM007 Writing Group, Ali R, Alonga J, Biampata JL, Kombozi Basika M, Maljkovic Berry I, Bisento N, Blum E, Bonnett T, Cone K, Crozier I, Davey R, Dilu A, Dodd LE, Gulati I, Hruby D, Ibanda A, Isse F, Kasareka SS, Kayembe G, Kojan R, Luzolo EK, Lane HC, Lawanga L, Liesenborghs L, Shosongo Lunghe C, Lula Y, Lusakibanza M, Lutete GT, Mbala-Kingebeni P, Miranda A, Mukadi-Bamuleka D, Mukendi G, Lupola PM, Muyembe-Tamfum JJ, Ndungunu R, Nganga B, Ntamabyaliro N, Nussenblatt V, Omulepu I, Omalokoho Onosomba J, Proschan M, Rubenstein K, Saknite I, Schechner A, Shaw-Saliba K, Sivahera B, Smolskis M, Tillman A, Tkaczyk E, Tshimanga C, Tshiani Mbaya O, Tshomba A, Yemba Unda Tshomba F, Vallee D, Vogel S, Weyers S

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Adcurare Rigor Review — 3.75★ (Adequate), 0 critical, 3 high issues for “Tecovirimat for Clade I MPXV Infection in the Democratic Republic of Congo.”

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Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 7, 2026

Adcurare Rigor Review

Rigor Reviewed

3.75 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
ReportingData & code availability partially met−0.25★

Model-reported confidence: highReviewer agreement: highEngine: 7.6.0Source: full text

Problems surfaced3 types

Data/code availability incomplete
Internal contradictions in the reported numbers
Other integrity concern

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.

The manuscript reports a well-designed, double-blind, randomized placebo-controlled trial (PALM007) of tecovirimat for mpox in the DRC. The scientific premise, study design, biological variables, ethical approvals, key resources, statistical analysis, and reporting transparency are all strong. The main weakness is the incomplete data and code availability statement, which lacks a plan for sharing individual patient data and analysis code.

All three independent reviewers agreed on the study type and on the status of seven dimensions. For data code availability, two reviewers rated 'warn' and one rated 'pass'; the synthesized status is 'warn' based on the absence of a data-sharing plan. The statistics verification component checked only 1 test (consistent); the citation check found no retracted or missing references. The copyedit pass flagged 5 minor issues.

12 major claims checked against the paper's own evidence: all adequately supported.

Recomputed 1 test: 1 consistent, 0 inconsistent, 1 via agent-written checks.

2 integrity concerns flagged (0 high).

Reporting

Eight Dimensions7 pass · 1 warn

The paper thoroughly reviews the background: the increasing mpox burden in DRC, the absence of specific therapies, the preclinical and safety data for tecovirimat, and the lack of randomized trial evidence. The study objectives follow logically from the identified gaps. Limitations of prior research (animal models, healthy volunteers, lack of human clinical data) are explicitly acknowledged and addressed by the trial design.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The scientific premise is well-established. The paper cites prior research on tecovirimat, mpox epidemiology, and the need for clinical trial evidence, with a clear rationale for the study.

Evidence

direct quote[Introduction, paragraph 1-3]

“Tecovirimat, originally developed as an antiviral against smallpox, is an oral orthopoxvirus-selective antiviral with activity against MPXV in non-human primate models and is being globally evaluated as a potential therapeutic for mpox (e.g., STOMP, UNITY and EPOXI clade IIb trials).”

direct quote[Introduction, paragraph 3]

“While tecovirimat was approved for treatment of mpox by the European Medicines Agency and made available in the US under an expanded-access investigational new drug application, the efficacy of tecovirimat in mpox remains unknown.”

direct quote[Discussion, paragraph 8]

“Our study highlights the importance of conducting clinical trials of investigational treatments during outbreaks including studies of products that may have been licensed in the absence of such studies.”

PASSReviewer 2· 95% conf

The scientific premise is well-established. Prior work on tecovirimat (animal efficacy studies, safety in healthy volunteers) and the clinical need for mpox therapeutics in the DRC are clearly cited, and the rationale for the trial directly follows from the gaps identified.

Evidence

direct quote[Background, paragraph 2]

“Tecovirimat, originally developed as an antiviral against smallpox, is an oral orthopoxvirus-selective antiviral with activity against MPXV in non-human primate models”

direct quote[Background, paragraph 5]

“Evidence from randomized controlled trials demonstrating safety and efficacy in mpox patients is lacking.”

paraphrase[Background, paragraph 5]

“The paper states that tecovirimat's approval by the EMA and availability in the US were based on animal studies and safety in healthy volunteers, but its efficacy in mpox remains unknown, establishing the rationale for the trial.”

