Abstract

The ACTT-1 study found a significant benefit in time to recovery evaluating the use of Remdesivir in COVID-19. However, it excluded patients with stage 4 CKD or those requiring dialysis.Through this small study, we report our findings of Remdesivir therapy in patients with AKI or CKD at baseline or after starting therapy. Aim: 1. To study the effect of Remdesivir therapy on renal and hepatic function in COVID-19 patients with renal dysfunction at baseline or after starting therapy. 2. To identify factors, if any, related to efficacy of Remdesivir therapy on patient outcome. Design: A prospective observational study conducted from 30th July to 7th November, 2020. Inclusion Criteria: Patients meeting all the below criteria irrespective of baseline GFR (including those already on Maintenance Hemodialysis) or baseline deranged LFT. 1. Age >18yrs. 2. COVID-19 RT-PCR positive. 3. Meeting criteria for administration of Remdesivir-(any one of the following) a.COVID-19 pneumonia with RR >30/min or SP02 <94% on room air. b.ARDS. 4. Renal dysfunction at baseline,during or within 48hrs of completion of therapy. Dose: eGFR >30ml/min or on dialysis- 200mg on day1, followed by 100mg per day for 4 days. eGFR <30ml/min,but not on dialysis- 200mg on day 1, followed by 100mg alternate day for 4 doses. 34 patients had renal dysfunction at baseline or developed it after Remdesivir therapy-16 were AKI, 10 CKD, 4 CKD5D and 4 were post renal transplant. Mean age was 58.65±12.59 yrs (27-90 yrs.) with 23 (67.6 %) Males. Before therapy, ARDS severity was Mild-4 (11.76%), Moderate-14 (41.17%) and severe-16 (47.05%) with 11 (32.35%) on BMV,13 (38.23%) on CPAP and 10 (29.41%) on Invasive ventilation. Mean duration of symptom onset before starting therapy was 6.79±2.23 days (1-12 days). Mean follow up period was 15.6 days (3-42 days). Overall mortality was 18/34 (52.9%). Renal Outcome: 4 were already on HD before therapy (all were CKD5D). 8/30(26.66%) needed HD during or after therapy-15 expired and among 15 survivors, 14 returned to their baseline renal function after cessation of therapy, 01 is still dialysis dependent.View Large Image Figure ViewerDownload Hi-res image Download (PPT)In the dialysis dependent CKD (n=4) subgroup, 3 expired and 01 was discharged. In the post Renal transplant (n=4) group, all developed AKI during or after completion of therapy. None required HD, 2 returned to their baseline renal function, 2 expired. Hepatic Outcome: Only 5 had ALT elevation(x1 ULN) during or within 48 hrs of completion of therapy-3 expired, 2 returned to baseline.View Large Image Figure ViewerDownload Hi-res image Download (PPT)Lower PaO2/FiO2 (severe ARDS) (p=0.0001), higher CRP (p=0.022), higher serum LDH (p=0.038) and duration of symptoms before starting therapy (p=0.05) were statistically significant variables at baseline associated with higher mortality. Overall Mortality was 52.9% (18/34), with non survivors having statistically significant poor prognostic indicators: severe ARDS, higher inflammatory markers & duration of symptoms before therapy. All AKI survivors showed complete recovery of renal function. All except one AKI on CKD survivors showed return of serum creatinine to baseline. Only 5 patients developed mild hepatic dysfunction. Remdesivir may be tried in patients with renal dysfunction at baseline or during therapy if the benefits outweigh the risks.However larger, well-controlled studies evaluating its safety and efficacy in patients with AKI and CKD is needed.

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