Early Start of Oral Clarithromycin Is Associated with Better Outcome in COVID-19 of Moderate Severity: The ACHIEVE Open-Label Single-Arm Trial
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SciScore for 10.1101/2020.12.22.20248753: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Patient population: ACHIEVE was an open-label non-randomized trial conducted in four study sites in tertiary hospitals in Greece (EudraCT number 2020-001882-36; National Ethics Committee approval 45/20; National Organization for Medicines approval ISO 36/20;
Consent: Written informed consent was provided by the patient or legal representative before screening.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Comparisons were performed by the Fisher’s exact test using confirmatory forward stepwise logistic regression analysis (IBM SPSS … SciScore for 10.1101/2020.12.22.20248753: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Patient population: ACHIEVE was an open-label non-randomized trial conducted in four study sites in tertiary hospitals in Greece (EudraCT number 2020-001882-36; National Ethics Committee approval 45/20; National Organization for Medicines approval ISO 36/20;
Consent: Written informed consent was provided by the patient or legal representative before screening.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Comparisons were performed by the Fisher’s exact test using confirmatory forward stepwise logistic regression analysis (IBM SPSS Statistics v.25.0). SPSSsuggested: (SPSS, RRID:SCR_002865)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 findings of the ACHIEVE study should be interpreted in the light of certain limitations. The study was designed in mid-March 2020 at the beginning of the pandemic in Greece. It was decided to endorse an open-label and single-arm design in an attempt to include (and benefit) as many patients as possible since no SOC was framed at that time period. The azithromycin plus hydroxychloroquine concurrent comparators were optimally matched without differences in baseline severity and co-administered treatment. When the study was started, most of the patients with COVID-19 hospitalized in the Greek Hospitals were co-administered azithromycin and hydroxychloroquine as an off-label treatment option. In the following months, emerging data showed that hydroxychloroquine does not affect the natural course of COVID-19 [18, 19]. As such, the comparison between the clarithromycin group and the azithromycin plus hydroxychloroquine group should be conceived as comparison between clarithromycin and azithromycin. In the randomized COALITION trial from Brazil, patients with moderate to severe COVID-19 were randomized to treatment with placebo (n=227), hydroxychloroquine (n=221) and a combination of hydroxychloroquine and azithromycin (n=217). The achievement of the primary endpoint was similar between the three groups of treatment [20]. The same group of investigators performed the COALITION II trial were patients were allocated to treatment with standard-of-care with (n=214) or without azithr...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04398004 Completed Anti-inflammatory Clarithromycin for Improving COVID-19 Infe… Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).
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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