Remdesivir Is the First FDA-Approved Treatment for COVID-19

On Oct. 22, the Food and Drug Administration (FDA) approved the first drug for treating COVID-19. Remdesivir, an antiviral medication given intravenously, is now approved for anyone hospitalized with COVID-19. It works by blocking the virus’s ability to make more copies of itself. Earlier this year, the drug had received emergency use authorization (EUA), which falls short of approval but is granted during a public health crisis if there is encouraging data supporting its potential benefits. Approval means the drug’s maker, Gilead, provided more information to the FDA on the medication’s effectiveness and safety than was used to issue the EUA. “This decision by the FDA is a milestone in the treatment of hospitalized patients with COVID-19,” says Dr. Andre Kalil, professor of internal medicine at University of Nebraska Medical Center who was among the first to treat patients from the Diamond Princess Cruise ship with remdesivir and runs one of the drug’s clinical trials. “Remdesivir shortens the recovery time by 5-7 days, provides 50% faster clinical improvement, prevents patients’ progression to mechanical ventilation, and is associated with a 45% mortality reduction in the first two weeks of disease. These are real and meaningful benefits to our patients.” The FDA decision is based on three randomized controlled trials that found that people receiving remdesivir shortened their recovery time. While the data did not find ...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 Source Type: news

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New U.S. Food and Drug Administration (FDA) guidance means a COVID-19 vaccine likely will not be approved by Election Day—which could actually be a good thing for public health. On Oct. 6, the agency posted an industry guidance document on its website asking pharmaceutical companies applying for emergency-use authorization of a COVID-19 vaccine to monitor study subjects for at least two months after vaccination, so they can look for side effects that may arise over time and get a better sense of the shot’s efficacy. That means it’s unlikely any manufacturer will receive authorization before Election Day o...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 Source Type: news
CONCLUSION Pediatric patients with SARS–CoV-2 are at risk for critical illness with severe COVID-19 and MIS-C. Cytokine profiling and examination of peripheral blood smears may distinguish between patients with MIS-C and those with severe COVID-19.FUNDING Financial support for this project was provided by CHOP Frontiers Program Immune Dysregulation Team; National Institute of Allergy and Infectious Diseases; National Cancer Institute; the Leukemia and Lymphoma Society; Cookies for Kids Cancer; Alex’s Lemonade Stand Foundation for Childhood Cancer; Children’s Oncology Group; Stand UP 2 Cancer; Team Connor;...
Source: Journal of Clinical Investigation - Category: Biomedical Science Authors: Source Type: research
AbstractThe coronavirus disease (COVID-19) is caused by Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and presents with respiratory symptoms which can be life threatening in severe cases. At the start of the pandemic, allergy, asthma, and chronic obstructive pulmonary disease (COPD) were considered as risk factors for COVID-19 as they tend to exacerbate during respiratory viral infections. Recent literature has not shown that airway allergic diseases is a high-risk factor or that it increases the severity of COVID-19. This is due to a decrease in Angiotensin-converting enzyme 2 (ACE2) gene expression in the ...
Source: European Archives of Oto-Rhino-Laryngology - Category: ENT & OMF Source Type: research
The COVID-19 pandemic has had a worldwide effect for what seems like an eternity. After shelter-in-place orders became more prevalent in March,  most people probably didn’t think they’d still be wearing masks in October. So the question remains, when will the pandemic end?  It turns out there are quite a few factors that contribute to the rise and fall of a pandemic, some within our control, some that are not. An outbreak becomes a pandemic when it meets two criteria, first, it spreads rapidly and widely, and second, it must qualify as a severe disease. If either of these factors change, it is no long...
Source: Conversations with Dr Greene - Category: Child Development Authors: Tags: Dr. Greene's Blog Coronavirus COVID COVID-19 COVID-19 Feature Source Type: blogs
Abstract INTRODUCTION: The pandemic caused by the novel coronavirus virus has altered all facets of clinical practice in the United States. The goal of this study is to better understand the impact of COVID-19 on rhinologic ambulatory and operative practice. METHODS: A 27-item survey to assess these objectives was created and approved by the Division of Rhinology faculty at Rush University Medical Center in April 2020. The survey was then distributed to rhinologists in a web based format via www.surveymonkey.com from April 10 through April 23, 2020. RESULTS: A total of 277 U.S based rhinologists responde...
Source: American Journal of Rhinology and Allergy - Category: ENT & OMF Authors: Tags: Am J Rhinol Allergy Source Type: research
Biologics have revolutionized medical therapy in the past 2 decades. Allergic Diseases have benefited from this revolution as a variety of biologics have impacted all categories of allergic diseases. Anticytokines directed at type 2 immunity has helped in the treatment of all allergic conditions covered in this issue ranging from Allergic Rhinitis to Asthma to Atopic Dermatitis to Food Allergy and others. Obviously, the ravages of COVID-19 on processes involved in biologic treatment are a consideration, but current thinking suggests such therapies should not be affected by the pandemic.
Source: Immunology and Allergy Clinics of North America - Category: Allergy & Immunology Authors: Tags: Preface Source Type: research
AbstractPurpose of ReviewCoding for patient visits and monitoring via telehealth have expanded over the past years with a wide acceptance of telemedicine as a consequence of the coronavirus pandemic. Coding topics of interest to the allergist/immunologist in regard to services provided via telemedicine will be of increasing importance in the coming years.Recent FindingsCPT coding for telephone as well as synchronous face-to-face telehealth visits has changed over the past few years. With the need for distancing and patient protection during the coronavirus pandemic, telehealth services have increased dramatically. The intr...
Source: Current Allergy and Asthma Reports - Category: Allergy & Immunology Source Type: research
The pandemic COVID-19 abruptly exploded, taking most health professionals around the world unprepared. Italy, the first European country to be hit violently, was forced to activate the lockdown in mid-February...
Source: Clinical and Molecular Allergy - Category: Allergy & Immunology Authors: Tags: Review Source Type: research
Source: Journal of Asthma and Allergy - Category: Allergy & Immunology Tags: Journal of Asthma and Allergy Source Type: research
The newly described severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) is responsible for a pandemic (Corona virus-induced disease -19, COVID-19). It is now well established that certain comorbidities define high risk patients. They include hypertension, diabetes, and coronary artery disease. In contrast, the context with bronchial asthma is controversial and shows marked regional differences. Since asthma is the most prevalent chronic inflammatory lung disease worldwide and SARS-CoV-2 primarily affects the upper and lower airways leading to marked inflammation, the question arises about the possible clinical an...
Source: Journal of Allergy and Clinical Immunology - Category: Allergy & Immunology Authors: Source Type: research
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