Octapharma Reports Positive Data from octagam ® Usage in Critically Ill COVID-19 Patients
Topline results from a retrospective study in 93 critically ill COVID-19 patients have become available. The data shows that IVIG treatment reduces inflammation, which is associated with poor clinical outcomes and death, and points to an increase in survival, in critically ill COVID-19 patients, when compared to a control group. The study was conducted at the Istanbul University Hospital, Turkey, under the lead of Prof. Dr. Figen Esen.
In critically ill COVID-19 patients, the cause of death often implicates an abnormal pulmonary immune response. This abnormal immune response is characterized by high levels of inflammatory markers, which are associated with poor clinical outcomes.1, 2 Acute respiratory distress syndrome (ARDS) and multiorgan failure are major causes of mortality in COVID-19 patients.3 High levels of pro-inflammatory cytokines and chemokines are part of a severe inflammatory response known as a “cytokine storm” which may cause multiple organ dysfunction and ARDS in critically ill COVID-19 patients.4
There is no known effective treatment for patients infected with COVID-19, except for remdesivir and dexamethasone.
Early treatment of COVID-19 patients with systemic immune modulators such as IVIG may reduce aberrant immune responses and the subsequent inflammatory responses, which are observed in the severe stages of ARDS and may cause lasting lung damage and death.5, 6
IVIG has been proven to protect from infections in immunodeficient patients and has also been increasingly recognized for its immunomodulatory and anti-inflammatory effects. Although the mechanisms of action of IVIG are not completely understood, it may modulate the immune response via multiple mechanisms, including blocking a wide array of pro-inflammatory cytokines that potentially lead to severe inflammatory responses, including cytokine storm, as well as Fc-gamma receptor binding of activated macrophages)4.
Octagam® (5% and 10%) is a polyvalent IVIG preparation that is approved in over 80 countries worldwide for the treatment of immunodeficiency and other immune disorders.
It is hypothesized that octagam® can treat critically ill COVID-19 patients by reducing and/or preventing hyperinflammation as it has been observed in severe disease.4
In the Istanbul University Hospital study, octagam® 5% was administered at approx. 0.4g/kg body weight for 5 consecutive days (2g/kg body weight total dose) to 51 critically ill COVID-19 patients, all requiring intensive care with intubation and mechanical ventilation. Biomarkers and clinical outcomes were compared with those of 42 critically ill COVID-19 patients who did not receive IVIG. Other treatments used in both treatment groups included favipiravir, hydroxychloroquine, azithromycin, oseltamivir, tocilizumab, and anakinra.
A higher survival rate was observed in the octagam® treatment group. At the end of the study, overall survival was 60.8% in the treatment group which received octagam®, versus 38.1% in the control group which did not receive IVIG (p = 0.0906 after controlling for baseline factors), corresponding to a trend of 2.2 times reduced risk of death when receiving IVIG.
At 6 days after start of treatment, the inflammatory marker C-reactive protein (CRP) was significantly reduced by 46% versus baseline in the IVIG group, whereas there was no reduction compared to baseline in the control group (p=0.0488).
Prof. Dr. Figen Esen, Head of the Intensive Care Department, Istanbul University Hospital, commented: “In the critical care setting, the management of sepsis includes modulation of the immune system and the host response. Whilst IVIG treatment in sepsis has shown positive beneficial effects in terms of infection and lowering inflammation and mortality, the relatively small amount of data generated from high quality clinical trials has prevented its widespread incorporation into clinical guidelines.
The clinical picture of severe COVID-19 in the critical care setting includes many of the same features as sepsis, however with a much more severe inflammatory chaos induced by cytokine storm. There is one other difference; here we do not have any proven effective treatments, apart from manipulating the patient’s immune system, either by augmenting or suppressing.
IVIG therapy presents a perfect choice to modulate the patient’s immune system and calm down the situation. Although our results have certain limitations, we have observed in routine clinical use of IVIG in severely ill COVID-19 patients, a significant reduction in inflammation in the group receiving IVIG treatment, leading to an improved clinical outcome in terms of a much higher survival rate.
We are happy to see the results of our data leading to further prospective randomized multicenter trials in severely ill COVID-19 patients, and we are really very excited to see the results”.
