Remdesivir In Patients Research Articles

Study of Efficacy of Injection Remdesivir in Patients of COVID-19.

The coronavirus disease of 2019 (COVID-19) is a highly contagious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-COV-2). World Health Organization (WHO) declared it a pandemic on 11th March 2020. Injectable remdesivir (RDV), a repurposed antiviral, was first accorded approval by the United States of America (USA) Food and Drug Administration (FDA) on 1st May 2020, for emergency use to treat suspected or laboratory-confirmed COVID-19 patients. Interim analysis of the Solidarity trial revealed no benefits in patients treated with RDV in any group of patients with COVID-19. Here, we have attempted to place our data on the efficacy of RDV in patients of COVID-19 with moderate to severe categories. A retrospective review and data analysis of 100 COVID-19 patients with reverse transcriptase polymerase chain reaction (RT-PCR)/rapid antigen test positive was performed. Among them, 50 received RDV in addition to the standard treatment protocol (STP), while the remaining 50 received only the STP. STP is an injectable steroid and heparin, along with other supportive management. Prevalent government guidelines were followed as per usual for the classification of the patients and treatment protocol. Every day of hospitalization, the status of respiratory support was checked, and every 3rd-day inflammatory markers [C-reactive protein (CRP) and D-dimer] were measured until the patient was discharged or died. Statistical analysis of the data was done using online software. Age and comorbidity distribution in both groups ensures adequate matching between the two groups. A statistically significant difference in hospitalization days was obtained in RDV-treated patients (15 vs 19 days, p-value -0.003). Statistically significant differences were not found in mortality (6 vs 10 deaths, p-value -0.27) and reduction in oxygen (O2)/ventilatory support requirements (p-value -0.75) in the RDV group as compared to other groups. The difference in the value of CRP (p-value 0.001) and D-dimer (p-value 0.049) on day 5 is statistically significant in the RDV group as compared to the other groups. The finding of a reduction in days of hospitalization was similar to the Adaptive COVID-19 Treatment Trial (ACTT) 1 study conducted by Beigel et al. The mortality data were also comparable to those from WHO's Solidarity trial. No similarity was found in data on the reduction in ordinal scale from higher to lower scale for O2/ventilatory support on day 10 from 0. Similarity regarding the reduction in values of inflammatory markers on day 5 was found in studies conducted by Kannan et al. and Stoeckle et al. We found mortality benefit and reduction in O2 requirements/ventilatory support in RDV plus STP-administered cases as compared to STP only, but statistically, this difference is not significant, which suggests that mortality benefit in the RDV group in our study is merely by chance. Here, we can definitely conclude that days of hospital stay and inflammatory markers are reduced in the RDV plus STP-administered group, and the difference between the two groups is statistically significant, which suggests that early use of RDV could shorten the time to clinical improvement.

Effect of remdesivir on adverse kidney outcomes in hospitalized patients with COVID-19 and impaired kidney function.

Chronic kidney disease (CKD) is an important risk factor for mortality from COVID-19. Remdesivir has been shown to shorten time to recovery in patients with severe COVID-19. However, exclusion of patients with severe kidney function impairment in clinical trials has led to concerns about kidney safety of remdesivir in patients with pre-existing kidney disease. Retrospective propensity score matched cohort study of hospitalized patients with COVID-19 admitted with estimated glomerular filtration rate (eGFR) between 15 - 60 mL/min/1.73m2. Remdesivir-treated patients were 1:1 matched to historical comparators admitted during the first wave of COVID-19 (between March-April 2020) prior to emergency use authorization of remdesivir using propensity scores accounting for factors predicting treatment assignment. Dependent outcomes included in-hospital peak creatinine, incidence of doubling of creatine, rate of kidney replacement therapy initiation and eGFR among surviving patients at day 90. 175 remdesivir-treated patients were 1:1 matched to untreated historical comparators. Mean age was 74.1 (SD 12.8), 56.9% were male, 59% patients were white, and the majority (83.1%) had at least one co-morbidity. There were no statistically significant differences in peak creatinine during hospitalization (2.3mg/dL vs. 2.5 mg/dL, P = 0.34), incidence of doubling of creatinine (10.3% vs. 13.1%, P = 0.48), and rate of kidney replacement therapy initiation (4.6% vs. 6.3%, P = 0.49) in remdesivir-treated patients versus matched untreated historical comparators, respectively. Among surviving patients, there was no difference of the average eGFR at day 90 (54.7 ± 20.0 mL/min/1.73m2 for remdesivir-treated patients vs. 51.7 ± 19.5 mL/min/1.73m2 for untreated comparators, P = 0.41). Remdesivir use in patients with impaired kidney function (eGFR between 15 - 60 mL/min/1.73m2) who present to the hospital with COVID-19 is not associated with increased risk of adverse kidney outcomes.