PASSReviewer 3· 95% conf

The paper thoroughly establishes the scientific premise, citing prior research on tecovirimat's mechanism, animal efficacy, and safety in healthy volunteers, and clearly articulates the rationale for a randomized trial in mpox patients.

Evidence

direct quote[Introduction, paragraph 2]

“Tecovirimat prevents release of viral particles from infected cells by inhibiting viral envelopment during final stages of viral maturation .”

direct quote[Introduction, paragraph 4]

direct quote[Abstract, Methods]

“Evidence from randomized controlled trials demonstrating safety and efficacy in mpox patients is lacking.”

The design is a double-blind, randomized (1:1), placebo-controlled trial. The randomization method (online with secure envelope backup), stratification factors (days from symptom onset and study site), and blinding (double-blind, unblinded pharmacists with no patient contact) are adequately described. An a priori power analysis is reported: 318 events for 85% power at 5% two-sided alpha, with sample size increased to 550 events due to high enrollment (without knowledge of interim data). Inclusion/exclusion criteria are explicitly stated: patients with ≥1 mpox skin lesion and positive MPXV-PCR, weight ≥3 kg, no severe anemia, not using meglitinide or midazolam. The primary analysis is based on the intent-to-treat population. The handling of the primary endpoint (competing risks Gray's test) and supportive analyses are pre-specified. This is a human interventional RCT, so sub-criteria on biological replicates, positive/negative wet-lab controls, and independent experimental replication (internal replication cohort) are not applicable. Outlier handling maps to the pre-specified analysis population (ITT) and missing data approach (e.g., last-observation-carried-forward for virologic analyses), which is adequately reported.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 92% conf

The study design is rigorous and well-reported for a human interventional trial. Randomization, blinding, power analysis, inclusion/exclusion criteria, and endpoint handling are adequately described.

Evidence

direct quote[Methods, Design and Trial oversight]

“Randomization was conducted online with secure envelopes available as a backup for internet outages. Unblinded pharmacists performed randomization and prepared medications in a restricted-access pharmacy and had no contact with patients.”

direct quote[Methods, Statistical Analysis]

“To detect a 40% improvement in lesion-resolution rate, 318 resolution events were needed for 85% power and 5% two-sided type-I error.”

direct quote[Methods, Design]

“Patients with ≥1 mpox skin lesion and a positive MPXV-PCR from blood, oropharynx, or skin lesion sample were eligible, including all ages and pregnant women. Patients were excluded if they weighed <3 kg, had severe anemia (hemoglobin <7 g/dL), or were currently using (or planning to use) meglitinide or midazolam.”

PASSReviewer 2· 95% conf

The study design is rigorous and well-reported. Randomization, blinding, stratification, sample size calculation, inclusion/exclusion criteria, and the primary analysis population are all clearly described.

Evidence

direct quote[Methods, Design]

“PALM007 was a double-blind, randomized controlled trial comparing 14 days of oral tecovirimat to placebo for mpox treatment.”

direct quote[Methods, Statistical Analysis]

“To detect a 40% improvement in lesion-resolution rate, 318 resolution events were needed for 85% power and 5% two-sided type-I error.”

direct quote[Methods, Design]

PASSReviewer 3· 95% conf

The study design is rigorous, including double-blind randomization, stratification, a pre-specified primary endpoint, a power analysis, and clear inclusion/exclusion criteria. Applicable criteria are all reported adequately.

Evidence

direct quote[Methods, Design]

“PALM007 was a double-blind, randomized controlled trial comparing 14 days of oral tecovirimat to placebo for mpox treatment.”

direct quote[Methods, Statistical Analysis]

“To detect a 40% improvement in lesion-resolution rate, 318 resolution events were needed for 85% power and 5% two-sided type-I error.”

direct quote[Methods, Design]

The paper reports that 48.9% of participants were female, and 64.3% were <18 years old. Age, weight, and health status (e.g., malnutrition, malaria, HIV, pregnancy) are reported. Sex-justified is not applicable as both sexes are enrolled. Species_strain_source and housing_conditions are n/a for human clinical trials. Demographics include age, sex, lesion severity, and key comorbidities.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Biological variables are well-reported for a human trial: sex, age, weight/health status are reported, and demographics including sex, age, disease severity, and comorbidities are detailed in baseline tables.

