PDSA e-News: April 29, 2020



PDSA Medical Advisor Leading World’s Largest Clinical Trial of a Potential Treatment for COVID-19

Dr. Donald ArnoldWith COVID-19 spreading at an alarming rate internationally, the number of people requiring hospitalization to manage their symptoms increases each day. There is an urgent need worldwide for a cure or reliable treatment that can be made easily accessible to those in need. One of PDSA’s medical advisors, Dr. Donald Arnold, from Hamilton, Ontario Canada, is leading a team of blood transfusion experts to determine the value of infusing plasma from patients who have recovered from COVID-19 into those currently hospitalized for the same virus.

Once an individual has had a particular virus and has fully recovered from it, their plasma contains a plethora of antibodies against that specific virus. These antibodies remain in their bloodstream ready to fight the virus should it return. When these antibodies are administered into another person with the same viral infection, the antibodies should recognize the virus and provide a boost to the recipient’s immune system. This immune system boost could help eliminate the virus while improving the outcome by reducing the severity of symptoms such as respiratory distress. This in turn would decrease the length of hospital admissions and reduce the need for ventilators and the number of covid-19 fatalities. This type of treatment is called convalescence hyperimmune therapy and it has been used to treat other deadly viruses for over 100 years, including other corona-type viruses such as SARS and MERS. There are only a small number of alike trials to date with limited patient enrollment, and these smaller studies have shown this treatment to be effective in managing COVID-19. However, none of these previous studies have included a control-group which is essential in clinical trials to determine true therapeutic efficacy.

https://www.theglobeandmail.com/canada/article-canada-begins-clinical-trial-of-experimental-covid-19-treatment-using/

What’s happening in the USA?

In the USA, trials are beginning to emerge to also look at the benefits of using convalescent plasma to treat COVID-19 patients but single arm studies are also ongoing. This therapy is still under investigation through the Food and Drug Administration (FDA), however the regulations around it’s use have recently loosened in light of COVID-19. Since late March, the FDA helped patients access this treatment through clinical trials or expanded access programs overseen by medical professionals. The FDA has also been granting permission in a quick manner to physicians who request to use the treatment in emergency situations. The NY Blood Center has already released more than 400 units of convalescent plasma to treat over 200 patients. The Mayo Clinic has an Expanded Access Program that provides convalescent plasma to patients with COVID-19 who have symptoms on the severe end of the spectrum and are determined to be critical or at high risk to become critical. https://www.uscovidplasma.org/. Some trials are focused on determining the benefits of this type of therapy in treating mild-moderately affected infected patients, while others will focus on the treating pediatric patients or those with compromised immune systems. Countries all over the world are interested in the proposed therapeutic benefits of using convalescent plasma to help treat COVID-19. The American Society of Hematology has developed a patient-friendly web link to provide further education on convalescent therapy and COVID-19. https://www.hematology.org/covid-19/covid-19-and-convalescent-plasma.


Immune Thrombocytopenia: a case study from the New England Journal of Medicine

PlateletsThrough the use of a clinical case vignette, an evidence-based approach to the complicated management and treatment of ITP in an elderly patient presenting with a gastrointestinal bleed while on anticoagulants is comprehensively discussed. A thorough overview of ITP is provided within the review paper including present-day methods employed for making a diagnosis and treating active bleeding in adults. Difficulties in predicting bleeding episodes in ITP is covered in addition to a review of available treatment options for adults. The authors discuss how both current guidelines and evidence-based literature play a role in treatment decisions. Variables such as age and comorbid conditions are taken into consideration. Difficulties in managing the dilemma of preventing bleeding while preventing too much clotting are covered.

For the case presented in this review, treatments were essential to control the bleed and recommended to be used to prevent another bleed. The authors, PDSA Medical Advisor Nichola Cooper, M.D., M.B. B.S. and Waleed Ghanima, M.B., Ch.B, Ph.D, discuss how anticoagulants are discontinued in this situation until the internal bleeding is stopped using platelet transfusion, IVIG, and corticosteroids in a synergistic manner. Once stable, exclusion of secondary thrombocytopenia is recommended in addition to prevention of a second serious bleed. Anticoagulant use can be restored when a safer platelet count of at least 30-50,000μL is reached depending on the seriousness of bleeding. The authors suggest maintaining a safer platelet count may be easier using a thrombopoietin (TPO) receptor agonist over Rituximab if remission did not occur following rituximab treatment, in order to treat the gastrointestinal bleed.

https://www.nejm.org/doi/full/10.1056/NEJMcp1810479


 

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