Azithromycin versus standard care in patients with mild-to-moderate COVID-19 (ATOMIC2): an open-label, randomised trial
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SciScore for 10.1101/2021.04.21.21255807: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial protocol was reviewed and approved by the UK Medicines and Healthcare products Regulatory Agency and an independent ethical committee (London – Brent Research Ethics Committee, Research Ethics Committee reference number 20/HRA/2105).
Consent: All patients provided electronic informed consent before randomisation.Sex as a biological variable not detected. Randomization Study design: ATOMIC2 was a prospective, open-label, two-arm, randomised superiority clinical trial of standard care and Azithromycin with standard care alone, conducted at 19 hospitals in the United Kingdom. Blinding Following the revision to the primary outcome and based on blinded data from the pilot phase, the … SciScore for 10.1101/2021.04.21.21255807: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial protocol was reviewed and approved by the UK Medicines and Healthcare products Regulatory Agency and an independent ethical committee (London – Brent Research Ethics Committee, Research Ethics Committee reference number 20/HRA/2105).
Consent: All patients provided electronic informed consent before randomisation.Sex as a biological variable not detected. Randomization Study design: ATOMIC2 was a prospective, open-label, two-arm, randomised superiority clinical trial of standard care and Azithromycin with standard care alone, conducted at 19 hospitals in the United Kingdom. Blinding Following the revision to the primary outcome and based on blinded data from the pilot phase, the definitive sample size was determined. Power Analysis Assuming a 15% rate of all cause hospitalisation or death in the standard care arm, we estimated a minimum of 276 participants providing primary end-point data, would provide 80% power and 5% (2-sided) significance to detect a difference from 15% to 5% in the Azithromycin arm, a relative reduction of 66%. Table 2: Resources
Software and Algorithms Sentences Resources Analyses were performed using Stata IC V15.1 (StataCorp LP, www.stata.com). StataCorpsuggested: (Stata, RRID:SCR_012763)Results from OddPub: Thank you for sharing your data.
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:A limitation of our trial is that it was open-label, due to the difficulty obtaining appropriate placebos early in the pandemic, and is therefore at risk of bias particularly on patient reported outcomes. However, our choice of hospitalisation and death as the primary outcome is unlikely to be markedly influenced by selection, detection or observer bias. Detection of hospitalisation episodes has benefitted from restricted movement during lockdowns, from use of regional and national electronic health records and by systematic contacting of all participants, with >95% follow-up. Moreover, a placebo effect from perceived benefits of treatment would tend towards a positive effect of azithromycin which was not observed. Knowledge of treatment allocation may also lead to a tendency to more antibiotic prescribing in the placebo group – an effect we observed – which would tend to prejudice against azithromycin as an antibiotic, although concomitant use of macrolides specifically was prohibited by the protocol. A second limitation is that, like other studies23, we used a clinical diagnosis for inclusion, rather than requiring PCR confirmation, and PCR data were not available on all participants – particularly at the early stages of the pandemic in the UK where limited testing capacity was directed to patients who needed admission to hospital. Whilst it is likely some participants who did not ultimately have COVID-19 may have been enrolled, this decision reflects the situation in many ...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04381962 Recruiting A Multicentre Open-label Two-arm Randomised Superiority Clin… 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.
Results from scite Reference Check: We found no unreliable references.
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