Cole Maguire
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ACTIV-4 Preliminary Results Demonstrate Efficacy of Blood Thinners in Severe COVID-19 Patients
Written by: Cole Maguire Edited by: Esther Melamed Throughout the course of the COVID-19 pandemic, it has been recognized that a number of pressing secondary pathologies often develop in patients with severe COVID-19 disease. One of these secondary pathologies is COVID Associated Coagulopathy (CAC), which results in an over-abundance of clotting in the body and can…
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Pfizer and BioNTech Vaccine Efficacy, Remdesivir officially FDA approved, and Bamlanivimab gains EUA
Over the previous month, there have been many exciting advances in the arena of COVID-19 clinical trials. To start, recently Pfizer and BioNTech announced 90% efficacy (at 7 days post the second dose) in their BNT162b2 COVID-19 mRNA vaccine candidate. It is important to remember that these patients are not having their SARS-CoV-2 antibodies titers…
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WHO SOLIDARITY Trial Findings, Tocilizumab in COVID-19, and New NIH COVID-19 Clinical Trials
The first clinical trial update for this week is the recent publication on Tocilizumab in COVID-19 (Stone JH, et al. 2020). Tocilizumab is an anti-IL-6 receptor monoclonal antibody (mAb) that was being tested as a potential treatment for COVID-19 associated IL-6 cytokine storm. The study demonstrated no efficacy of Tocilizumab in reducing intubation or death…
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NIH’s new trial, New Remdesivir and Baricitinib Results, and Vaccine Testing in Older Adults
Over the past weeks there have been several exciting updates in COVID-19 clinical trials. The first are some results released from the ACTT-2 trial, which is evaluating combined Remdesivir with Barcitinib (a JAK inhibitor). This trial, in collaboration with Eli Lily, reported beneficial outcomes of the combined therapy in reducing COVID-19mortality by 35% (by Day…
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Pfizer’s new antiviral, the fourth phase III trial for a SARS-CoV-2 vaccine begins, and NIH expansion of convalescent plasma trials for COVID-19
There have been many advances in clinical trials over the past two weeks. The first large announcement is Pfizer’s antiviral, PF-07304814, is entering phase I trials (NCT04535167). This antiviral was originally developed in the SARS-CoV-1 outbreak, but was ended prematurely in trials due to a lack of demand. However, Pfizer has reported in a pre-print…
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What Does AstraZeneca’s Temporary Halt Phase III Vaccine Trials Mean and the NIH’s Latest Announcement on ACTIV-4
Over the past two weeks, the AstraZeneca/Oxford AZD1222 phase III vaccine trials have had a bumpy road. The phase III trials were temporarily halted after a participant developed neurological symptoms and was later diagnosed with transverse myelitis. This is the second temporary halt of AZD1222 trials, after a similar incidence with a participant having neurological…
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NIH Uncertain about Convalescent Plasma, Sanofi’s anti-IL6 Receptor mAb phase III trials show no results, and AstraZeneca bring their Adenovirus vaccine to the US
Last week, there were several interesting updates on the front of COVID-19 clinical trials. The first one is a statement released by the NIH which expresses disapproval of the recent emergency use authorization (EUA) granted by the Food and Drug Administration for convalescent plasma. The NIH raised concerns about the lack of data, particularly from…
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The FDA’s latest EUA for Convalescent Plasma, AstraZeneca’s new antibody cocktail, and new mRNA vaccine storage details
The FDA has now given an emergency use authorization (EUA) to the use of convalescent plasma in treating severe COVID-19. Convalescent plasma contains antibodies from patients who have recovered from COVID-19 and is a common therapy tested in any novel infection. However, convalescent plasma has many limitations that monoclonal antibodies seek to solve (check out…
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The Current Position of COVID-19 mRNA Vaccines in the US
In the dire face of the COVID-19 pandemic, many biotech companies took flight and immediately went into development of SARS-CoV-2 vaccines. Over time some of these companies have moved faster through clinical trials and have secured government sponsorships to help bring the vaccines faster to market. As a result, the US currently has several vaccines…