Effects of remdesivir in patients hospitalised with COVID-19: a systematic review and individual patient data meta-analysis of randomised controlled trials

Interpretation of the evidence from randomised controlled trials (RCTs) of remdesivir in patients treated in hospital for COVID-19 is conflicting. We aimed to assess the benefits and harms of remdesivir compared with placebo or usual care in these patients, and whether treatment effects differed between prespecified patient subgroups. For this systematic review and meta-analysis, we searched PubMed, Embase, the Cochrane COVID-19 trial registry, ClinicalTrials.gov, the International Clinical Trials Registry Platform, and preprint servers from Jan 1, 2020, until April 11, 2022, for RCTs of remdesivir in adult patients hospitalised with COVID-19, and contacted the authors of eligible trials to request individual patient data. The primary outcome was all-cause mortality at day 28 after randomisation. We used multivariable hierarchical regression-adjusting for respiratory support, age, and enrollment period-to investigate effect modifiers. This study was registered with PROSPERO, CRD42021257134. Our search identified 857 records, yielding nine RCTs eligible for inclusion. Of these nine eligible RCTs, individual data were provided for eight, covering 10 480 patients hospitalised with COVID-19 (99% of such patients included in such RCTs worldwide) recruited between Feb 6, 2020, and April 1, 2021. Within 28 days of randomisation, 662 (12·5%) of 5317 patients assigned to remdesivir and 706 (14·1%) of 5005 patients assigned to no remdesivir died (adjusted odds ratio [aOR] 0·88, 95% CI 0·78-1·00, p=0·045). We found evidence for a credible subgroup effect according to respiratory support at baseline (pinteraction=0·019). Of patients who were ventilated-including those who received high-flow oxygen-253 (30·0%) of 844 patients assigned to remdesivir died compared with 241 (28·5%) of 846 patients assigned to no remdesivir (aOR 1·10 [0·88-1·38]; low-certainty evidence). Of patients who received no oxygen or low-flow oxygen, 409 (9·1%) of 4473 patients assigned to remdesivir died compared with 465 (11·2%) of 4159 patients assigned to no remdesivir (0·80 [0·70-0·93]; high-certainty evidence). No credible subgroup effect was found for time to start of remdesivir after symptom onset, age, presence of comorbidities, enrolment period, or corticosteroid use. Remdesivir did not increase the frequency of severe or serious adverse events. This individual patient data meta-analysis showed that remdesivir reduced mortality in patients hospitalised with COVID-19 who required no or conventional oxygen support, but was underpowered to evaluate patients who were ventilated when receiving remdesivir. The effect size of remdesivir in patients with more respiratory support or acquired immunity and the cost-effectiveness of remdesivir remain to be further elucidated. EU-RESPONSE.

Remdesivir saves lives. Were 3 years needed to learn that?

Remdesivir saves lives. Were 3 years needed to learn that?

Kidney Transplant Practice in Pandemic Times: Lessons Learned for the Future.

Kidney Transplant Practice in Pandemic Times: Lessons Learned for the Future.