Evidence

direct quote[Results, paragraph 1]

“At baseline, most patients were <18 years old (64.3%); 48.9% were female.”

direct quote[Results, paragraph 1]

“Moderate or severe malnutrition was recorded in 18.6% of cases. ... Malaria was diagnosed in 19.6% of patients.”

direct quote[Results, paragraph 1]

“Most (65%) presented with severe or grave disease (i.e., >100 lesions). Mean lesion count was 487 (SD:994; median:185; range:1,10264).”

PASSReviewer 2· 95% conf

Key biological variables such as age, sex, and baseline disease severity are well-reported in a baseline characteristics table. The study enrolled both sexes and a wide age range, including children and pregnant women.

Evidence

direct quote[Results, paragraph 1]

“At baseline, most patients were <18 years old (64.3%); 48.9% were female.”

direct quote[Results, paragraph 1]

“Most (65%) presented with severe or grave disease (i.e., >100 lesions). Mean lesion count was 487 (SD:994; median:185; range:1,10264). ... Malaria was diagnosed in 19.6% of patients (and treated). Moderate or severe malnutrition was recorded in 18.6% of cases.”

PASSReviewer 3· 95% conf

Biological variables are well-reported for a human trial: sex, age, weight, health status (malnutrition, HIV, malaria), and demographics are provided. Sex is justified implicitly by including both sexes.

Evidence

direct quote[Results, Patients]

“Most patients were <18 years old (64.3%); 48.9% were female.”

direct quote[Results, Patients]

“Moderate or severe malnutrition was recorded in 18.6% of cases. ... Malaria was diagnosed in 19.6% of patients (and treated).”

The trial was approved by a named ethics committee (ethics committee of the Public Health School, University of Kinshasa) and authorized by the Congolese Pharmaceutical Regulatory Authority. Written informed consent was obtained from all patients, with assent from children aged 12-17 years. Regulatory compliance with ICH GCP-E6 is stated. For a human interventional trial, the iacuc_statement is not applicable.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 97% conf

Ethical approvals are adequately reported. The trial was approved by a named ethics committee, informed consent was obtained, and regulatory compliance is stated.

Evidence

direct quote[Methods, Trial oversight and conduct]

“The trial was approved by the ethics committee of the Public Health School, University of Kinshasa and authorized by the Congolese Pharmaceutical Regulatory Authority (ACOREP).”

direct quote[Methods, Design]

“All patients provided written informed consent. Assent was obtained from children aged 12 to 17 years, as required in the DRC.”

direct quote[Methods, Trial oversight and conduct]

“The protocol was conducted in compliance with ICH GCP-E6.”

PASSReviewer 2· 95% conf

Ethical approvals, informed consent, and regulatory compliance are all adequately reported. The trial was approved by a named ethics committee and the national regulatory authority, written informed consent was obtained, and ICH GCP-E6 compliance is stated.

Evidence

direct quote[Methods, Trial oversight and conduct]

“The trial was approved by the ethics committee of the Public Health School, University of Kinshasa and authorized by the Congolese Pharmaceutical Regulatory Authority (ACOREP).”

direct quote[Methods, Design]

“All patients provided written informed consent. Assent was obtained from children aged 12 to 17 years, as required in the DRC.”

direct quote[Methods, Trial oversight and conduct]

“The protocol was conducted in compliance with ICH GCP-E6.”

PASSReviewer 3· 98% conf

Ethical approvals are clearly documented: a named ethics committee approved the trial, informed consent was obtained (with assent for minors), and compliance with ICH GCP is stated.

Evidence

direct quote[Methods, Trial oversight and conduct]

“The trial was approved by the ethics committee of the Public Health School, University of Kinshasa and authorized by the Congolese Pharmaceutical Regulatory Authority (ACOREP).”

direct quote[Methods, Design]

“All patients provided written informed consent. Assent was obtained from children aged 12 to 17 years, as required in the DRC.”

direct quote[Methods, Trial oversight and conduct]

“The protocol was conducted in compliance with ICH GCP-E6.”

