Remdesivir (ClinTrial)​

A Randomized, Double-Blind, Controlled Trial to Evaluate the Efficacy of Remdesivir Administration for 5 days and 10 days in Moderate and Severe COVID-19 Inpatients

Not Published

Background

COVID-19, first reported by China on December 31, 2019, rapidly spread globally and was officially declared a pandemic by the WHO on March 11, 2020. The virus primarily spreads through direct and indirect droplet transmission, with a high replication rate of 2 to 2.5. As of August 25, 2020, over 23 million confirmed cases and 817,040 deaths were reported worldwide. Despite extensive efforts, no definitive therapy for COVID-19 has been established. Clinical trials by Beigel et al. involving 1,063 patients revealed that Remdesivir significantly shortens patient recovery time compared to a placebo. Similar, though not statistically significant, results were found in a Chinese study. Remdesivir has been approved for COVID-19 treatment under specific conditions, with the FDA in the United States granting Emergency Use Authorization (EUA), and Indonesia’s BPOM following suit. However, Remdesivir is not yet included in Indonesia’s Ministry of Health’s COVID-19 Prevention and Control Guidelines but is considered an alternative treatment in protocols published by professional organizations, including the Indonesian Society of Respirology (PDPI), which recommends its use for a minimum of 5 days and a maximum of 10 days. Studies by Rezagholizadeh et al. suggest that a 5-day course of Remdesivir is as effective as a 10-day course, with fewer side effects, although Goldman et al. found no significant difference in efficacy between the two durations. This study aims to determine the differences in efficacy and safety between 5-day and 10-day Remdesivir regimens using various clinical, laboratory, and radiological parameters.

Information

This is a multicenter clinical trial in COVID-19 patients with moderate to severe degree in Persahabatan Central General Hospital, Islam Cempaka Putih Hospital, Yarsi Hospital to determine efficacy of 5-days course remdesivir and 10-days course remdesivir administration. The study objectives are to determine the safety by determining the proportion of patients with AE and SAE, and to determine effectiveness of remdesivir by determining proportion of patients who experienced clinical improvement and death. This study originally needed to enroll 284 subjects, but the study has been stopped by the sponsor (Litbangkes/Health Research and Development, Ministry of Health, Indonesia) as per January 2022.

Type of Study

Topic

Collaborator

Clinical Trial

COVID-19

Litbangkes RI dan Amarx