“These positive results from Istanbul University Hospital appear to demonstrate the immune-modulating properties of IVIG in severely-ill COVID-19 patients, in reducing hyperinflammation and the associated cytokine storm syndrome and improving clinical outcomes”, said Wolfgang Frenzel, M.D., Head of Research & Development at Octapharma. “We are hopeful of further positive results in our ongoing Phase 3, multicenter clinical trial on the efficacy and safety of octagam® 10% therapy in COVID-19 patients with severe disease progression, currently being conducted at a number of study sites in the USA”.
These results from Istanbul University Hospital contribute to a growing body of clinical evidence suggesting the role IVIG plays in increasing survival and improving clinical outcomes in critically ill COVID-19 patients, by preventing and/or reducing hyperinflammation and the associated cytokine storm syndrome.
Following on from this positive data from Istanbul University Hospital and also a prospective investigator-initiated study conducted by Dr George Sakoulas of Sharp Memorial Hospital in San Diego, USA), Octapharma has started a Phase 3, multicenter clinical trial on the efficacy and safety of octagam® 10% therapy in COVID-19 patients with severe disease progression.
This study is currently being conducted in various centers in the United States and compares the efficacy and safety of IVIG plus standard of care (SOC) versus placebo in the treatment of COVID-19 patients at risk of requiring mechanical ventilation.
Information about Octagam® 5%
Octagam® 5% is a ready to use, liquid preparation of highly purified immunoglobulin for intravenous administration (IVIG). It was originally approved in Europe in 1995, and is now approved in over 80 countries worldwide for the treatment of primary and secondary immunodeficiencies and a variety of other immune disorders. It is approved as immunomodulation therapy in immune thrombocytopenia (ITP), Guillain-Barré syndrome (GBS) and Kawasaki disease, chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy (MMN) in selected geographical areas.
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs more than 10,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Hematology, Immunotherapy, and Critical Care.
Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden, with a combined capacity of approximately 8 million litres of plasma per annum. In addition, Octapharma operates more than 140 plasma donation centres across Europe and the US.
For further information on the action of Octapharma in the fight against COVID-19 see this article.
1. Tisoncik JR, Korth MJ, Simmons CP, Farrar J, Martin TR, Katze MG. Into the eye of the cytokine storm. Microbiology and molecular biology reviews : MMBR 2012; 76(1) 16-32. https://www.ncbi.nlm.nih.gov/pubmed/22390970
2. Lee KY. Pneumonia, Acute Respiratory Distress Syndrome, and Early Immune-Modulator Therapy. International journal of molecular sciences 2017; 18(2). https://www.ncbi.nlm.nih.gov/pubmed/28208675
3. Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020; 46: 846-848. https://pubmed.ncbi.nlm.nih.gov/32125452/
4. Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. https://pubmed.ncbi.nlm.nih.gov/32192578/
5. Calabrese LH. Cytokine storm and the prospects for immunotherapy with COVID-19. Cleveland Clinic journal of medicine 2020. https://www.ncbi.nlm.nih.gov/pubmed/32393592
6. Wright DJM. Prevention of the cytokine storm in COVID-19. The Lancet Infectious diseases 2020. https://www.ncbi.nlm.nih.gov/pubmed/32386610
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Universal Peace Federation: Online Rally Calling for Peace, Reconciliation and Mutual Prosperity5.8.2020 12:42:00 CEST | Press release
(Sunday August 9th, 3 am CET) This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200805005488/en/ Dr. Hak Ja Han Moon, co-founder of the Universal Peace Federation & host of the Rally (Photo: Business Wire) More than 1 Million are expected to join! World Leaders to point the way forward beyond global challenges including Covid-19, race relations, environmental problems and global economic turndown. Speakers include former UN Secretary-General Ban Ki-moon and H.E. Macky Sall, President of Senegal. UPF Co-Founder Dr. Hak Ja Han will offer a special keynote message of hope to humanity. Registration link for online participants: https://www.rally2020.org World Leaders to Address “Rally of Hope” Despite material advances and the amassing of unprecedented wealth, serious global problems remain unsolved. This is all the more striking when it is seen alongside worldwide efforts to maintain peace, resolve conflicts and end poverty by maj
Prosperity Capital Management Provides Update to Petropavlovsk Shareholders5.8.2020 09:00:00 CEST | Press release