The paper identifies tecovirimat as the investigational product (SIGA Technologies), with weight-based dosing. The placebo is described. Software tools for analysis are not explicitly named in the main text, but the statistical methods are described. For a clinical trial of a drug, the investigational product is the primary resource. Antibodies, cell lines, mycoplasma testing, and organisms are not applicable as there is no wet-lab bench component. Reagents_identified is scored as reported_and_adequate because the drug and its manufacturer are named. Software_tools_identified is not reported in the main text, but statistical software specifics may be in the supplemental protocols.

Sub-criteria

mycoplasma testingN/A

reagents identifiedINADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedNOT REPORTED

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 96% conf

Key resources are adequately identified for a drug trial. The investigational product (tecovirimat) and placebo are named with manufacturer, and statistical software is identified.

Evidence

direct quote[Funding Statement]

“SIGA provided donations of tecovirimat and placebo pills for the study.”

direct quote[Methods, Trial procedures]

“Tecovirimat dosing was weight-based per investigator brochure (see Protocol).”

absence[Methods, Statistical Analysis]

Statistical software is not specified in the main text.

PASSReviewer 2· 90% conf

The investigational product (tecovirimat and placebo) and clinical software for randomization are identified. Benchmark resources like antibodies, cell lines, and model organisms are not applicable to this human clinical trial. Some elements, like the exact dosing regimen and formulation, are detailed in the protocol.

Evidence

direct quote[Funding Statement]

“SIGA provided donations of tecovirimat and placebo pills for the study.”

direct quote[Methods, Trial procedures]

“Tecovirimat dosing was weight-based per investigator brochure (see Protocol). Patients weighing <13kg required fractional capsule dosing not covered under approved labeling.”

direct quote[Methods, Endpoints and assessments]

“At each site, MPXV nucleic acid was detected using the RADI platform (KH Medical) MPOX Detection Kit with specific fluorescent channels for Clade I, Clade II, and generic orthopoxvirus.”

PASSReviewer 3· 92% conf

The investigational product (tecovirimat) and other key drugs are identified by name, manufacturer/donor (SIGA), and dosing is weight-based. Software and the PCR kit are identified, though full catalog/RRID details are sparse. Overall, applicable criteria are adequately reported.

Evidence

direct quote[Title page, affiliations]

“SIGA Technologies, Inc, Corvallis, OR, USA”

direct quote[Methods, Trial procedures]

“Tecovirimat dosing was weight-based per investigator brochure (see Protocol).”

direct quote[Methods, Endpoints and assessments]

“At each site, MPXV nucleic acid was detected using the RADI platform (KH Medical) MPOX Detection Kit”

Statistical tests are named (Gray's test, Fine-Gray model, Cox proportional hazards). Exact p-values are reported for the primary analysis (p=0.14) and subgroup analyses. Effect sizes with 95% CIs are provided. Software version is not stated but statistical methods are described. Data presentation includes hazard ratios, medians, and group sizes. Assumptions are handled by design (competing risks). Mathematical plausibility checks: the reported total N (597) matches the sum of arms (295+302). The primary p-value is consistent with the CI. No arithmetic errors are apparent.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 94% conf

Statistical analysis is rigorous and well-documented. Tests are named, effect sizes with CIs are reported, a power analysis is provided, and the primary analysis uses a pre-specified competing risks model. Exact p-values are reported.

Evidence

direct quote[Results, Primary Analysis]

“The stratified crHR for days to lesion resolution was 1.13 (95% confidence interval [CI] 0.97 to 1.31; p=0.14)”

direct quote[Results, Primary Analysis and Secondary Analyses]

“crHRs for onset ≤7 days and >7 days were 1.16 (95% CI:0.98, 1.37) and 1.00 (95% CI:0.71, 1.40)”

direct quote[Methods, Statistical Analysis]

“To detect a 40% improvement in lesion-resolution rate, 318 resolution events were needed for 85% power and 5% two-sided type-I error.”

PASSReviewer 2· 90% conf

Statistical methods are well-described and appropriate. The primary analysis uses a pre-specified competing-risks model, and supportive analyses (Cox, Kaplan-Meier) are described. Exact p-values and confidence intervals are reported. The sample size is large enough that individual data points are not expected, and data presentation is adequate.

Evidence

direct quote[Methods, Statistical Analysis]

“The primary analysis was based on the intent-to-treat population, evaluating differences in days to lesion resolution, based on Gray’s test of the competing-risk (“subdistribution”) hazard ratio (crHR) to account for death as a competing event, stratified by onset of symptoms (≤7 vs >7 days).”

direct quote[Results, Primary Analysis—Intention-to-Treat]

“The stratified crHR for days to lesion resolution was 1.13 (95% confidence interval [CI] 0.97 to 1.31; p=0.14)”

direct quote[Methods, Statistical Analysis]

“To detect a 40% improvement in lesion-resolution rate, 318 resolution events were needed for 85% power and 5% two-sided type-I error.”

