{"id":1508,"date":"2023-05-08T17:48:23","date_gmt":"2023-05-09T00:48:23","guid":{"rendered":"https:\/\/blog.medcram.com\/?p=1508"},"modified":"2023-05-26T18:07:58","modified_gmt":"2023-05-27T01:07:58","slug":"vilobelimab-for-severe-covid-19-and-possibly-other-diseases","status":"publish","type":"post","link":"https:\/\/blog.medcram.com\/covid-19\/vilobelimab-for-severe-covid-19-and-possibly-other-diseases\/","title":{"rendered":"Vilobelimab for Severe Covid-19 and possibly other diseases"},"content":{"rendered":"<p style=\"text-align: center;\"><iframe loading=\"lazy\" title=\"YouTube video player\" src=\"https:\/\/www.youtube.com\/embed\/MVqeeVlmWZ4\" width=\"560\" height=\"315\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\"><\/iframe><\/p>\n<p><span style=\"font-weight: 400;\">In this latest MedCram video, Dr. Seheult discusses a promising new drug that is being added to the arsenal of treatments against COVID-19. It is a new monoclonal antibody called vilobelimab.\u00a0<\/span><\/p>\n<h2>What does vilobelimab do?<\/h2>\n<p><span style=\"font-weight: 400;\">This drug has been given emergency use authorization not only for COVID-19 but it may also be applied to other scenarios.\u00a0 This new medication is a monoclonal antibody drug but uses a completely different mechanism than previous monoclonal antibodies that were used during the COVID-19 pandemic.\u00a0 It does not involve the spike protein. This antibody is directed against proteins that are endogenous to the human body and not anything on a specific virus.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Ways to improve the immune system<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">MedCram has discussed multiple other modalities to improve your immune system such as <\/span><a href=\"https:\/\/www.youtube.com\/watch?v=2Zzo4SJopcY\"><span style=\"font-weight: 400;\">sunlight<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/www.youtube.com\/watch?v=ZdiUnmpOgqE\"><span style=\"font-weight: 400;\">near infrared light<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/www.youtube.com\/watch?v=EFRwnhfWXxo\"><span style=\"font-weight: 400;\">hydrotherapy<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/www.youtube.com\/watch?v=5YV_iKnzDRg&amp;t=117s\"><span style=\"font-weight: 400;\">vitamin d<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/www.youtube.com\/watch?v=xRkRilP1OTU\"><span style=\"font-weight: 400;\">nutrition<\/span><\/a><span style=\"font-weight: 400;\">,\u00a0 <\/span><a href=\"https:\/\/www.youtube.com\/watch?v=22Bn8jsGI54\"><span style=\"font-weight: 400;\">oxidative stress<\/span><\/a><span style=\"font-weight: 400;\">, and<\/span><a href=\"https:\/\/www.youtube.com\/watch?v=PgDjVEpEOdQ\"><span style=\"font-weight: 400;\"> fresh air<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p>\n<h2>What is ARDS?<\/h2>\n<p><span style=\"font-weight: 400;\">ARDS\u00a0 (acute respiratory distress syndrome) is the final common pathway for many viral illnesses, not only SARS-CoV-2. ARDS can lead to fibrosis in the lungs which affects the ability for oxygen to diffuse across the tissues and the ability of the lung to stretch with breathing. This can cause permanent disability. The fibrosis is caused by a person\u2019s own immune system due to it getting ramped up too much.\u00a0\u00a0<\/span><\/p>\n<h2>How does the complement cascade work in ARDS?<\/h2>\n<p><span style=\"font-weight: 400;\">The innate immune system is a portion of the immune system that deals with antigens but in a way that is not dependent on a particular type of antigen. It is dependent on proteins within a protein complex known as the complement cascade.\u00a0 Within this cascade you come to a protein called C5b and C5a. C5b goes on to combine with C6,C7,C8, and C9 to form a cylindrical complex membrane that can attack cells. This type of attack is very important in cases of meningitis. C5a goes on to become an anaphylatoxin which attracts other cells to the site of infection and causes damage to the surrounding area. It is often found in ARDS. If you can decrease the C5a response you can potentially reduce the inflammatory response that comes as a result of it.