Safety of Remdesivir in Covid Patients with Acute or Chronic Kidney Disease

Objective: The aim was to assess the safety of Remdesivir in Patients with Acute and Chronic Kidney DiseaseMethodology: Quasi-experimental study was conducted at the Pak Emirates Military Hospital Rawalpindi from March 2021 to April 2022. A sample was collected through a non-random sampling method, recruiting those who were diagnosed with pneumonia caused by the COVID-19 virus. A total of 56 patients with acute or chronic kidney disease were the participants of our study. The inclusion criterion was patient with positive COVID PCR 7-10 days prior to the commencement of the study. Patients admitted to the hospital nephrology ward with any stage of AKI were also considered for inclusion in the study. However, patients under the age of 18 and those who refused to participate were excluded.Results: The serum creatinine value were 125.15 ± 8.61 u/L and 126.44 ± 5.72 micromoles/L before and after Remdesivir use respectively. The serum ALT changed from 34.55 ± 2.69 u/L to 33.26 ± 1.85 u/L while Serum AST changed from 54.69 ± 4.04 u/L to 55.42 ± 3.09 u/L in patients with renal diseases when treated with Remdesivir for COVID-19.Conclusion: This study concluded that Remdesivir had no statistically significant effect on serum creatinine, AST and ALT. It also showed that these values showed and above normal pattern from baseline before and after the administration of Remdesivir when given in participants of the study undergoing COVID treatment with AKI or CKD.

Treatment of Severe COVID-19 Infection With Remdesivir in Peritoneal Dialysis.

End-stage kidney disease (ESKD) has been shown to be correlated with an increased risk of COVID-19 infection and mortality. Remdesivir is an effective non-EUA U.S. Food and Drug Administration (FDA)-approved antiviral agent for the treatment of COVID-19 in hospitalized adult and pediatric patients, though a lack of data has prevented its use in patients with severe kidney disease including dialysis patients. Some observational studies report the use of remdesivir in hemodialysis patients, but there are no reports of patients treated with remdesivir on peritoneal dialysis. Dialysis modalities may affect drug pharmacokinetics, and safety and efficiency of remdesivir in peritoneal dialysis is unknown. We report the first case, to our knowledge, of using remdesivir in a patient treated with peritoneal dialysis with no significant adverse events. This case illustrates the potential for remdesivir to be considered in peritoneal dialysis patients with severe COVID infection. Proper risk analysis and careful monitoring should be done, given the unpredictable clearance of the drug.

Experience of Using Remdesivir in Patients with Novel Coronavirus Infection

Timely, effective, and safe antiviral therapy in COVID-19 patients reduces complications, disability and mortality rates. The greatest concern with remdesivir is the risk of drug-induced liver injury, including in patients whose liver function is compromised by COVID-19.The aim of the study was to investigate the efficacy and safety of remdesivir in patients with confirmed SARS-CoV-2 infection who had been admitted to an infectious diseases hospital in the Volgograd region in March 2022. Materials and methods: the authors carried out an open, non-randomised, single-arm study using medical records of 234 patients who had been diagnosed with “U07.1 COVID-19, virus identified” and prescribed remdesivir upon admission. The effectiveness of therapy was evaluated using two criteria: the need for oxygen supplementation or ventilatory support, or mortality. The authors conducted the evaluation on days 7, 14, and 28 using the six-point ordinal severity scale by Y. Wang et al. The safety of therapy was assessed on the basis of complaints and changes in laboratory findings.Results: for the patients prescribed remdesivir at admission, the 7-day mortality rate was 3.0%, the 14-day mortality rate was 5.6%, and the 28-day mortality rate was 7.3%. With the exception of a patient with myocardial infarction, all the patients who had been hospitalised with mild COVID-19 and prescribed remdesivir did not require oxygen therapy and/or transfer to intensive care and were discharged following recovery. The patients with moderate to severe COVID-19 had the 14-day mortality rate of 6.4% and the 28-day mortality rate of 8.6%. 17 patients (7.2%) discontinued remdesivir prematurely for various reasons, including adverse drug reactions. Remdesivir therapy of 5-10 days was associated with an increase in ALT activity by 2.7 ± 0.8 times in 15.9% of patients with mild COVID-19, by 3.8 ± 1.8 times in 20.4% of patients with moderately severe COVID-19, and by 4.8 ± 2.7 times in 24% (12/50) of patients with severe COVID-19. In two patients (0.9%), the increase exceeded 10-fold the upper limit of normal.Conclusions: the obtained results support recommending remdesivir to patients with mild, moderate and severe COVID-19, including those with moderately elevated baseline activity of hepatic transaminases.

