safety of remdesivir use in patients with impaired kidney function and covid 19 infection

Not yet recruiting

Conditions: Acute kidney failure, unspecified, (2) ICD-10 Condition: N189||Chronic kidney disease, unspecified, (3) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,

Registration Number: CTRI/2020/12/030046

Lead Sponsor: DrMaulin Shah

Brief Summary: COVID-19,caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), hasled to more than 50 million of infections and over 1 million deaths worldwide.Given the current, ongoing pandemic of COVID-19, there is a need to identifysafe and effective treatment options among so many available drugs. Remdesivir (GS-5734), a prodrug ofadenosine analogues, has been shown to have antiviral activity against severalRNA viruses, including MERS-CoV ,Ebola virus and SARS-CoV-2..On May1, 2020, after review of unpublished data from available clinical trials, theUS Food and Drug Administration (US FDA) issued an emergency use authorization (EUA)to permit the use of remdesivir, a nucleotide analogue that inhibits viralRNA-dependent RNA polymerase (RDRP), for treatment of severe coronavirus disease 2019 (COVID-19). Lateron October 22, 2020, FDA approved its use in adults andpediatric patients (12 years of age and older and weighing at least 40 kg) forthe treatment of COVID-19 requiring hospitalization.1Notably, patients with severe AKI and ESKD were excluded from this and allother remdesivir trials on the basis of eGFR cut-offs (either 50 or 30 ml/minper 1.73m2). Hence it isnot recommended in the group of patients where it required most just because oflack of data. But preliminary report suggests its use in these group ofpatients without its adverse effect on renal function.3. Based onthese data it has been used in these group of patients in our hospital as wellas all tertiary covid designated facilities after taking informed writtenconsent from patientsâ€™ relative as there is no other suitable alternativeexist. We want to analyse retrospectively its safety in these patients.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

All covid positive (Rapid antigen test or RT PCR) patients admitted in shree Krishna hospital from March 2020 whose presenting creatinine is more than 1.4 mg/dl in Male or 1.2 mg/dl in Female or who are having oliguria /anuria (urine output less than 0.5 ml/kg/hour in first 24 hours -as per Standard KDIGO criteria) and who also received Remdesivir short or prolonged course during hospital stay will be included.

Exclusion Criteria

Those Covid positive patients with renal dysfunction will be excluded from study if they do not complete the course of remdesevir suggested by clinician.
However, those patients who expired during treatment of remdesivir will be included in study and they will be analyzed separately.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Remdesevir is safe in patients with acute or chronic kidney injury and covid 19 infection	4 weeks

Secondary Outcome Measures

Name	Time	Method
reduction in hospital stay and mortality in chronic kidney disease patients infected with covid 19 infection and severe lung involvement treated with remdesevir	8 weeks

Trial Locations

Locations (1): Pramukhswami medical college
🇮🇳
Anand, GUJARAT, India
Pramukhswami medical college
🇮🇳Anand, GUJARAT, India
DrMaulin Shah
Principal investigator
9904163277
mauls39@gmail.com