Effectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir and combinations thereof in hospitalized patients with COVID-19: a pragmatic, open-label randomized trial
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SciScore for 10.1101/2021.07.06.21260085: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: The study protocol and informed consent template were approved by the Universidad National de Colombia Ethics Committee and by the Institutional Review Boards of the participating hospitals (protocol’s details are provided in the Supplementary Material).
IRB: The study protocol and informed consent template were approved by the Universidad National de Colombia Ethics Committee and by the Institutional Review Boards of the participating hospitals (protocol’s details are provided in the Supplementary Material).
Field Sample Permit: The study was funded by the Colombian Ministry of Science and Technology and coordinated by the Clinical Research Institute at the Universidad Nacional de …SciScore for 10.1101/2021.07.06.21260085: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: The study protocol and informed consent template were approved by the Universidad National de Colombia Ethics Committee and by the Institutional Review Boards of the participating hospitals (protocol’s details are provided in the Supplementary Material).
IRB: The study protocol and informed consent template were approved by the Universidad National de Colombia Ethics Committee and by the Institutional Review Boards of the participating hospitals (protocol’s details are provided in the Supplementary Material).
Field Sample Permit: The study was funded by the Colombian Ministry of Science and Technology and coordinated by the Clinical Research Institute at the Universidad Nacional de Colombia; the generation of the random allocation sequence and the statistical analysis was carried out by the Department of Clinical Epidemiology and Biostatistics at the Pontificia Universidad Javeriana.Sex as a biological variable Pregnant women, patients taking any of the study medications in the last 7 days or with known allergy to them, or with a history of myopathy or rhabdomyolysis, hepatic, or renal failure or lung fibrosis, advanced or metastatic cancer, and those with score more than 3 on the frailty scale, were excluded. Randomization Trial design and oversight: This is a pragmatic open parallel-group multi-centre randomised controlled trial. Blinding not detected. Power Analysis Analysis: We estimated that a sample size of 814 patients (204 per treatment arm) would provide the trial with 80% power to detect an absolute difference of 10% compared with the standard of care arm in the incidence of the primary outcome, assuming that 5% of the participants in the treatment groups and 15% of those in the standard of care group would have an event (i.e., death through day 28).22,23 The hypothesis of no difference was tested at a two-tailed alpha level of 5%. Table 2: Resources
Software and Algorithms Sentences Resources The study was funded by the Colombian Ministry of Science and Technology and coordinated by the Clinical Research Institute at the Universidad Nacional de Colombia; the generation of the random allocation sequence and the statistical analysis was carried out by the Department of Clinical Epidemiology and Biostatistics at the Pontificia Universidad Javeriana. Colombiasuggested: NoneREDCap], Ver. 6.16 Vanderbilt University). REDCapsuggested: (REDCap, RRID:SCR_003445)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:Our study has some limitations. The number of patients included was lower than expected, affecting the precision of our results. Low recruitment was due partly to a high proportion of patients who refused to provide their consent to participate (33%), a cultural issue that should be analyzed. Also, the lack of additional funding prevented us from continuing the study and, it had to be stopped based on the second sample size scenario. Another problem was detection bias, as it was an open study. The effect is found in the proportion of non-adherence to treatment, ranging between 18% and 25% in the different study medication groups (Figure1). Considering various scenarios, the direction of this bias could favor the null hypothesis; consequently, the effect in terms of mortality reduction with the combined treatment could be accurate. In terms of generalizability, a significant number of patients on chronic treatment with statins were considered not eligible (37%) based on the exclusion criteria. Therefore, our findings are only relevant for patients in whom the use of statins is novel, which affects the pragmatic approach of the study. Moreover, the study was conducted under the usual conditions in hospitals (with high workloads and standard medication administration systems at each hospital), using an ITT approach analysis, and looking for the more useful treatment against the standard of care to help the clinical decision analysis.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04359095 Recruiting Effectiveness and Safety of Medical Treatment for SARS-CoV-2… 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.
Results from scite Reference Check: We found no unreliable references.
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