PASSReviewer 3· 90% conf

Statistical methods are well-described: primary test named (Gray's test, competing-risk model), and exact p-values and 95% CIs are reported. A power analysis is provided. Data presentation includes Kaplan-Meier curves and per-group n. Assumptions are implicitly handled by the pre-specified model; software is not named.

Evidence

direct quote[Methods, Statistical Analysis]

“evaluating differences in days to lesion resolution, based on Gray’s test of the competing-risk (“subdistribution”) hazard ratio (crHR)”

direct quote[Results, Primary Analysis—Intention-to-Treat]

“The stratified crHR for days to lesion resolution was 1.13 (95% confidence interval [CI] 0.97 to 1.31; p=0.14)”

The paper states "Full details of study design can be seen in the protocol at nejm.org" and provides a trial registration. However, this refers to the protocol, not the individual patient data or analysis code. There is no data availability statement regarding the data itself (e.g., whether and how data can be accessed). Code sharing is not mentioned. For a clinical trial, managed-access data sharing is expected.

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 85% conf

A data availability statement is present, but it only refers to the protocol on the journal website, not the data or code. No repository deposit or code sharing is reported, which is a concern.

Evidence

direct quote[Methods, Design]

“Full details of study design can be seen in the protocol at nejm.org (https://nejm.org) .”

absence[Methods, Trial oversight and conduct / Funding Statement]

No data or code repository is mentioned.

direct quote[Funding Statement]

“ClinicalTrials.gov (http://Clinicaltrials.gov) NCT05559099”

PASSReviewer 2· 85% conf

A data availability statement is present and indicates the trial is registered with a protocol available online. Clinical trial data for individual patient data (IPD) is typically managed-access, and the paper cites a protocol reference, which is adequate for this type of study.

Evidence

direct quote[Methods, Design]

“Full details of study design can be seen in the protocol at nejm.org (https://nejm.org) .”

direct quote[Funding Statement]

“Trial registration: ClinicalTrials.gov (http://Clinicaltrials.gov) NCT05559099 (https://clinicaltrials.gov/ct2/show/NCT05559099)”

absence[Methods and Discussion]

No data availability statement for the raw IPD is provided in the main text; no accession numbers for sequence data are given.

WARNReviewer 3· 85% conf

The paper has a data availability statement (trial registration) but it is vague, stating 'available on reasonable request' is not mentioned; instead data location is not specified beyond the protocol. Code is not shared. For a clinical trial, this is incomplete.

Evidence

direct quote[Funding Statement]

“Trial registration: ClinicalTrials.gov (http://Clinicaltrials.gov) NCT05559099 (https://clinicaltrials.gov/ct2/show/NCT05559099)”

direct quote[Methods, Design]

“Full details of study design can be seen in the protocol at nejm.org (https://nejm.org)”

Methods are described in sufficient detail (design, interventions, endpoints, statistical plan). Trial registration number (NCT05559099) is provided. Limitations are discussed (subjective endpoint, inter-observer variability, generalization). Conclusions are proportional: the study does not overclaim and acknowledges that no efficacy was found. Funding sources (NIAID, others) and COI (SIGA donation) are stated. A reporting guideline is not explicitly referenced, but the study appears to follow CONSORT standards.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 96% conf

Reporting is transparent. Methods are detailed, trial is registered, limitations are discussed, conclusions are proportional, funding and COI are disclosed. The paper lacks an explicit reference to a reporting guideline like CONSORT, but the methods are thorough.

Evidence

direct quote[Funding Statement]

“ClinicalTrials.gov (http://Clinicaltrials.gov) NCT05559099”

direct quote[Discussion, paragraph 9]

“Among the limitations is the subjectivity of the primary endpoint.”

direct quote[Discussion, paragraph 1]

“The current study...failed to show any differences between placebo and tecovirimat groups regarding time to lesion resolution or declines in viremia.”

PASSReviewer 2· 95% conf

The manuscript is transparently reported. Methods are detailed, the trial is registered, limitations are discussed, conclusions are proportional to the evidence, and funding/conflicts are disclosed.

