Safety and clinical outcomes of remdesivir in hospitalised COVID-19 patients: a retrospective analysis of active surveillance database

BMC Infectious Diseases

Kabil Kalathingal¹  Jaideep Gogtay²  Sandesh Sawant³  Rohit Malabade⁴  Vaishali Gupte⁴  Rashmi Hegde⁴  Sonali Jadhav⁵ 

[1] Drug Safety, Cipla Ltd., Mumbai, India;Global Chief Medical Officer, Cipla Ltd., Mumbai, India;Head Clinical Research, Cipla Ltd., Mumbai, India;Medical Services, Cipla Ltd., Mumbai, India;Medical Services, Clinical Trial Group, Cipla Ltd., Mumbai, India;

关键词: Remdesivir;    COVID-19;    Retrospective studies;    Retrospective analysis;    Active surveillance;   

DOI  :  10.1186/s12879-021-07004-8

来源: Springer

【 摘 要 】

BackgroundReal-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.MethodsThis retrospective analysis used data from an active surveillance programme database of hospitalised patients with COVID-19 who were receiving remdesivir.ResultsOf 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.ConclusionOur 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.

【 授权许可】

CC BY