Effectiveness of Regdanvimab and Remdesivir in Patients with COVID-19 at a Single Hospital

Effectiveness of Regdanvimab and Remdesivir in Patients with COVID-19 at a Single Hospital

Hospital at home treatment with remdesivir for patients with COVID-19: real-life experience

ObjectivesAccess and appropriateness of therapeutics for COVID-19 vary because of access or regulatory barriers, the severity of the disease, and for some therapies, the stage of the pandemic and circulating variants. Remdesivir has shown benefits in clinical recovery and is the treatment of choice for selected patients, both hospitalized and nonhospitalized, in main international guidelines. The use of remdesivir in alternatives to conventional hospitalization such as hospital at home (HaH) units remains incompletely explored. In this study, we aim to describe the real-life experience of outpatient remdesivir infusion for COVID-19 in a HaH unit. MethodsWe selected all the consecutive patients receiving remdesivir from a prospective cohort of 507 COVID-19 patients admitted at a HaH unit. Admission criteria included COVID-19 with a fraction of inspired oxygen requirement under 0.35 and respiratory rate under 22 rpm. Patients were daily assessed in person by a nurse and a physician. ResultsA total of 236 patients admitted at the HaH unit received remdesivir, 172 of whom were treated at home. Only 2% presented any adverse event related to the infusion, all of them mild. HaH saved 1416 day-beds, with only 5% of the patients requiring transfer back to the hospital. ConclusionRemdesivir infusion in HaH units seems to be a safe and efficient alternative to conventional hospitalization for treating patients with nonsevere COVID-19.

Use of remdesivir for COVID-19 in patients with hematologic cancer.

Patients with hematologic malignancies (HM) are among the individuals with highest risk of COVID-19 complications. We report the impact of remdesivir in patients with hematologic malignancies (HM) during Omicronin Mexico City. All patients with HM and COVID-19 during December 2021-March 2022 were included. Socio-demographic and clinical data were collected. The primary outcome was COVID-19 progression. Variables associated with progression were analyzed. 115 patients were included. Median age was 50years (IQR 35-63); 36% (N = 41) had at least one comorbidity. Fifty-two percent had non-Hodgkin lymphoma. Fifty patients (44%) had at least two doses of SARS-CoV-2 vaccine. COVID-19 was classified as mild (52.6%), moderate (9.7%), and severe/critical (28%). Twenty-eight patients (24%) received remdesivir. Nine patients received remdesivir at the ambulatory clinic (33%), the rest during hospital admission. Overall, 22(19%) patients progressed to severe/critical COVID-19; nine died due to COVID-19(8%). Hospital admission for non-COVID-19 causes was associated with higher odds of progression. Remdesivir did not reduce the risk of progression in hospitalized patients; none of the patients who received remdesivir in the ambulatory clinic progressed to severe COVID-19 or died. Patients with HM and COVID-19 continue to present with high risk of complications. More prospective studies are needed to define the impact of antivirals in this high-risk group, including the best duration of treatment. Also, better vaccine coverage and access to treatment are mandatory.

Medical and chemical efficacy of respiratory physiotherapy and Remdesivir in patients with COVID-19 pneumonia: A systematic review and meta-analysis

"Evaluated efficacy of Respiratory Physiotherapy and Remdesivir on patients with COVID-19 pneumonia. In current systematic review and meta-analysis study, articles published January 2019 to December 1, 2021 were reviewed in the databases of PubMed, Scopus, Web of Science, and EBSCO. Risk ratio and mean differences with 95% confidence interval (CI), fixed effect model and Mantel–Haenszel or Inverse-variance formula were calculated. The Meta analysis have been evaluated with the statistical software Stata/MP v.16 (The fastest version of Stata). Mean differences of PaO2/FiO2 ratio at 6h after chest Respiratory Physiotherapy was (MD, 66 mmHg 95 % CI 64.71 mmHg, 67.28 mmHg; p=0.0007). Risk ratio of recovery rate between experimental and control group was 0.20 (RR, 0.20 95 % CI 0.15, 0.25) with high heterogeneity (I2 =78.84%; p=0.00). Risk ratio of mortality rate between experimental and control group was -0.34 (RR, -0.34 95 % CI -0.65, - 0.03) with low heterogeneity (I2<0%; p=0.51). Based on the findings of meta-analysis, Respiratory Physiotherapy can play an effective role in respiratory therapy and rehabilitation of patients admitted to the ICU with COVID-19. A meta-analysis showed that treatment with Remdesivir could increase the recovery rate, especially in the early days of COVID-19; also reduces the mortality rate."

47D11 Antibody-Engineered Exosomes for Targeted Delivery of Remdesivir in Patients with COVID-19: Dream or Principle? (A Critical Editorial Study).

