A Cluster-Randomized Trial of Hydroxychloroquine for Prevention of Covid-19
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SciScore for 10.1101/2020.07.20.20157651: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: 13 The study protocol and subsequent amendments, available at NEJM.org, were approved by the institutional review board of Hospital Germans Trias Pujol, and the Spanish Agency of Medicines and Medical Devices.
Consent: All participants provided written informed consent.Randomization The primary efficacy analysis was performed on the intention-to-treat (ITT) population, which included all randomized subjects with complete outcome data. Blinding not detected. Power Analysis STATISTICAL ANALYSIS: With an enrollment target of 95 clusters per trial group16 —15 participants per cluster and intraclass correlation of 1.0— the initial design yielded 90% power to detect … SciScore for 10.1101/2020.07.20.20157651: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: 13 The study protocol and subsequent amendments, available at NEJM.org, were approved by the institutional review board of Hospital Germans Trias Pujol, and the Spanish Agency of Medicines and Medical Devices.
Consent: All participants provided written informed consent.Randomization The primary efficacy analysis was performed on the intention-to-treat (ITT) population, which included all randomized subjects with complete outcome data. Blinding not detected. Power Analysis STATISTICAL ANALYSIS: With an enrollment target of 95 clusters per trial group16 —15 participants per cluster and intraclass correlation of 1.0— the initial design yielded 90% power to detect a difference of 10% in the incidence, with expected incidence of 15% in the control arm. Sex as a biological variable not detected. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:The study has some limitations. Unlike the common procedure in clinical trials, the informed consent signature took place after cluster-randomization. Nevertheless, allocation was revealed to participants after consent signature, therefore we believe the allocation concealment strategy was appropriate to prevent study participants from choosing to participate or not to participate. Owing to the urgency, the trial could not be masked with a placebo, which affected the rate of AE declared (AEs are not commonly reported in the control, non-placebo group), but it did not affect the attrition numbers in the control arm. However, it is worth mentioning that the laboratory staff who performed PCR tests remained unaware of the allocation of each sample. Despite the promising in-vitro results that placed HCQ among the leading candidates for Covid-19 treatment and prophylaxis, 23–25 to date there is no strong argument to suggest that HCQ is effective. We provide high-quality evidence on the lack of efficacy of postexposure prophylaxis therapy with HCQ to prevent Covid-19 disease or SARS-CoV-2 infection. The data presented in this report is particularly valuable for the scientific community and policymakers involved in controlling the pandemic at the population level. Our findings encourage directing efforts to other antiviral candidates for postexposure prophylaxis.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04304053 Completed Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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SciScore for 10.1101/2020.07.20.20157651: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement 13 The study protocol and subsequent amendments, available at NEJM.org, were approved by the institutional review board of Hospital Germans Trias Pujol, and the Spanish Agency of Medicines and Medical Devices. Randomization Clusters were randomized to receive no specific therapy (control arm) or HCQ 800mg once, followed by 400mg daily for 6 days (intervention arm). Blinding not detected. Power Analysis STATISTICAL ANALYSIS With an enrollment target of 95 clusters per trial group16 ―15 participants per cluster and intraclass correlation of 1.0― the initial design yielded 90% power to detect a difference of 10% in the incidence, with expected incidence of … SciScore for 10.1101/2020.07.20.20157651: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement 13 The study protocol and subsequent amendments, available at NEJM.org, were approved by the institutional review board of Hospital Germans Trias Pujol, and the Spanish Agency of Medicines and Medical Devices. Randomization Clusters were randomized to receive no specific therapy (control arm) or HCQ 800mg once, followed by 400mg daily for 6 days (intervention arm). Blinding not detected. Power Analysis STATISTICAL ANALYSIS With an enrollment target of 95 clusters per trial group16 ―15 participants per cluster and intraclass correlation of 1.0― the initial design yielded 90% power to detect a difference of 10% in the incidence, with expected incidence of 15% in the control arm. Sex as a biological variable not detected. Table 2: Resources
Data from additional tools added to each annotation on a weekly basis.
About SciScore
SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore is not a substitute for expert review. SciScore checks for the presence and correctness of RRIDs (research resource identifiers) in the manuscript, and detects sentences that appear to be missing RRIDs. SciScore also checks to make sure that rigor criteria are addressed by authors. It does this by detecting sentences that discuss criteria such as blinding or power analysis. SciScore does not guarantee that the rigor criteria that it detects are appropriate for the particular study. Instead it assists authors, editors, and reviewers by drawing attention to sections of the manuscript that contain or should contain various rigor criteria and key resources. For details on the results shown here, including references cited, please follow this link.
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