A Randomised Clinical Trial of Azithromycin Versus Standard Care in Ambulatory COVID-19 – The ATOMIC2 Trial

Hinks, Timothy S C; Cureton, Lucy; Knight, Ruth; Wang, Ariel; Cane, Jennifer; Barber, Vicki S; Black, Joanna; Dutton, Susan; Melhorn, James; Jabeen, Maisha; Moss, Phil; Garlapati, Rajendar; Baron, Tanya; Johnson, Graham; Cantle, Fleur; Clarke, David D.; Elkhodair, Samer; Underwood, Jonathan; Lasserson, Daniel; Pavord, Ian; Morgan, Sophie; Richards, Duncan

doi:10.2139/ssrn.3827019

Cited by 3 publications

(4 citation statements)

References 22 publications

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“…The PRINCIPLE trial testing azithromycin in outpatients showed no evidence of benefit of azithromycin in nonhospitalised patients [ 51 ], but it is not included in the present meta-analysis focusing on hospitalised patients only. The ATOMIC2 trial by H inks et al [ 47 ] was included in the analysis, as patients were enrolled in hospital, although eligibility included the requirement to be eligible for ambulatory management. The COALITION study by C avalcanti et al [ 33 ] compared azithromycin and hydroxychloroquine compared to hydroxychloroquine or standard care.…”

Section: Resultsmentioning

confidence: 99%

“…We identified five studies [33,[47][48][49][50] with 9067 subjects, including one additional study [50] and one preprint [47] following publication of the guidelines. The PRINCIPLE trial testing azithromycin in outpatients showed no evidence of benefit of azithromycin in nonhospitalised patients [51], but it is not included in the present meta-analysis focusing on hospitalised patients only.…”

Section: Azithromycinmentioning

confidence: 99%

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The impact of therapeutics on mortality in hospitalised patients with COVID-19: systematic review and meta-analyses informing the European Respiratory Society living guideline

et al. 2021

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Hospitalised patients with coronavirus disease 2019 (COVID-19) have a high mortality rate. There are an increasing number of published randomised controlled trials for anti-inflammatory, anti-viral and other treatments. The European Respiratory Society Living Guidelines for the Management of Hospitalised Adults with COVID-19 were published recently, providing recommendations on appropriate pharmacotherapy.Patient, Intervention, Comparator and Outcomes questions for key interventions were identified by an international panel and systematic reviews were conducted to identify randomised controlled trials meeting the inclusion criteria. The importance of end-points were rated, and mortality was identified as the key “critical” outcome for all interventions. Random-effects meta-analysis was used to pool studies and provide effect estimates for the impact of treatments on mortality.Corticosteroids, hydroxychloroquine, azithromycin, remdesivir, anti-interleukin (IL)-6 monoclonal antibodies, colchicine, lopinavir/ritonavir and interferon-β have been reviewed.Our results found further evidence in support of the use of corticosteroids, particularly dexamethasone, and anti-IL-6 receptor monoclonal antibody therapy. These data support the need to identify additional therapies with beneficial effects on mortality.

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Section: Resultsmentioning

confidence: 99%

Section: Azithromycinmentioning

confidence: 99%

The impact of therapeutics on mortality in hospitalised patients with COVID-19: systematic review and meta-analyses informing the European Respiratory Society living guideline

et al. 2021

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“…After abstract screening and full-text reading, 152 RCTs were included in the analysis. All 152 RCTs were posted on the medRxiv server …”

Section: Resultsmentioning

confidence: 99%

Comparison of Preprint Postings of Randomized Clinical Trials on COVID-19 and Corresponding Published Journal Articles

et al. 2023

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ImportanceRandomized clinical trials (RCTs) on COVID-19 are increasingly being posted as preprints before publication in a scientific, peer-reviewed journal.ObjectiveTo assess time to journal publication for COVID-19 RCT preprints and to compare differences between pairs of preprints and corresponding journal articles.Evidence ReviewThis systematic review used a meta-epidemiologic approach to conduct a literature search using the World Health Organization COVID-19 database and Embase to identify preprints published between January 1 and December 31, 2021. This review included RCTs with human participants and research questions regarding the treatment or prevention of COVID-19. For each preprint, a literature search was done to locate the corresponding journal article. Two independent reviewers read the full text, extracted data, and assessed risk of bias using the Cochrane Risk of Bias 2 tool. Time to publication was analyzed using a Cox proportional hazards regression model. Differences between preprint and journal article pairs in terms of outcomes, analyses, results, or conclusions were described. Statistical analysis was performed on October 17, 2022.FindingsThis study included 152 preprints. As of October 1, 2022, 119 of 152 preprints (78.3%) had been published in journals. The median time to publication was 186 days (range, 17-407 days). In a multivariable model, larger sample size and low risk of bias were associated with journal publication. With a sample size of less than 200 as the reference, sample sizes of 201 to 1000 and greater than 1000 had hazard ratios (HRs) of 1.23 (95% CI, 0.80-1.91) and 2.19 (95% CI, 1.36-3.53) for publication, respectively. With high risk of bias as the reference, medium-risk articles with some concerns for bias had an HR of 1.77 (95% CI, 1.02-3.09); those with a low risk of bias had an HR of 3.01 (95% CI, 1.71-5.30). Of the 119 published preprints, there were differences in terms of outcomes, analyses, results, or conclusions in 65 studies (54.6%). The main conclusion in the preprint contradicted the conclusion in the journal article for 2 studies (1.7%).Conclusions and RelevanceThese findings suggest that there is a substantial time lag from preprint posting to journal publication. Preprints with smaller sample sizes and high risk of bias were less likely to be published. Finally, although differences in terms of outcomes, analyses, results, or conclusions were observed for preprint and journal article pairs in most studies, the main conclusion remained consistent for the majority of studies.

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“…Update 2022: Our literature review identified 5 randomised trials 78,[95][96][97][98] . Two of these are new to this updated analysis 97,98…”

Section: Pico 4: In Patients Hospitalised With Covid-19 Should Azithr...mentioning

confidence: 99%

Update June 2022: management of hospitalised adults with coronavirus disease 2019 (COVID-19): a European Respiratory Society living guideline

et al. 2022

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This is the early view version of an editorial detailing the latest update to the ERS living guideline on the management of hospitalised adults with COVID-19. The latest version of the guideline itself can be accessed as a supplementary PDF at the end of this early view PDF. When the guideline is finalised, it will replace the earlier version of the guideline with the original version accessible as a supplementary file, and at the same time this editorial will be published to alert readers to the updates that have been made.

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A Randomised Clinical Trial of Azithromycin Versus Standard Care in Ambulatory COVID-19 – The ATOMIC2 Trial

Cited by 3 publications

References 22 publications

The impact of therapeutics on mortality in hospitalised patients with COVID-19: systematic review and meta-analyses informing the European Respiratory Society living guideline

The impact of therapeutics on mortality in hospitalised patients with COVID-19: systematic review and meta-analyses informing the European Respiratory Society living guideline

Comparison of Preprint Postings of Randomized Clinical Trials on COVID-19 and Corresponding Published Journal Articles

Update June 2022: management of hospitalised adults with coronavirus disease 2019 (COVID-19): a European Respiratory Society living guideline

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