Evaluating the Therapeutic Effect of Remdesivir on COVID-19 Patients: A Single-Arm and Non-randomized Clinical Trial

Abstract

Background: Remdesivir (GS-5734) has demonstrated in vitro activity against SARS-CoV-1 and the Middle East Respiratory Syndrome. Its effectiveness against coronavirus disease 2019 (COVID-19) infection remains under debate. Objectives: This single-arm, non-randomized clinical trial aims to assess the therapeutic effect of remdesivir on COVID-19 patients. Methods: A total of 71 eligible voluntary patients (aged ≥ 18 years) who exhibited specified symptoms of COVID-19 and tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) via RT-PCR and CT scan were included in this trial. Patients received intravenous remdesivir at a dose of 200 mg on the first day, followed by 100 mg on the subsequent 4 days, administered as single daily infusions over 5 days. The length of in-hospital stay (LOS), recovery period of COVID-19 symptoms, two-month mortality post-admission, and frequency of remdesivir-related side effects were statistically evaluated. Results: The majority of patients were male (63.4% vs. 36.6% female) and had underlying diseases (60.6%). A significant trend in recovery time was observed for all symptoms (P < 0.001) based on the Friedman test. Additionally, a significant decreasing trend was noted in the rate of intensive care unit (ICU) attendance (P < 0.001). The mean ± SD LOS was 6.55 ± 3.81 days, with most patients (59.15%) recovering and being discharged in less than 7 days. Fourteen patients (19.72%) died, and no side effects were observed. Conclusions: Our findings indicate a significant reduction in recovery time for all symptoms and a decrease in ICU attendance rates among COVID-19 patients treated with remdesivir for 5 days. However, the mortality rate was not significantly improved by remdesivir. Male gender and underlying disease may be potential risk factors associated with COVID-19 infection. Incorporating a randomized control/placebo group into the single-arm trial is recommended to enhance the reliability of results.