Does early combination vs. Monotherapy improve clinical outcomes of clinically extremely vulnerable patients with COVID-19? Results from a retrospective propensity-weighted analysis
Mazzitelli Maria, Alberto Enrico Maraolo, Claudia Cozzolino, Lolita Sasset, Anna Ferrari, Monica Basso, Eleonora Vania, Nicola Bonadiman, Vincenzo Scaglione, Anna Maria Cattelan
European Journal of Medical Research, doi:10.1186/s40001-024-02062-5
Background The potential efficacy of early combination therapy, based on an antiviral plus a monoclonal antibody, for COVID-19 in severely immunocompromised patients is matter of debate. Objectives Our aim was to describe the impact on clinical outcomes of COVID-19 treatments in severely immunocompromised individuals, evaluating differences between a combination and a monotherapy.
Methods We included severely immunocompromised outpatients with mild-to-moderate COVID-19 who received an early treatment (either monotherapy with nirmatrelvir/ritonavir or remdesivir or the combination of an antiviral plus sotrovimab). We then assessed differences between the two treatment strategies on three main outcomes (30day mortality, access to emergency department, hospitalization), separately and as a composite by using a propensity score weighted (PSW) approach. Results Eighty one severely immunocompromised patients were included, 39 receiving early combination therapy and 42 receiving monotherapy. No significant difference was observed in the 30-day mortality rate and hospitalization rate between subjects in the two groups, while access to the emergency department following treatment administration was significantly higher in people who received a combination therapy. After applying the PSW, it was observed that combination therapy impacted favourably on the composite outcome, in a statistically significant fashion. In addition, PSW approach for mortality showed that age was the only significant factor influencing the death as stand-alone outcome.
Conclusions Early combination therapy showed a favourable impact on a composite outcome (including mortality, hospitalizations and access to emergency department) in severely immunocompromised hosts who were all vaccinated. However, further studies are needed to support our results.
Supplementary Information The online version contains supplementary material available at https:// doi . org/ 10. 1186/ s40001-024-02062-5.
Supplementary Material 1 Author contributions M.M. conceived the study. A.M. performed statistical analysis. M.M. and A.M wrote the draft of the manuscript. C.C., M.B., L.S., A.F, V.S., N.B. and E.V. curated and collected the data. A.M.C. supervised the project. All authors reviewed, approved the final version of the manuscript, and by having access to all the data had final responsibility for the decision to submit this paper for publication.
Declarations Ethics approval and consent to participate Study protocol was approved by Local Ethic Committee (n. AOP 0002323, January 1rst, 2022). Each patient was requested to sign written informed consent for participation.
Competing interests
Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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