\u00a0 <\/span><\/p>\n<h2>How does the new monoclonal antibody work?<\/h2>\n<p><span style=\"font-weight: 400;\">There are a few drugs that are available to try and block potential points of the complement cascade. Eculizumab, a different monoclonal antibody, is an antibody against C5 which is normally cleaved into C5a and C5b. The downside of this is the decreased levels of C5b which can interfere with the body\u2019s ability to create the cylindrical membrane attack complex which essentially helps with killing unwanted cells or viruses in the body. Patients who receive eculizumab must be vaccinated against meningitis.\u00a0 Vilobelimab, the new drug, focuses only on the arm that decreases C5a. It is essentially a monoclonal antibody against C5a so it doesn\u2019t interfere with C5b and its actions. Eculizumab in a study did not prevent or reduce C5a generation as there is another enzyme, trypsin, which can also cleave it from C5. This is important to realize since eculizumab doesn\u2019t decrease C5a, then it most likely won\u2019t reduce the inflammatory changes that are associated with it.\u00a0 <\/span><\/p>\n<h2>What did the vilobelimab trial show?<\/h2>\n<p><span style=\"font-weight: 400;\">The <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC9451499\/pdf\/main.pdf\"><span style=\"font-weight: 400;\">phase 3 trial<\/span><\/a><span style=\"font-weight: 400;\"> done with vilobelimab was a multicenter double-blinded randomized control trial. The total patients was 368 with 177 patients in the intervention arm and 191 in the placebo arm. It was done across 46 hospitals in Europe, North America, South America and Africa. The patients had to be 18+, on mechanical ventilation for less than 48 hours with moderate to severe ARDS. The intervention was standard of care plus vilobelimab 800 mg IV on days 1,2,4,8,15 and 22. The endpoint was all-cause mortality at 28 days. The study was originally done apriori with no site stratification. However, the FDA wanted site stratification which meant they did not want to include any information from the smaller sites if there were no deaths at those sites.\u00a0 Due to this, 61 people were eliminated from the study and the number went from 368 to 307. This would reduce the power of the study. So when the study was stratified by site it didn\u2019t make statistical significance. However, if the original version of the study protocol was used without site stratification, then there was a significant reduction in all-cause mortality and there was statistical significance. It was because of this that the FDA allowed them to get EUA.\u00a0 The study did not show any statistical significance towards kidney injury; however, it was noted that vilobelimab seemed to protect against dialysis. On the subgroup analysis it appears that patient\u2019s with more severe disease and lower GFR&lt;60 did meet statistical significance as compared to\u00a0 those with moderate disease and GFR&gt;60.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">For safety, these patients are very sick patients and anything can happen. Once the drug is infused anything that happens afterward is attributed to the drug so the adverse events were high in both the infusion group as well as the placebo group at 91%. There was no major difference between the most common adverse events other than there was an increased incidence of pneumonia in the intervention group; however, this can be accounted for by the fact that there was a statistical decrease in mortality with vilobeimab and that patients that were still alive could develop pneumonia as dead people don\u2019t have pneumonia. There were no cases of bacterial meningitis seen.\u00a0<\/span><\/p>\n<h2>What is the potential of vilobelimab?