An official website of the United States government
Here's how you know
Official websites use .gov
A
.gov website belongs to an official
government organization in the United States.
Secure .gov websites use HTTPS
A lock (
) or https:// means you've safely
connected to the .gov website. Share sensitive
information only on official, secure websites.
As a library, NLM provides access to scientific literature. Inclusion in an NLM database does not imply endorsement of, or agreement with,
the contents by NLM or the National Institutes of Health.
Learn more:
PMC Disclaimer
|
PMC Copyright Notice
Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
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.
Methods
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.
Results
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.
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.
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.
Conclusions
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.