Along with the high transmission rate of coronavirus disease 2019 infection in the last few months, the morbidity and mortality rate of coronavirus disease 2019 has been increased among critically-ill patients, especially the elderly or the ones with immunodeficiencies. So, there is an urgent need to develop more effective therapeutic agents through immunopathophysiological and immunotherapeutic-based strategies for these patients. Here, we hypothesize that mixing S1b-RBD-expressing mesenchymal stem cell-derived exosomes (which have been previously enriched with Remdesivir) with 47D11 antibody, can promisingly guarantee effective transferring of those targeted exosomes to the targeted microenvironment of coronavirus disease 2019 infection. In addition, it can induce their immunomodulatory properties, and anti-viral features, refraining from entrance of severe acute respiratory syndrome-related coronavirus-2 to angiotensin-converting enzyme 2-expressing cells.

Evaluation of the efficacy and safety of remdesivir in hospitalized patients with a new coronavirus infection COVID-19: data from a Russian university clinic

Introduction. The use of remdesivir in patients with the new coronavirus infection COVID-19 is known to improve the prognosis of the disease. But there is not enough data on efficacy and safety of remdesivir use in patients from Russia. Aim. To evaluate the efficacy and safety of remdesivir in patients with COVID-19. Materials and methods. A comparative prospective study was conducted in two parallel groups. The study enrolled 300 patients diagnosed with COVID-19 (grade 1–3 severe pneumonia according to CT scan), who were divided into two groups (n = 150 in each) according to the prescription of remdesivir. Treatment efficacy was assessed by recording cases of disease progression and adverse outcomes. The safety of therapy was assessed by hepatotoxicity and nephrotoxicity. Results. Patients receiving remdesivir were significantly less likely to be transferred to the intensive care unit (OR 0.3884, 95% CI: 0.1645–0.9175) and to be on artificial ventilation (OR 0.3830, 95% CI: 0.1539–0.9527). Treatment with remdesivir had no significant effect on mortality (OR 0.4932, 95% CI: 0.08897–2.7346) and complications (OR 0.4391, 95% CI: 0.1623–1.1879), including acute respiratory distress syndrome (OR 0.3919, 95% CI: 0.07483–2.0524). The duration of hospitalization was significantly shorter in group 1 patients – 12.2533 days (95% CI: 11.4101–13.0966) compared to group 2 – 14.5267 days (95% CI: 13.5125–15.5408). Hepatotoxicity with remdesivir (OR 1.5376, 95% CI: 0.8035–2.9426), nephrotoxicity (OR 1.6338, 95% CI: 0.522–5.1141) were noted, but no statistically significant difference was found (p > 0.05). Conclusions. The addition of remdesivir to the basic regimen of patients with new coronavirus infection COVID-19 improved the course of the disease, reducing the risks of patients being transferred to the intensive care unit and of receiving artificial ventilation.

Early Outpatient Treatment With Remdesivir in Patients at High Risk for Severe COVID-19: A Prospective Cohort Study.

BackgroundEarly treatment of coronavirus disease 2019 (COVID-19) with remdesivir in high-risk patients, including those with immunosuppression of different causes, has not been evaluated. The objective of this study was to assess the clinical effectiveness of early remdesivir treatment among patients with mild to moderate COVID-19 at high risk of progression.MethodsThis prospective cohort comparative study was conducted in a tertiary referral center in Mexico City. Patients with mild to moderate COVID-19 at high risk for progression were treated with an ambulatory 3-day course of remdesivir. The primary efficacy composite outcome was hospitalization or death at 28 days after symptom onset. A Cox proportional hazards regression model was used to identify associations with the primary outcome.ResultsFrom December 1, 2021, to April 30, 2022, a total of 196 high-risk patients were diagnosed with COVID-19, of whom 126 were included in this study (43%, 54/126, received remdesivir; 57%, 72/126, did not receive remdesivir). Baseline clinical characteristics were similar between groups; autoimmune diseases (39/126), solid organ transplant (31/126), and malignant neoplasms (24/126) were the most common immunocompromising conditions. Diabetes mellitus was strongly associated with the primary outcome in both groups. Prior severe acute respiratory syndrome coronavirus 2 infection or vaccination was not independently associated with COVID-19 progression. Treatment with remdesivir significantly reduced the odds of hospitalization or death (adjusted hazard ratio, 0.16; 95% CI, 0.06–0.44; P < .01).ConclusionsEarly outpatient treatment with remdesivir significantly reduces hospitalization or death by 84% in high-risk, majority immunosuppressed patients with Omicron variant COVID-19.

