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Archive - Oct 17, 2020

New Blood Test (IL-6/IL-10 Ratio) Can Predict Which COVID-19 Patients Will Develop Severe Infection, Results Suggest

Scientists have developed, for the first time, a score that can accurately predict which patients will develop a severe form of Covid-19. The study, led by researchers at RCSI (Royal College of Surgeons in Ireland) University of Medicine and Health Sciences, was published published online on October 8, 2020 in The Lancet's translational research journal EBioMedicine (https://doi.org/10.1016/j.ebiom.2020.103026). The open-access article is titled “A Linear Prognostic Score Based on the Ratio of Interleukin-6 to Interleukin-10 Predicts Outcomes in COVID-19.” The measurement, called the Dublin-Boston score, is designed to enable clinicians to make more informed decisions when identifying patients who may benefit from therapies, such as steroids, and admission to intensive care units. Until this study, no COVID-19-specific prognostic scores were available to guide clinical decision-making. The Dublin-Boston score can now accurately predict how severe the infection will be on day seven after measuring the patient's blood for the first four days. The blood test works by measuring the levels of two molecules that send messages to the body's immune system and control inflammation. One of these molecules, interleukin (IL)-6, is pro-inflammatory, and a different one, called IL-10, is anti-inflammatory. The levels of both are altered in severe Covid-19 patients. Based on the changes in the ratio of these two molecules over time, the researchers developed a point system where each 1-point increase was associated with a 5.6 times increased odds for a more severe outcome. "The Dublin-Boston score is easily calculated and can be applied to all hospitalized COVID-19 patients," said RCSI Professor of Medicine Gerry McElvaney, the study's senior author and a consultant in Ireland’s Beaumont Hospital.

NIH Begins Large Phase 3 Clinical Trial to Test Immune Modulators for Treatment of COVID-19; Trial Will Test Infliximab (Johnson & Johnson), Abatacept (Bristol Myers Squibb), and Cenicriviroc (AbbieVie)

On October 16, 2020, it was announced that the NIH has launched an adaptive Phase 3 clinical trial to evaluate the safety and efficacy of three immune modulator drugs in hospitalized adults with COVID-19(see larger image of SARS-CoV-2-infected cell at end). Some COVID-19 patients experience an immune response in which the immune system unleashes excessive amounts of proteins that trigger inflammation--called a “cytokine storm”--that can lead to acute respiratory distress syndrome (ARDS), multiple organ failure, and other life-threatening complications. The clinical trial aims to determine if modulating that immune response can reduce the need for ventilators and shorten hospital stays. The trial, known as ACTIV-1 Immune Modulators (IM), will determine if the therapeutics are able to restore balance to an overactive immune system. Part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) (https://www.nih.gov/research-training/medical-research-initiatives/activ) initiative, the trial expects to enroll approximately 2,100 hospitalized adults with moderate to severe COVID-19 at medical facilities in the United States and Latin America. The National Center for Advancing Translational Sciences (NCATS), part of NIH, will coordinate and oversee the trial with funding support from the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, in support of the Trump administration’s Operation Warp Speed (https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html goals.