Background The effect of antibiotics on patient-important outcomes in non-severe (NS) and severe or critical (SC) COVID-19 is unclear. We aimed to systematically review and meta-analyse the available evidence on the impact of antibiotic use on clinical outcomes in these patient groups. Methods We included randomised controlled trials (RCTs) published between 2019 and 2025 comparing antibiotics plus standard of care (SoC) versus SoC alone in COVID-19 patients, reporting at least one prespecified outcome. Risk of bias was assessed using the Cochrane RoB2.0 tool. Absolute effects were generally estimated by applying pooled relative risk to baseline risks; for low-event outcomes, pooled risk differences (RDs) were used. Mortality in the NS-COVID-19 group was stratified by baseline risk as high (6%), moderate (3%), or low (0·5%). Certainty of evidence was assessed using GRADE. This review was prospectively registered in PROSPERO (CRD42023454933). Findings Of 54 918 identified studies, 11 RCTs met our eligibility criteria. For NS-COVID-19, antibiotic use did not reduce mortality (RD zero fewer per 1000; high risk 95% CI −27 to 27; moderate risk −19 to 19, both low certainty; low risk −8 to 8, moderate certainty), hospitalisation (two fewer per 1000; −16 to 18, moderate certainty), or invasive mechanical ventilation (six fewer per 1000; −12 to 12, high certainty), and serious adverse events (SAEs) did not differ. For SC-COVID-19, antibiotic use might have reduced mortality (RD six fewer per 1000, 95% CI −21 to 13, low certainty) but did not affect invasive mechanical ventilation (seven fewer per 1000; −19 to 7, moderate certainty) or SAEs (three fewer per 1000; −10 to 6, high certainty). Interpretation Use of antibiotics is unlikely to improve patient-important outcomes in individuals with NS-COVID-19 or SC-COVID-19. Consistent with these findings, the 2025 WHO guidelines recommend against antibiotics in patients with low suspicion of bacterial infection and emphasise judicious use in COVID-19 management. Funding None.
Effects of antibiotic treatment on clinical outcomes in patients with COVID-19: a systematic review and meta-analysis
Dona, Daniele;Brigadoi, Giulia;Liberati, Cecilia;Giaquinto, Carlo;
2026
Abstract
Background The effect of antibiotics on patient-important outcomes in non-severe (NS) and severe or critical (SC) COVID-19 is unclear. We aimed to systematically review and meta-analyse the available evidence on the impact of antibiotic use on clinical outcomes in these patient groups. Methods We included randomised controlled trials (RCTs) published between 2019 and 2025 comparing antibiotics plus standard of care (SoC) versus SoC alone in COVID-19 patients, reporting at least one prespecified outcome. Risk of bias was assessed using the Cochrane RoB2.0 tool. Absolute effects were generally estimated by applying pooled relative risk to baseline risks; for low-event outcomes, pooled risk differences (RDs) were used. Mortality in the NS-COVID-19 group was stratified by baseline risk as high (6%), moderate (3%), or low (0·5%). Certainty of evidence was assessed using GRADE. This review was prospectively registered in PROSPERO (CRD42023454933). Findings Of 54 918 identified studies, 11 RCTs met our eligibility criteria. For NS-COVID-19, antibiotic use did not reduce mortality (RD zero fewer per 1000; high risk 95% CI −27 to 27; moderate risk −19 to 19, both low certainty; low risk −8 to 8, moderate certainty), hospitalisation (two fewer per 1000; −16 to 18, moderate certainty), or invasive mechanical ventilation (six fewer per 1000; −12 to 12, high certainty), and serious adverse events (SAEs) did not differ. For SC-COVID-19, antibiotic use might have reduced mortality (RD six fewer per 1000, 95% CI −21 to 13, low certainty) but did not affect invasive mechanical ventilation (seven fewer per 1000; −19 to 7, moderate certainty) or SAEs (three fewer per 1000; −10 to 6, high certainty). Interpretation Use of antibiotics is unlikely to improve patient-important outcomes in individuals with NS-COVID-19 or SC-COVID-19. Consistent with these findings, the 2025 WHO guidelines recommend against antibiotics in patients with low suspicion of bacterial infection and emphasise judicious use in COVID-19 management. Funding None.
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