Remdesivir Administration in COVID-19 Patients With Renal Impairment: A Systematic Review.

Remdesivir (RDV) is the main antiviral for the treatment of moderate to severe forms of Coronavirus disease 2019 (COVID-19). Several studies revealed a shortening time to clinical improvement of COVID-19 and mortality benefits in patients receiving RDV. The patients with renal disease were excluded from large clinical trials of RDV, and the probable nephrotoxicity of the drug, its metabolites, and the vehicle (sulfobutylether-β-cyclodextrin) have led to the recommendation against using RDV in patients with an estimated glomerular filtration rate of <30 mL/min. This systematic review aimed to collect data about the necessity and safety administration of RDV in the setting of renal impairment. Search through databases including MEDLINE, ScienceDirect, Cochrane Library, and PubMed was performed. The studies were carried out in adults and enrolled patients with different types of renal impairment (ie, acute kidney injury, chronic kidney disease, kidney transplant, and renal replacement therapy) were included. Eligible studies were assessed, and required data were extracted. Twenty-two cross-sectional studies, cohorts, case reports, and case series were included in this review. The mortality rate was between 7.3% and 50%, and various severity of COVID-19 was included in the studies. None of them reported an increase in adverse effects attributed to RDV administration. A decrease in inflammatory mediators and other benefits were obvious. Although the manufacturer's labeling does not recommend RDV administration in patients with severe renal impairment, it seems that nephrotoxicity is less concerning in the population of these patients. Moreover, RDV may be helpful in acute kidney injury induced by the viral invasion of COVID-19. To the best of our knowledge, this is the first systematic review of the use of RDV in kidney failure. Larger, well-designed, and pharmacokinetic studies are required to have a safe and logical recommendation about the use of RDV in patients with renal disorders.

AN EVALUATION OF ADVERSE DRUG REACTIONS WITH REMDESIVIR IN PATIENTS OF COVID-19

Objectives: The aim of the study was to evaluate the adverse drug reactions (ADR) following Remdesivir therapy in patients of COVID-19. Methods: All patients more than 18 years of age of any gender, diagnosed with COVID-19 infection receiving remdesivir therapy and fulfilling the selection criteria were included in the study after informed consent. They were monitored for ADRs till end of treatment and analyzed for characteristics of the ADRs: Causality, severity, and preventability. Results: Out of 80 patients (mean age of 49.27±16.22 years) enrolled, 51 (63.75%) developed 84 ADRs. Most common ADRs included increased aspartate transaminases, (20.23%), increased bilirubin (19.04%), increased alanine transaminases (13.09%), increased creatinine (11.90%), and increased blood urea (9.52%). Causality assessment using WHO-UMC scale showed, 85.71% possible, 13.09% probable, and 1% certain causal association of the ADRs with remdesivir. A total 75% ADRs were mild in severity and 45% patients recovered from the event at the end of treatment. Conclusion: Hepatic and Renal dysfunctions are observed with remdesivir in COVID-19 patients. Intensive monitoring of ADRs with newer drugs with EUA such as remdesivir is warranted to ensure safer use in patients.

A Retrospective Study of Dexamethasone, Remdesivir, and Baricitinib in Severe COVID-19.

Purpose RECOVERY, ACTT-1, and ACTT-2 trials have demonstrated that utilization of dexamethasone, remdesivir, or a combination of remdesivir with baricitinib leads to mortality benefit and faster time to recovery, respectively. However, no studies have investigated the benefit of triple therapy of dexamethasone, remdesivir, and baricitinib. We investigate the benefits of triple therapy compared to dual therapy of dexamethasone with remdesivir in patients with severe COVID-19 on HFNC. Materials and Methods A retrospective data analysis was performed on patients with severe COVID-19 requiring HFNC and evaluated for hospital discharge status, requirement of mechanical ventilation, length of stay, and days on HFNC. Results Among 191 patients with severe COVID-19, 81 patients received dexamethasone, remdesivir, and baricitinib. Patients receiving triple therapy had a significant survival benefit (HR 0.52; P=0.042). Treatment with triple therapy vs. dual therapy also trended towards less requirement of mechanical ventilation (OR 0.66; P=0.26). There was no significant change in length of stay (mean 13.74 vs. 13.31; P=0.74) or days on HFNC (mean 8.95 vs. 7.28 days, P=0.16). Conclusions The use of dexamethasone, remdesivir, and baricitinib in patients with severe COVID-19 requiring HFNC was associated with a significant survival benefit in comparison to dual therapy of dexamethasone with remdesivir.