<\/h2>\n<p><span style=\"font-weight: 400;\">Currently we are not seeing a lot of hospitalizations in the U.S. from COVID-19;however, in the instance that a patient comes in to the hospital and ends up on the ventilator within 48 hours, this is a new \u201ctool\u201d in the \u201ctool shed\u201d that can be used for treatment. One positive aspect of this drug is that it is a monoclonal antibody where you don&#8217;t have to worry about the spike protein or sub variants that may arise in the future because it is not against the spike protein but instead is against C5a which causes inflammation. So the question is could this medication also work against other viral pandemics?\u00a0 There was a <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7112341\/\"><span style=\"font-weight: 400;\">study <\/span><\/a><span style=\"font-weight: 400;\">published in 2015 that looked at H7N9 viral infection that looked at African green monkeys. They looked at the vilobeimab in treatment of this and they found that there appeared to be improved outcomes in the monkeys treated with the drug.\u00a0\u00a0<\/span><\/p>\n<h2>Vilobelimab factsheet<\/h2>\n<p><span style=\"font-weight: 400;\">Today there are still people being admitted with severe COVID and this drug currently under emergency use authorization.\u00a0 Here is the <\/span><a href=\"https:\/\/www.fda.gov\/media\/166824\/download\"><span style=\"font-weight: 400;\">factsheet<\/span><\/a><span style=\"font-weight: 400;\"> for those that may need it for the drug. As always, more research is needed. If you are taking care of COVID 19 patients on the ventilator, MedCram has a<\/span><a href=\"https:\/\/www.medcram.com\/courses\/COVID19-ventilator-mechanical-ventilation\"><span style=\"font-weight: 400;\"> free course on mechanical ventilation<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">LINKS \/ REFERENCES:<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Controlling the anaphylatoxin C5a in diseases requires a specifically targeted inhibition (Clinical Immunology) |<\/span><a href=\"https:\/\/www.youtube.com\/redirect?event=video_description&amp;redir_token=QUFFLUhqa2hxNUlZekNLNHQ1QVNXRWhSdXdCbWFlcVd5Z3xBQ3Jtc0trVkZjeUUtbmRqc1FmeUlrMjBDaXN4SXVNZnlhT1dnOWdPZi1NbDBwMnBwaVRsYkR6Y2cwZmtzdlFEZThLZ1JOM3p0VE5QaWlGYjVSS2wzdWlVYXItM0ppcW5QVW9wTFNpekZ2cmZIOVd5TzRuVkx5bw&amp;q=https%3A%2F%2Fwww.sciencedirect.com%2Fscience%2Farticle%2Fabs%2Fpii%2FS1521661617301729%3Fvia%253Dihub&amp;v=MVqeeVlmWZ4\"> <span style=\"font-weight: 400;\">https:\/\/www.sciencedirect.com\/science&#8230;<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\">The anti-C5a antibody vilobelimab efficiently inhibits C5a in patients with severe COVID-19 (Clinical and translational science) |<\/span><a href=\"https:\/\/www.youtube.com\/redirect?event=video_description&amp;redir_token=QUFFLUhqbjl1eXktdWs4endfa2Z4eFZKVGZoR1IyY015UXxBQ3Jtc0ttWXB6LXhwMVg1X2xOSFM3Y2VHaTlqcE5kQ1ZDWVNHb0JJNXZGY3ZINGpKdHk0dUNGQXkwUlUtdDZrakYzcXJGMFNZQ1RweWFGVkcwdEN6eDBVbTdlZ253NkwzSS1NczBmdXh1ZmtzVkJBM3AyaC1mRQ&amp;q=https%3A%2F%2Fpubmed.ncbi.nlm.nih.gov%2F35029045%2F&amp;v=MVqeeVlmWZ4\"> <span style=\"font-weight: 400;\">https:\/\/pubmed.ncbi.nlm.nih.gov\/35029&#8230;<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\">Anti-C5a antibody (vilobelimab) therapy for critically ill, invasively mechanically ventilated patients with COVID-19 (PANAMO): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial (Lancet Respir Med) |<\/span><a href=\"https:\/\/www.youtube.com\/redirect?event=video_description&amp;redir_token=QUFFLUhqbWVNUUZpQXJfTmRNeHkxcEJwUlhpQWFwVkZid3xBQ3Jtc0trV0VsSFhpSWg4T19CZDZxOUxnaHBXMHZlLWdTWXp2LWJIdUNvSjdFV2lWWUdBWlhvdnd1UlU0U1lGWFBTNkd3Q1Bsaml2MERfYzZ1TGdvSEdoTklVa0FtZDMtWnNSM29td01iZ2Zndnp0RzFTdGlfYw&amp;q=https%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC9451499%2Fpdf%2Fmain.pdf&amp;v=MVqeeVlmWZ4\"> <span style=\"font-weight: 400;\">https:\/\/www.ncbi.nlm.nih.gov\/pmc\/arti&#8230;<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\">Treatment With Anti-C5a Antibody Improves the Outcome of H7N9 Virus Infection in African Green Monkeys (Clinical infectious diseases) |<\/span><a href=\"https:\/\/www.youtube.com\/redirect?event=video_description&amp;redir_token=QUFFLUhqbmh0Q29QVzJMNWVXdnc4dnRodUw4SDFYeDVwQXxBQ3Jtc0tsWFJLUnZudHBSQkxKVTQ4UDBqVUZpS3Z0ZTJJRUIybFVnU0VZRTBCUGZzUW9IN0xzNmNBUmFtTHFzR1Q1UlBfVUxNSF9UUUtzbjl6RXEyVjF3bGlSS084UUVUTG9za2pyUTJDck03OHE3OHFSWThzcw&amp;q=https%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC7112341%2F&amp;v=MVqeeVlmWZ4\"> <span