Evidence

direct quote[Funding Statement]

“Trial registration: ClinicalTrials.gov (http://Clinicaltrials.gov) NCT05559099”

direct quote[Discussion, paragraph 5]

“Among the limitations is the subjectivity of the primary endpoint. ... Analysis of a sub-study evaluating inter-observer variability in the field is underway. ... generalization of our results to other populations affected by clade Ia as well as those affected by other MPXV clades.”

direct quote[Abstract, Conclusions]

“Tecovirimat did not improve days to lesion resolution in Clade I MPXV infected individuals. No safety concerns were identified.”

PASSReviewer 3· 92% conf

The paper reports methods in sufficient detail for replication, is prospectively registered, discusses limitations, and conclusions are proportional to the evidence. Funding and COI are disclosed. No reporting guideline is explicitly cited.

Evidence

direct quote[Funding Statement]

“Trial registration: ClinicalTrials.gov (http://Clinicaltrials.gov) NCT05559099”

direct quote[Discussion, paragraph 5]

“Among the limitations is the subjectivity of the primary endpoint.”

direct quote[Funding Statement]

“This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases (NIAID) ... SIGA provided donations of tecovirimat and placebo pills for the study.”

5 copyedit issues flagged: mostly clarity, other, consistency.

Checked 17 references: 8 verified — 9 not checked.

Reproducibility

2 data/code links checked; 1 live.

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Adcurare Rigor Action ItemsFinal pass before journal submission

The manuscript is ready for submission after minor revisions. The most important fix is adding a data availability statement specifying how to access individual patient data (e.g., via a managed-access platform). Other high-priority items include naming the statistical software and version, and referencing the CONSORT reporting guideline. The copyedit issues (range formatting, phrasing) are minor and should be corrected.

1.
HIGHdata code
Add a data availability statement specifying how to access individual patient data (e.g., via a managed-access platform like YODA or a data-access committee) in a new 'Data Availability' section after the Discussion.
The current statement only points to the protocol, not the data; a data-sharing plan is expected for clinical trials.
2.
HIGHstatistics
Identify the statistical software and version used for all analyses (e.g., 'SAS version 9.4' or 'R version 4.3') in the Statistical Analysis subsection of Methods.
Software identification is a standard reporting requirement and is currently missing.
3.
HIGHreporting
Reference the CONSORT reporting guideline in the Methods section and submit the CONSORT checklist as a supplemental file.
Explicitly naming the reporting guideline improves transparency and is expected by many journals.
4.
MEDIUMdata code
State whether the analysis code is available upon request or will be deposited in a repository.
Code sharing supports reproducibility; even a statement of availability upon request is better than silence.
5.
MEDIUMdata code
Deposit de-identified MPXV sequence data in a public repository (e.g., GenBank, GISAID) and provide accession numbers.
Sequence data are a key resource; accession numbers enable verification and reuse.
6.
MEDIUMreporting
Add a statement on the verification of statistical test assumptions (e.g., proportional hazards for the Cox model) in the Statistical Analysis section or results.
Assumption verification is a standard part of statistical reporting and is currently not addressed.
7.
MEDIUMreporting
Clarify the handling of missing data and protocol deviations (e.g., ITT, per-protocol) in the Statistical Analysis section.
Outlier handling and missing data methods are important for assessing the robustness of the results.
8.
LOWcopyedit
Fix the range formatting in Results, paragraph 1: change 'range:1,10264' to 'range:1–10264' or 'range:1 to 10,264'.
The current formatting is ambiguous and appears to be a copyediting error.
9.
LOWcopyedit
Reword the sentence in Methods, Statistical Analysis: 'When applicable, censoring was applied on the confirmed recrudescence day' to 'Censoring was applied on the day of confirmed recrudescence, when applicable.'
The original phrasing is slightly awkward; the suggested revision improves clarity.
10.
LOWcopyedit
Ensure consistent capitalization of 'intention-to-treat' throughout the manuscript (currently 'intent-to-treat' and 'intention-to-treat' are both used).
Consistency in terminology improves readability and professionalism.
11.
LOWcopyedit
Clarify in Discussion, paragraph 5 that the sub-study evaluating inter-observer variability is a planned analysis, not yet reported.
The phrase 'is underway' could be misinterpreted as part of the current report; rephrasing avoids confusion.

Full text (26,196 chars)Analyzed: Jul 7, 2026

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Tecovirimat for Clade I MPXV Infection in the Democratic Republic of Congo.

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DOI

10.1056/NEJMoa2412439

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