The antibiotics azithromycin and doxycycline should not be used in the management of confirmed or suspected COVID-19, the Department of Health and Social Care (DHSC) has advised.
In an alert issued on 28 January 2021, the DHSC said NHS trusts must ensure that frontline medical, nursing, clinical and pharmacy teams are aware of the UK-wide recommendation to stop using azithromycin in the treatment of patients hospitalised with COVID-19, unless it is being used for other licensed indications, such as acute bacterial sinusitis, acute bacterial otitis media, pharyngitis, tonsillitis, and skin and soft tissue infections.
It added that GPs must also ensure that local primary care teams are aware that antimicrobials should not be used in the primary management of COVID-19, unless they are being used for other licensed indications.
The alert follows the publication of data from the Platform Randomised trial of Interventions against COVID-19 in older people (PRINCIPLE), which found that neither azithromycin nor doxycycline benefitted patients aged over 50 years in the early stages of COVID-19, who were treated at home.
Researchers had investigated azithromycin and doxycycline as separate treatments to see if they could help patients aged over 50 years with early stage COVID-19 to recover more quickly at home, or prevent the need for hospital admission.
However, interim data analyses from both arms suggested that neither treatment reduced hospitalisation or death compared to standard care, and found that there was a low probability of a meaningful benefit to self-reported recovery time.
Early results from the Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial also showed that the use of azithromycin in patients hospitalised with COVID-19 had no significant clinical benefit.
A preliminary analysis of data from the trial showed no significant difference in the primary endpoint of 28-day mortality (19% azithromycin vs. 19% usual care).
Researchers also found no beneficial effects on the risk of progression to mechanical ventilation or length of hospital stay. The azithromycin arm of the RECOVERY trial was closed on 27 November 2020 after it was confirmed that sufficient patients had been enrolled to establish efficacy data.
“Azithromycin and doxycycline have anti-inflammatory, antibacterial and possibly antiviral effects, and so were considered as potential treatments for COVID-19 in the community,” said Chris Butler, co-lead of the PRINCIPLE trial.
“While we are completing the analysis of the full range of study outcomes, and in different patient groups, our findings show that a three-day course of azithromycin or a seven-day course of doxycycline has no important clinical benefit in terms of the time taken to feeling recovered, and so will not help most patients with COVID-19 in the early stages of their illness.”
For more information on clinical trials investigating treatments and preventative measures for COVID-19, read our briefing on everything you need to know about the COVID-19 therapy trials.