A retrospective analysis to study the Effectiveness and Safety profile of Remdesivir therapy in patients who diagnosed with COVID-19

Not yet recruiting

Conditions: Coronavirus as the cause of diseases classified elsewhere,

Registration Number: CTRI/2021/01/030433

Lead Sponsor: Dr Vishal Shanbhag

Brief Summary: Remdesivir is widely used among COVID-19 patients except for those patients with an estimated glomerular filtration rate of less than 30 mL/min. RCTs are evident on the effectiveness of remdesivir compared to placebo with respect to the shorter time to clinical improvement and duration of mechanical ventilation among those who are initiated with the treatment with 10 days of symptom onset, though it is not statistically significant. Moreover, observational studies reported that remdesivir was effective in improvement in chest CT scan, oxygen saturation, need for oxygenation, and discharge rate. Another RCT is evident for the better effectiveness of remdesivir than placebo in terms of recovery rate, recovery time with a better safety profile. However, no studies have been investigated the time of onset or initiation of remdesivir therapy in COVID-19. Hence we aimed to analyze the effectiveness and of early or late remdesivir therapy among the COVID-19 patients.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 1050

Inclusion Criteria

All adults patients diagnosed with laboratory-confirmed SARS-CoV-2 infection from March 2020 to September 2020 in Kasturba Hospital Manipal irrespective of gender will be included.

Exclusion Criteria

Pediatric population.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality rate/death, Reversal of COVID-19/recovery, Duration of ICU or ventilation and/or Hospital stay, Negative RT-PCR, Improvement in Chest CT, Radiological parameters by CXR Brixia Score, and Lung Zone wise Brixia Score distribution	The outcomes will be measured at baseline, at 24 hours, 48 hours, 72 hours, and 5days post administration of remdesivir

Secondary Outcome Measures

Name	Time	Method
Safety measures such as Adverse events, Serious adverse events, Adverse drug reaction and Treatment discontinuation	The outcomes will be measured or monitored at baseline, at 24 hours, 48 hours, 72 hours, and 5days post administration of remdesivir

Trial Locations

Locations (1): Kasturba Medical College and Hospital
🇮🇳
Udupi, KARNATAKA, India
Kasturba Medical College and Hospital
🇮🇳Udupi, KARNATAKA, India
Dr Vishal Shanbhag
Principal investigator
9901960496
vishal.shanbhag@manipal.edu