BMC infectious diseases · 2026
Effectiveness of oral and inhaled repurposed and antiviral pharmaceutical treatments for acute SARS-CoV-2 in outpatient settings: a systematic review of 124 randomized trials.
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Hosseini Banafshe, Pablo Lesley Anne, Piszczek Jolanta, Keynan Yoav, Daley Peter, Skidmore Becky, Pinto Andrew D
Аннотация
BACKGROUND: Outpatient therapeutics for SARS-CoV-2 remain critical to reducing disease severity, preventing hospitalization, and mitigating long-term complications, yet evidence across trials has been fragmented and evolving.
OBJECTIVE: To systematically identify and evaluate the effectiveness of oral or inhaled pharmaceutical treatments, including repurposed and antiviral therapies, for acute SARS-CoV-2 infection in adult patients managed in outpatient settings.
METHODS: Comprehensive peer-reviewed searches were conducted in several databases for studies published by March 2024. We included randomized controlled trials evaluating oral or inhaled therapeutics administered to adults with acute SARS-CoV-2 infection in outpatient settings and excluded non-randomized and observational studies. Outcomes of interest included severe clinical outcomes. Random-effects meta-analyses were performed where feasible.
RESULTS: A total of 124 randomized controlled trials evaluating 137 therapeutics across 35 countries were included. Most interventions were repurposed agents (n = 88), with 33 antiviral and three combination regimens. Molnupiravir shortened time to recovery and reduced hospitalization in a subgroup pool of unvaccinated, higher-risk outpatients (OR 0.68, 95% CI 0.52-0.89), although this effect attenuated when mostly vaccinated patients was included (OR 0.83, 95% CI 0.58-1.19). Inhaled budesonide and metformin showed modest or setting-specific benefits, while most repurposed drugs, including fluvoxamine, ivermectin, and hydroxychloroquine, had no consistent clinical impact. Safety profiles were class-typical with no new signals identified.
CONCLUSIONS: Most repurposed and antiviral therapies evaluated in outpatient COVID-19 trials showed no consistent benefit for severe clinical outcomes. Modest or setting-specific effects were observed for inhaled budesonide, metformin, and molnupiravir, with molnupiravir's effect on hospitalization most evident in unvaccinated, higher-risk outpatients and unreplicated for mortality.
CLINICAL TRIAL NUMBER: Not applicable.
OBJECTIVE: To systematically identify and evaluate the effectiveness of oral or inhaled pharmaceutical treatments, including repurposed and antiviral therapies, for acute SARS-CoV-2 infection in adult patients managed in outpatient settings.
METHODS: Comprehensive peer-reviewed searches were conducted in several databases for studies published by March 2024. We included randomized controlled trials evaluating oral or inhaled therapeutics administered to adults with acute SARS-CoV-2 infection in outpatient settings and excluded non-randomized and observational studies. Outcomes of interest included severe clinical outcomes. Random-effects meta-analyses were performed where feasible.
RESULTS: A total of 124 randomized controlled trials evaluating 137 therapeutics across 35 countries were included. Most interventions were repurposed agents (n = 88), with 33 antiviral and three combination regimens. Molnupiravir shortened time to recovery and reduced hospitalization in a subgroup pool of unvaccinated, higher-risk outpatients (OR 0.68, 95% CI 0.52-0.89), although this effect attenuated when mostly vaccinated patients was included (OR 0.83, 95% CI 0.58-1.19). Inhaled budesonide and metformin showed modest or setting-specific benefits, while most repurposed drugs, including fluvoxamine, ivermectin, and hydroxychloroquine, had no consistent clinical impact. Safety profiles were class-typical with no new signals identified.
CONCLUSIONS: Most repurposed and antiviral therapies evaluated in outpatient COVID-19 trials showed no consistent benefit for severe clinical outcomes. Modest or setting-specific effects were observed for inhaled budesonide, metformin, and molnupiravir, with molnupiravir's effect on hospitalization most evident in unvaccinated, higher-risk outpatients and unreplicated for mortality.
CLINICAL TRIAL NUMBER: Not applicable.