Background Real-world data on safety and clinical outcomes of remdesivir in COVID-19 management is scant. We present findings of data analysis conducted for assessing the safety and clinical outcomes of remdesivir treatment for COVID-19 in India. Methods This retrospective analysis used data from an active surveillance programme database of hospitalised patients with COVID-19 who were receiving remdesivir. Results Of the 2329 patients included, 67.40% were men. Diabetes (29.69%) and hypertension (20.33%) were the most common comorbidities. At remdesivir initiation, 2272 (97.55%) patients were receiving oxygen therapy. Remdesivir was administered for 5 days in 65.38% of patients. Antibiotics (64.90%) and steroids (47.90%) were the most common concomitant medications. Remdesivir was overall well tolerated, and total 119 adverse events were reported; most common were nausea and vomiting in 45.40% and increased liver enzymes in 14.28% patients. 84% of patients were cured/improved, 6.77% died and 9.16% showed no improvement in their clinical status at data collection. Subgroup analyses showed that the mortality rate was significantly lower in patients < 60 years old than in those > 60 years old. Amongst patients on oxygen therapy, the cure/improvement rate was significantly higher in those receiving standard low-flow oxygen than in those receiving mechanical ventilation, non-invasive ventilation, or high-flow oxygen. Factors that were associated with higher mortality were age > 60 years, cardiac disease, diabetes high flow oxygen, non-invasive ventilation and mechanical ventilation. Conclusion Our analysis showed that remdesivir is well tolerated and has an acceptable safety profile. The clinical outcome of cure/improvement was 84%, with a higher improvement in patients < 60 years old and on standard low-flow oxygen. Supplementary Information The online version contains supplementary material available at 10.1186/s12879-021-07004-8.
【저자키워드】 COVID-19, Remdesivir, Retrospective studies, Retrospective analysis, Active surveillance, 【초록키워드】 Mortality, mechanical ventilation, India, Comorbidities, Remdesivir, oxygen, Antibiotics, diabetes, hypertension, database, Steroids, clinical status, Clinical outcome, management, adverse event, Patient, Data analysis, Oxygen therapy, non-invasive ventilation, Hospitalised patients, mortality rate, cardiac disease, patients, safety profile, liver enzymes, Analysis, Data collection, steroid, nausea and vomiting, High-flow oxygen, Subgroup analyses, Factor, supplementary material, nausea, concomitant medications, vomiting, significantly lower, increased liver enzymes, low-flow oxygen, Administered, men, Result, died, conducted, receiving, significantly higher, hospitalised patient, diabete, increased liver enzyme, Subgroup analysis, treatment for COVID-19, used data, with COVID-19, 【제목키워드】 Safety, Remdesivir, database, hospitalised,