Remdesivir for patients with Coronavirus disease 2019 pneumonia requiring high oxygen support.

Background: Treatment options for patients with critical Coronavirus Disease 2019 (COVID-19) are limited. This study aimed to describe the clinical characteristics and outcomes associated with remdesivir therapy in patients with COVID-19 who require non-invasive (NIV) ventilation or invasive mechanical ventilation (IMV).Methods: Data were retrospectively extracted for adults with COVID-19 confirmed using polymerase chain reaction (PCR) between August 1, 2020 and January 28, 2021 who received ≥ 48 hours of remdesivir therapy while on NIV or IMV. Clinical improvement was defined as two-category improvement on an eight-point ordinal severity scale.Results: A total of 133 individuals were included, of which 114 (85.7%) were on NIV and 19 (14.3%) were on IMV at the time of remdesivir initiation. The majority of the patients were males (62.4%), and the median age was 56 years. All the patients received concomitant dexamethasone therapy. Remdesivir treatment was commenced after a median of 7 days from onset of symptoms and was continued for a median of 5 days.Clinical improvement within 28 days was achieved in 101 patients (75.9%); among which, 78.1% and 63.2% were subjected to baseline NIV and IMV, respectively. Among the 11 (8.3%) patients who died of any cause by day 28, 9 (7.9%) and 2 (10.5%) were subjected to baseline NIV and IMV, respectively. The most frequent adverse events were sinus bradycardia (21, 13.1%) and alanine transaminase increase (18, 11.3%). Almost all adverse events were classified as Grades 1–3.Conclusion: The use of remdesivir in combination with systemic corticosteroids is associated with high recovery rates and low all-cause mortality in patients with COVID-19 pneumonia who require NIV or IMV. The results need confirmation from clinical trials of appropriate design and size.

Safety and Tolerability of Remdesivir in Patients with End-stage Renal Disease on Maintenance Hemodialysis.

IntroductionThe use of remdesivir is not recommended in patients with end-stage renal disease (ESRD) with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection unless potential advantage offset disadvantage due to limited safety data. Our objective was to assess the safety of remdesivir in patients with end-stage renal failure and evaluate the outcome of this vulnerable group.MethodologyWe carried out a retrospective observational study in dialysis-dependent ESRD patients with SARS-CoV-2 infection who received a standard 5-day course of remdesivir (powder form) from June 2020 to December 2020. Oxygen requirement, hemogram, inflammatory markers, and liver function tests before and after remdesivir treatment were compared.ResultWe found thirty-nine such patients with mean age of patients 58.79 ± 12.13 years. Diabetes mellitus, hypertension, and cardiac diseases were present in 58.97, 87.17, and 23.07% of patients, respectively. Mean oxygen saturation on admission was 85.41% (±7.73). There were no events of hepatotoxicity, altered behavior, or infusion reaction. There was statistically significant improvement in total leukocyte count, absolute lymphocyte counts, and C-reactive protein (p value <0.001, 0.01, and 0.02, respectively) post remdesivir treatment. A total of 60% of patients had improved oxygenation while 13% of patients had no change in oxygen requirement after completion of remdesivir course. Mortality in our study was 28.21%. We did not find any significant benefit of early remdesivir administration (3–6 days of illness) on mortality or days of hospitalization.ConclusionThe use of remdesivir in end-stage kidney disease is safe. Improvement in oxygenation was significant when baseline oxygen requirement was less. It requires prospective controlled trials with larger population to assess its impact on mortality.How to cite this articleShah MK, Parikh M, Prajapati D, Kute VB, Bhende P, Prajapati A, et al. Safety and Tolerability of Remdesivir in Patients with End-stage Renal Disease on Maintenance Hemodialysis. Indian J Crit Care Med 2022;26(5):619–625.