NIH begins large clinical trial to test immune modulators for treatment of COVID-19

The National Institutes of Health 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. 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, 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.Continue reading

An Open Letter from Daniel O’Day, Chairman & CEO, Gilead Sciences: October 8, 2020

Daniel O’Day – October 08, 2020

With today’s publication of new data on remdesivir in the New England Journal of Medicine, we have the clearest picture yet of the medicine’s impact on COVID-19. Over the past months, we had already generated a wealth of clinical data on the benefits of remdesivir, providing much-needed hope to patients and healthcare providers worldwide. On the basis of this data, remdesivir has been approved or authorized for temporary use to treat COVID-19 in more than 50 countries worldwide. Today’s peer-reviewed data come from the gold standard randomized, double-blind, placebo-controlled Phase 3 study led by the U.S National Institute of Allergy and Infectious Diseases (NIAID). They provide new information that expands on the benefits of remdesivir and offer greater hope than ever in the fight against COVID-19.Continue reading

Lilly announces proof of concept data for neutralizing antibody LY-CoV555 in the COVID-19 outpatient setting

– Primary endpoint of viral load change from baseline at day 11 was met for one of three doses; consistent effects of viral reduction seen at earlier time points

– Rate of hospitalizations and ER visits was 1.7 percent (5/302) for LY-CoV555 versus 6 percent (9/150) for placebo–a 72 percent risk reduction in this limited population

– LY-CoV555 was well-tolerated across all doses with no drug-related serious adverse events reported
INDIANAPOLIS, Sept. 16, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced proof of concept data from an interim analysis of the BLAZE-1 clinical trial, showing a reduced rate of hospitalization for patients treated with LY-CoV555. The randomized, double-blind, placebo-controlled Phase 2 study evaluated LY-CoV555, a SARS-CoV-2 neutralizing antibody, for the treatment of symptomatic COVID-19 in the outpatient setting. The trial enrolled mild-to-moderate recently diagnosed COVID-19 patients across four groups (placebo, 700 mg, 2800 mg, and 7000 mg).Continue reading

Lab Tests: ClōSYS Oral Rinse Eliminated COVID-19 Virus up to 98.4% in 30 Seconds

SCOTTSDALE, Ariz. (Aug. 31, 2020) — Rowpar Pharmaceuticals Inc., the makers of the ClōSYS brand of toothpastes, mouthwashes and oral sprays, announced today that an in vitro laboratory analysis showed that ClōSYS Ultra Sensitive Oral Rinse reduced SARS-CoV-2 (COVID-19 virus) up to 98.4% within 30 seconds without the use of any harsh chemicals like alcohol, hydrogen peroxide or povidone iodine.Continue reading