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Source: United Kingdom – Executive Government & Departments

A preprint, an unpublished non-peer reviewed study, from the RECOVERY trial, reports no benefit from azithromycin, a widely used antibiotic, in patients hospitalised with COVID-19.

Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:

“The RECOVERY trial is now well known as a platform for testing a variety of treatments and has been able to recruit large numbers of patients with Covid-19 who are in hospital.  It has shown that the trial design is capable of detecting benefits for dexamethasone, and shown convincingly that the other treatments it has tested in hospitalised patients show no or the possibility of only small, benefit in terms of mortality or length of hospital stay.  It is a well-designed and conducted trial answering relatively simple questions with recruitment of large numbers of patients.  It can give reliable and precise answers.

“The antibiotic azithromycin has been suggested as having benefits, particularly when used in combination with hydroxychloroquine, but RECOVERY has only studied them separately.  Neither have been shown to have benefit in terms of mortality, and in the randomised trials conducted by others on the combination of the two drugs no notable benefits have been seen.

“This trial report, while preliminary, makes it clear that as the authors say “The results of this large randomised trial show that azithromycin is not an effective treatment for patients hospitalised with COVID-19. Allocation to azithromycin was not associated with reductions in mortality, duration of hospitalisation or the risk of being ventilated or dying for those not on ventilation at baseline.”

“Those who should definitely receive the antibiotic for a bacterial infection or who should definitely not receive it (because of underlying health conditions) were excluded.  It shows that patients who could receive it as an option showed neither benefit nor harm.”

Dr Sheuli Porkess, Chair of the Policy and Communications Group, Faculty of Pharmaceutical Medicine:

“This news shows the ongoing benefit of having clinical trial platforms which are able to provide robust answers to questions about medicines for COVID-19.

“Whilst it is disappointing that azithromycin did not show any benefit for patients who had been hospitalised with COVID-19, this information is important to guide clinicians as they make decisions about how to treat patients.

“Having this information is particularly important in the case of azithromycin as azithromycin is an antibiotic and antibiotics should only be used where there is a clear need, in order to minimise antimicrobial resistance.”

Dr Stephen Griffin, Associate Professor in the School of Medicine, University of Leeds, said:

“Once again, this preliminary analysis of an arm of the RECOVERY trial demonstrates the value of robust RCTs in the assessment of repurposed therapies for COVID.  Whilst Azithromycin, sometimes combined with hydroxychloroquine, has been proposed as a therapy in smaller studies and anecdotal accounts, it has never been clear exactly what its mode of action might be versus SARS-CoV2, or whether its anti-inflammatory properties are effective in combatting the immune pathology associated with severe disease.  Like hydroxychloroquine, it is now clear that healthcare professionals can, with some confidence, stop prescribing this drug to hospitalised patients and instead focus upon medicines with proven benefit.”

Preprint (not a paper): ‘Azithromycin in Hospitalised Patients with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial’ by the RECOVERY Collaborative Group was posted on medRxiv at 13:00 UK time on Monday 14 December 2020.  This work is not peer-reviewed.

All our previous output on this subject can be seen at this weblink:

Declared interests

Prof Stephen Evans: “No conflicts of interest.  I am funded (one day per week) by LSHTM.  They get funding from various companies, including Astra Zeneca and GSK but I am not funded by them, I have no involvement in obtaining funding from them and I am not an investigator on any grants obtained from them.  I am the statistician to the ‘meta-Data Safety and Monitoring Board’ for CEPI.  I am paid for my attendance at those meetings and will be paid expenses for travel if that occurs.”

Dr Sheuli Porkess: “Dr Sheuli Porkess is Director of Actaros Consultancy Ltd. and clients include the Association of the British Pharmaceutical Industry.”

Dr Stephen Griffin: “No conflicts.”

MIL OSI United Kingdom