style=\"font-weight: 400;\">https:\/\/www.ncbi.nlm.nih.gov\/pmc\/arti&#8230;<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\">FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR GOHIBIC (FDA) |<\/span><a href=\"https:\/\/www.youtube.com\/redirect?event=video_description&amp;redir_token=QUFFLUhqa2ZTXzAweWhTUDJOa2ZCS19tNXFNc1I5MHVqZ3xBQ3Jtc0tsVHVKYWRUalRaa2xqNVRIQmlUanZJb0RaTVBjbms2cHdaSnRNaHVrVU1vZm9JaWVJa0IwT0Q3eE5PczNFTGluSVRjdVozdy1Fd2VscDVDTjdoTkpPdlMxV2NhNGh6M0RhZFFTN3BuRlI5YnZRUGpvQQ&amp;q=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F166824%2Fdownload&amp;v=MVqeeVlmWZ4\"> <span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/media\/166824\/down&#8230;<\/span><\/a><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">COVID-19 Ventilator Course: Learn or Review Mechanical Ventilation (MedCram) |<\/span><a href=\"https:\/\/www.youtube.com\/redirect?event=video_description&amp;redir_token=QUFFLUhqbnN0R1dxRWFuazhXMlFQaER6eWFodkNlS3dhd3xBQ3Jtc0tuV19mWlhJLVo5U3NzU0VKRmxFMFNkOFc3UUFFcWxZTmwxRWtfUmhzai1ZQjU4cWlXbnhVTVVMR1FUenZGYjhrM3FibVQwZTZIdGdtdVJuU0pKbEdZMVNUMDBFeGZZOHZVeHFEa0JYT2JrVzNlUmlHWQ&amp;q=https%3A%2F%2Fwww.medcram.com%2Fcourses%2FCOVID19-ventilator-mechanical-ventilation&amp;v=MVqeeVlmWZ4\"> <span style=\"font-weight: 400;\">https:\/\/www.medcram.com\/courses\/COVID&#8230;<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\">All coronavirus updates are at MedCram.com (including more discussion on delta variant covid, COVID Delta, COVID children, natural immunity COVID 19, and more).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">MedCram Update 46:<\/span><a href=\"https:\/\/www.youtube.com\/watch?v=EFRwnhfWXxo&amp;t=0s\"> <span style=\"font-weight: 400;\">\u00a0\u00a0<\/span><span style=\"font-weight: 400;\"> \u2022 Coronavirus Pande&#8230;\u00a0\u00a0<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\">MedCram Update 47:<\/span><a href=\"https:\/\/www.youtube.com\/watch?v=H1LHgyfPPQ8&amp;t=0s\"> <span style=\"font-weight: 400;\">\u00a0\u00a0<\/span><span style=\"font-weight: 400;\"> \u2022 Coronavirus Pande&#8230;\u00a0\u00a0<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\">MedCram Update 132:<\/span><a href=\"https:\/\/www.youtube.com\/watch?v=9OZZ6_M4OB0&amp;t=0s\"> <span style=\"font-weight: 400;\">\u00a0\u00a0<\/span><span style=\"font-weight: 400;\"> \u2022 Innate Immunity, &#8230;\u00a0 <\/span><\/a><\/p>\n<!-- AddThis Advanced Settings generic via filter on the_content --><!-- AddThis Share Buttons generic via filter on the_content -->","protected":false},"excerpt":{"rendered":"<p>In this latest MedCram video, Dr. Seheult discusses a promising new drug that is being added to the arsenal of treatments against COVID-19. It is a new monoclonal antibody called vilobelimab.\u00a0 What does vilobelimab do? This drug has been given emergency use authorization not only for COVID-19 but it may also be applied to other&hellip;<!-- AddThis Advanced Settings generic via filter on get_the_excerpt --><!-- AddThis Share Buttons generic via filter on get_the_excerpt --><\/p>\n","protected":false},"author":8,"featured_media":1509,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[25],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Vilobelimab for Severe Covid-19 and possibly other diseases - Medcram Blog<\/title>\n<meta name=\"description\" content=\"In this latest MedCram video, Dr. Seheult discusses a promising new drug that is being added to the arsenal of treatments against COVID-19. It is a new monoclonal antibody called vilobelimab.\u00a0\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/blog.medcram.com\/covid-19\/vilobelimab-for-severe-covid-19-and-possibly-other-diseases\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Vilobelimab for Severe Covid-19 and possibly other diseases - Medcram Blog\" \/>\n<meta property=\"og:description\" content=\"In this latest MedCram video, Dr. Seheult discusses a promising new drug that is being added to the arsenal of treatments against COVID-19. 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