Personal Medication List Template La Care

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Personal Medication List Template La Care

Personal Medication List Template La Care

Remdesivir Plus Usual Care Versus Usual Care Alone for the Treatment of Patients with COVID-19 (DisCoVery): A Phase 3, Randomized, Controlled, Open-Label Trial

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The antiviral efficacy of remdesivir against SARS-CoV-2 remains controversial. We sought to assess the clinical effectiveness of remdesivir plus standard care versus treatment alone in patients hospitalized with COVID-19 on oxygen or respiratory support.

DisCoVery was a phase 3, open-label, adaptive, multicenter, randomized and controlled trial conducted at 48 sites in Europe (France, Belgium, Austria, Portugal, Luxembourg). Adult patients (age ≥ 18 years) hospitalized with laboratory-confirmed SARS-CoV-2 infection and disease of any duration were eligible if they had clinical evidence of hypoxemic pneumonia or had need supplemental oxygen. Exclusion criteria were elevated liver enzyme values, severe chronic kidney disease, any contraindication to any of the study treatments or their use 29 days prior to randomization or use of ribavirin, and pregnancy or breastfeeding. Participants were randomly assigned (1:1:1:1:1) to receive standard care alone or in combination with remdesivir, lopinavir-ritonavir, lopinavir-ritonavir and interferon beta-1a or hydroxychloroquine. Randomization used computer-generated blocks of varying sizes; it was divided by the severity of the disease at the time of inclusion and the European administrative area. Remdesivir was given as a 200 mg intravenous infusion on day 1, followed by daily one-hour infusions of 100 mg until day 9 for a total of 10 days. It can be stopped after 5 days if the participant has been released. The primary outcome was clinical status at day 15 as measured by the WHO seven-point ordinal scale, assessed by intention to treat. Safety was assessed by modified intention to treat in the population and was one of the secondary outcomes. This study is registered in the European Clinical Trials Database, EudraCT2020-000936-23, and ClinicalTrials.gov, NCT04315948.

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Between March 22, 2020 and January 21, 2021, 857 participants were recruited and randomized to receive remdesivir plus standard care (n=429) or standard care only (n=428). Fifteen participants from the remdesivir group and ten participants from the control group were excluded from the analysis. On day 15, the WHO ordinal scale distribution was: (1) no hospitalization, no activity limitation (61 [15%] of 414 in the remdesivir group

24 [6%)]. The difference between treatment groups was not significant (odds ratio 0.98 [95% CI 0.77–1.25]; p=0.85). There was no significant difference in the incidence of serious adverse events between treatment groups (remdesivir, 135 [33%] of 406

Control, 130 [31%] of 418; p = 0.48). Researchers attributed three deaths (acute respiratory distress syndrome, bacterial infection, and hepatorenal syndrome) to remdesivir, but only one (hepatorenal syndrome) was attributed by the sponsor’s safety team.

Personal Medication List Template La Care

No clinical benefit was observed with remdesivir in patients hospitalized with COVID-19, asymptomatic for more than 7 days and requiring oxygen support.

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Commission of the European Union, French Ministry of Health, Area of ​​major interest One Health Île-de-France, REACTing, Fund Erasmus-COVID-Free University of Brussels, Belgian Center for Expertise in Health Care, Austrian Group Medical Tumour, European Regional Development Fund, Portuguese Ministry of Health, Portuguese Innovation Agency for Clinical Research and Biomedicine.

We searched Medline using the terms MESH on 22 July 2021 for randomized controlled trials using the terms (“remdesivir” OR “remdesivir triphosphate” OR “GS-441524”) AND (“SARS-CoV-2” OR “COVID- 19”) AND (“Randomized Controlled Trial”) for clinical trials evaluating the efficacy of remdesivir in hospitalized patients with COVID-19 without language restrictions. Our search found ten articles, only four of which compared remdesivir to placebo (n=2) or treatment (n=2). Two of these studies reported a faster recovery time in patients treated with remdesivir, although no difference in mortality was observed overall. In two studies comparing remdesivir with placebo, the incidence of adverse events was similar in the remdesivir and placebo groups.

DisCoVery is a multicenter, open-label, randomized, controlled trial reassessing the safety and efficacy of drugs intended for use in the clinical condition of hospitalized adult patients with COVID-19. We found no significant differences in clinical status at days 15 and 29, time to hospital discharge, all-cause mortality at 28 days, or SARS-CoV-2 viral kinetics in patients receiving usual care alone versus standard care and remdesivir. . No significant difference was observed in the occurrence of serious adverse events between the groups.