Prosperity Capital Management (“Prosperity”), a leading Russia-focused asset manager that controls approximately 20 per cent of the outstanding share capital of Petropavlovsk PLC (“the Company”), today updated Petropavlovsk shareholders on its efforts to reinstate an independent Board of Directors ahead of the Company’s Extraordinary General Meeting (“EGM”) to be held on 10 August. Prosperity has been engaging extensively with fellow Petropavlovsk shareholders – both large institutional shareholders and individual shareholders – as well as independent proxy advisory firms such as ISS and Glass Lewis. Support for Prosperity’s approach and its director nominees has been near unanimous. Prosperity believes that if all minority shareholders who are not affiliated with Everest Alliance (“Everest”) and JSC Uzhuralzoloto Group of Companies (“UGC”) make their voices heard, it should be manifestly evident once the votes are counted that support for the Everest-UGC position is almost nil. To put
Cherwell Now Offers Automated Discovery and Dependency Mapping (DDM) Powered by Resolve Systems5.8.2020 09:00:00 CEST | Press release
Cherwell Software LLC, a leading provider of IT Service Management (ITSM) and Enterprise Service Management (ESM) solutions, joins forces with Resolve Systems, a leader in enterprise automation and AIOps, to help companies better manage their complex IT environments through workflow automation and auto-discovery and dependency mapping. Cherwell is now an official reseller of Resolve products and can seamlessly deliver the integrated offering to their customers. Cherwell selected Resolve’s automated discovery and dependency mapping solution based on its robust capabilities and customer success. The collaboration between Resolve and Cherwell provides a complete solution for streamlining IT operations and accelerating service delivery. Combining best-in-class ITSM and robust discovery and dependency mapping immediately provides customers deep visibility into complex, hybrid environments, while also forging a strong foundation to advance AIOps initiatives. “By partnering with one of the le
Asahi Kasei Providing Samples of Hyaluronic Acid Nanogel as a New Pharmaceutical Excipient5.8.2020 04:00:00 CEST | Press release
Asahi Kasei has established industrial manufacturing technology for hyaluronic acid (HA) nanogel* as a new pharmaceutical excipient, and is providing samples to prospective customers in order to commercialize the product. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200804005334/en/ Chemical structure and self-assembly of HA nanogel (Graphic: Business Wire) The Functional Additives Division of Asahi Kasei’s Specialty Solutions SBU supplies Ceolus™ microcrystalline cellulose to pharmaceutical manufacturers around the world for use as an excipient for drug tablets. The commercialization of HA nanogel would expand the product lineup by adding a drug delivery system (DDS) base material for injection formulations. HA nanogel is expected to improve the quality of life (QOL) for patients by enabling the low-toxicity solubilization of insoluble drugs, facilitating the formulation of biopharmaceuticals such as proteins and peptides
RoboSense 80 Laser-Beam LiDAR RS-Ruby Lite Is Officially for Sale, Early-Bird Price $12,8004.8.2020 20:00:00 CEST | Press release
RoboSense http://www.robosense.ai/, the leading provider of smart LiDAR sensor, today launched an 80 laser-beam 3D sensing LiDAR ready for customer delivery with early-bird price of $12,800 (limited offer till 31st August, 2020), and standard price of $15,800. The timing of announcing this favorable package also marks the company's 6-year anniversary. The performance of the RS-Ruby Lite is close to that of the 128 laser-beam LiDAR RS-Ruby, with a vertical angular resolution of 0.1 degrees and 160m@10% ranging ability (with the longest detection range of 230 meters), making it suitable to address medium-and-high-speed autonomous driving applications with a price much more affordable to accelerate the commercialization of smart and safe transportation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200804005578/en/ The RS-Ruby Lite’s on-vehicle road-test point cloud image (Photo: Business Wire) Inheriting The Superb Performanc
Andersen Global Enters Chile With the Addition of Two Collaborating Firms4.8.2020 15:30:00 CEST | Press release
Andersen Global enters the Chilean market through Collaboration Agreements with two Santiago-based firms: law firm Chirgwin Peñafiel and tax firm SPASA Consulting. The firms are in close partnership with each other and add depth and breadth to the organization’s Latin American platform as it continues its steady expansion. Founded in 2009, Chirgwin Peñafiel, led by Office Managing Partner Andrés Chirgwin, is a full-service law firm specializing in commercial and corporate law, M&A, energy, labor law and banking & finance. The firm works with a variety of corporate clients, being strongly focused on providing legal support to multinational companies with operations in Chile, while also assisting Chilean-based companies with local and international legal needs. Chirgwin Peñafiel has been recognized by IFLR1000, Leaders League and Best Lawyers. “Our firm is committed to delivering quality, comprehensive solutions to our local and international clients,” Andrés said. “Andersen Global’s cap
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom