A retrospective real-world study of early short-course remdesivir in non-hospitalized COVID-19 patients at high risk for progression: low rate of hospitalization or death, regardless of immunocompetence status

José Manuel Ramos-Rincón; Héctor Pinargote-Celorio; Jara Llenas-García; Oscar Moreno-Pérez; Inmaculada González-Cuello; Pilar Gonzalez-de-la-Aleja; Belén Martínez-López; Sergio Reus; María García-López; Juan Carlos Rodríguez; Vicente Boix; Esperanza Merino

doi:10.3389/fphar.2023.1218650

A retrospective real-world study of early short-course remdesivir in non-hospitalized COVID-19 patients at high risk for progression: low rate of hospitalization or death, regardless of immunocompetence status

Front Pharmacol. 2023 Oct 10:14:1218650. doi: 10.3389/fphar.2023.1218650. eCollection 2023.

Authors

José Manuel Ramos-Rincón^{1

2}, Héctor Pinargote-Celorio³, Jara Llenas-García^{2

4}, Oscar Moreno-Pérez^{2

5}, Inmaculada González-Cuello⁴, Pilar Gonzalez-de-la-Aleja³, Belén Martínez-López⁴, Sergio Reus^{2

3}, María García-López⁴, Juan Carlos Rodríguez^{2

6}, Vicente Boix^{2

3}, Esperanza Merino^{2

3}

Affiliations

¹ Internal Medicine Department, Dr. Balmis General University Hospital-Alicante Institute of Health and Biomedical Research (ISABIAL), Alicante, Spain.
² Clinical Medicine Department, Miguel Hernández University, Elche, Spain.
³ Unit of Infectious Diseases Dr. Balmis General University Hospital-Alicante Institute of Health and Biomedical Research (ISABIAL), Alicante, Spain.
⁴ Internal Medicine Service Vega Baja Hospital-Foundation for the Promotion of Health and Biomedical Research of the Valencian Community (FISABIO), Valencia, Spain.
⁵ Endocrinology Department Dr. Balmis General University Hospital-Alicante Institute of Health and Biomedical Research (ISABIAL), Alicante, Spain.
⁶ Microbiology Service Dr. Balmis General University Hospital-Alicante Institute of Health and Biomedical Research (ISABIAL), Alicante, Spain.

Abstract

Introduction: The evidence for remdesivir therapy in immunocompromised patients is scarce. To evaluate remdesivir (RDV) effectiveness and safety in COVID-19 outpatients at high risk for progression in a real-world setting, we compare the outcome in immunocompromised (IC) patients with that in non-immunocompromised patients. Methods: Two hospitals conducted a retrospective study of all adult patients with mild-to-moderate SARS-CoV-2 infection at high risk for disease progression who were treated as outpatients with a 3-day course of RDV (1st January-30th September 2022). The primary effectiveness endpoint was a composite of any cause of hospitalization or death by day 30. A multiple logistic regression model was built to explore the association between immune status and clinical outcome, estimating adjusted odds ratios [aORs (95% CI)]. Results: We have included 211 patients, of which 57% were males, with a median age of 65 years (IQR 53-77), 70.1% were vaccinated (three or four doses), and 61.1% were IC. The median duration of symptoms before RDV treatment was 3 days (IQR 2-5). During follow-up, 14 (6.6%) patients were hospitalized, of which 6 (2.8%) were hospitalized for COVID-19 progression. No patient required mechanical ventilation, and two patients died (non-COVID-19-related). After accounting for potential confounders, only anti-CD20 treatment was associated with the composed outcome [aOR 5.35 (1.02-27.5, 95% CI)], whereas the immunocompetence status was not [aOR 1.94 (0.49-7.81, 95% CI)]. Conclusion: Early COVID-19 outpatient treatment with a 3-day course of remdesivir in vaccinated patients at high risk for disease progression during the Omicron surge had a good safety profile. It was associated with a low rate of all-cause hospitalization or death, regardless of immunocompetence status.

Keywords: SARS-CoV-2 early treatment; hospitalization SARS-CoV-2 infection; immunosupressed SARS-CoV2 treatment; outpatient SARS-CoV-2 treatment; remdesivir.