A faster recovery time than previously reported was not observed in the DisCoVery trial. Consistent with previous evidence, the results of the DisCoVery study do not support the use of remdesivir in hospitalized patients with COVID-19 in the population with symptoms for more than a week and requiring oxygen support.

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Drugs for reactivation of SARS-CoV-2-related COVID-19 have been evaluated in several large-scale randomized clinical trials. Of these, the DisCoVeRy study examined the efficacy and safety of lopinavir-ritonavir, lopinavir-ritonavir, interferon beta-1a, hydroxychloroquine and remdesivir compared to standard treatment in adults hospitalized with COVID-19.

DisCoVery Trial Protocol: A Multicenter, Adaptive, Randomized Trial Investigating the Safety and Effectiveness of Treatments for COVID-19 in Hospitalized Adults.

An open label randomized controlled trial of lopinavir/ritonavir, lopinavir/ritonavir plus IFN-β-1a and hydroxychloroquine in hospitalized patients with COVID-19.

Personal Medication List Template La Care

Remdesivir is a small molecule formulated with sodium sulfobutyl ether B-cyclodextrin for injection, is dialysable, known to penetrate deep compartments well, and does not have CYP450-mediated drug interactions.

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Remdesivir is a nucleotide analog prodrug that is metabolized intracellularly to an ATP analog that inhibits RNA polymerase activity in certain pathogenic coronaviruses.

Remdesivir has demonstrated antiviral activity against SARS-CoV-2 in preclinical models both in vitro and in vivo,

To support its COVID-19 assessment. In a randomized, double-blind clinical trial in China involving 237 patients with COVID-19, remdesivir was associated with a shorter time to clinical improvement in patients who started treatment within 10 days of onset. symptoms.

In the Covid-19 Adaptive Treatment Trial (ACTT 1) of 1062 patients, remdesivir was associated with a shorter recovery time (10 days

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Accordingly, an emergency use permit. Similarly, a WHO-sponsored International Solidarity Consortium study of 2,750 remdesivir patients found no benefit of remdesivir on in-hospital mortality across different healthcare settings.

Overall, these mixed results have so far not led to a consensus on the use of remdesivir in patients with COVID-19.

In another study, DisCoVeRy shared baseline patient characteristics with the WHO Solidarity Consortium, along with hospital discharge dates and potential need for oxygen therapy, a standard device. , high-flow machine, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) or death.

Personal Medication List Template La Care

Of the 2750 participants randomized to remdesivir in the Solidarity trial, 219 (8.0%) and 221 (5.4%) of the 4088 randomized to standard care were allocated to the DisCoVery trial. Designed to further document clinical outcomes, virologic kinetics, treatment pharmacokinetics, and associated safety data, DisCoVeRy reports preliminary analyzes of remdesivir versus the control.

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DisCoVery is a Phase 3, open-label, adaptive, multi-center, randomized, controlled trial to reassess the efficacy and safety of relabeled drugs in adults hospitalized with COVID-19.

The experiment was carried out in 48 localities in France (39 plants), Belgium (3), Austria (3), Portugal (2) and Luxembourg (1). The trial was approved by the ethics committee (CPP Ile-de-France-III, accreditation #20.03.06.51744), sponsored by the National Institute of Health and Medical Research (INSERM, France), and conducted in accordance with the Declaration of Helsinki. This analysis is based on version 11.0 of the protocol published on 12/12/2020.

Patients over the age of 18 who were hospitalized with laboratory-detected SARS-CoV-2 infection and regardless of disease duration were eligible if they had at least one of the following: assessment clinical (evidence of rales or crackles on examination) and oxygen saturation (SpO

) 94% or less in ambient air; or supplemental oxygen, high flow oxygen devices, noninvasive ventilation, or mechanical ventilation. Participants of childbearing age agreed to use at least one primary method of contraception for the duration of the study. Participants were excluded if they had liver enzymes (alanine aminotransferase or aspartate aminotransferase) more than five times the upper limit of normal, had severe stage 4 chronic kidney disease, or required dialysis (estimated glomerular filtration rate lower at 30 mL/min), or had a planned transplant within 72 hours to another hospital that was not a study site. Participants were also excluded if they were pregnant or breastfeeding, if they had a contraindication to a study drug, including an allergy, if they had been treated with any of the antiviral drugs evaluated in the course of the last 29 days,

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