Abstract
Remdesivir (RDV) reduces time to clinical improvement in hospitalized COVID -19 patients requiring supplemental oxygen. Dexamethasone improves survival in those requiring oxygen support. Data is lacking on the efficacy of combination therapy in patients on mechanical ventilation. We analyzed for comparative outcomes between Corticosteroid (CS) therapy with combined Corticosteroid and Remdesivir (CS-RDV) therapy. We conducted an observational cohort study of patients aged 18 to 90 with COVID-19 requiring ventilatory support using TriNetX (COVID-19 Research Network) between January 20, 2020, and February 9, 2021. We compared patients who received at least 48 hours of CS-RDV combination therapy to CS monotherapy. The primary outcome was 28-day all-cause mortality rates in propensity-matched (PSM) cohorts. Secondary outcomes were Length of Stay (LOS), Secondary Bacterial Infections (SBI), and MRSA (Methicillin-Resistant Staphylococcus aureus), and Pseudomonas infections. We used univariate and multivariate Cox proportional hazards models and stratified log-rank tests. Of 388 patients included, 91 (23.5%) received CS-RDV therapy, and 297 (76.5%) received CS monotherapy. After propensity score matching, with 74 patients in each cohort, all-cause mortality was 36.4% and 29.7% in the CS-RDV and CS therapy, respectively (P = 0.38). We used a Kaplan-Meier with a log-rank test on follow up period (P = 0.23), and a Hazards Ratio model (P = 0.26). SBI incidence was higher in the CS group (13.5% vs. 35.1%, P = 0.02) with a similar LOS (13.4 days vs. 13.4 days, P = 1.00) and similar incidence of MRSA/Pseudomonas infections (13.5% vs. 13.5%, P = 1.00) in both the groups. Therefore, CS-RDV therapy is non-inferior to CS therapy in reducing 28-day all-cause in-hospital mortality but associated with a significant decrease in the incidence of SBI in critically ill COVID-19 patients.
Highlights
COVID-19 dominated 2020, emerging as a global pandemic, created havoc since its emergence as a zoonotic disease in China, 2019, causing death surge and economic devastation
RDV, a repurposed antiviral agent, is currently the only drug approved by the Food and Drug Administration (FDA) to treat COVID-19 hospitalized patients who require supplemental oxygen [1]
The TriNetX network contains data provided by participating Healthcare Organizations (HCOs), each of which represents and warrants that it has all necessary rights, consents, approvals, and authority to provide the data to TriNetX under a Business Associate Agreement (BAA), so long as their name remains anonymous as a data source and their data are utilized for research purposes
Summary
COVID-19 dominated 2020, emerging as a global pandemic, created havoc since its emergence as a zoonotic disease in China, 2019, causing death surge and economic devastation. No antiviral agents were shown to be effective, especially in COVID-19 illness requiring ventilatory support associated with high mortality rates. RDV, a repurposed antiviral agent, is currently the only drug approved by the Food and Drug Administration (FDA) to treat COVID-19 hospitalized patients who require supplemental oxygen [1]. The results were primarily based on the multinational, double-blind, randomized controlled trial that showed a reduction in clinical recovery time with RDV use in hospitalized patients with severe disease [2]. Dexamethasone, a glucocorticoid, has been found to improve survival in hospitalized patients who require any oxygen support [3], and its use was strongly recommended
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