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Safety and clinical outcomes of remdesivir in hospitalised COVID-19 patients: a retrospective analysis of active surveillance database.
Gupte, Vaishali; Hegde, Rashmi; Sawant, Sandesh; Kalathingal, Kabil; Jadhav, Sonali; Malabade, Rohit; Gogtay, Jaideep.
  • Gupte V; Medical Services, Cipla Ltd., Mumbai, India. dr.gupte@Cipla.com.
  • Hegde R; Medical Services, Cipla Ltd., Mumbai, India.
  • Sawant S; Head Clinical Research, Cipla Ltd., Mumbai, India.
  • Kalathingal K; Drug Safety, Cipla Ltd., Mumbai, India.
  • Jadhav S; Medical Services, Clinical Trial Group, Cipla Ltd., Mumbai, India.
  • Malabade R; Medical Services, Cipla Ltd., Mumbai, India.
  • Gogtay J; Global Chief Medical Officer, Cipla Ltd., Mumbai, India.
BMC Infect Dis ; 22(1): 1, 2022 Jan 04.
Article in English | MEDLINE | ID: covidwho-1605167
ABSTRACT

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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Drug Treatment Type of study: Observational study / Prognostic study Limits: Humans / Male / Middle aged Language: English Journal: BMC Infect Dis Journal subject: Communicable Diseases Year: 2022 Document Type: Article Affiliation country: S12879-021-07004-8

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Drug Treatment Type of study: Observational study / Prognostic study Limits: Humans / Male / Middle aged Language: English Journal: BMC Infect Dis Journal subject: Communicable Diseases Year: 2022 Document Type: Article Affiliation country: S12879-021-07004-8