An anti-inflammatory compound may have the potential to treat systemic inflammation and brain injury in patients with severe COVID-19 and significantly reduce their chances of death, according to a new study fromUTHealth Houston和其他机构。

A team of researchers including UTHealth Houston faculty membersAaron M. Gusdon,MD, assistant professor in the Vivian L. Smith Department of Neurosurgery with McGovern Medical School at UTHealth Houston;H. Alex Choi，医学博士，该系的副教授以及神经病学系；和Louise D. McCullough, MD, PhD, professor and Roy M. and Phyllis Gough Huffington Distinguished Chair in the Department of Neurology, conducted a multi-site, randomized, double-blind, placebo-controlled, adaptive Phase 2 trial evaluating the safety and efficacy of an anti-inflammatory compound, called OP-101, in patients with severe COVID-19. The results of the trial were published today inScience Translational Medicine.

在该试验中，在美国五个临床部位中分类为严重的COVID-19的24例患者被随机分配，以2、4或8 mg/kg的身份接受单次静脉剂量的安慰剂或OP-101。所有患者都接受了包括皮质类固醇在内的护理标准。

“OP-101 is a novel nanotherapeutic compound that specifically targets activated macrophages and microglia, the primary immune cell in the brain,” said Gusdon, who was first author on the study. “Due to its excellent safety profile, we were excited to offer this therapy to these critically ill patients at Memorial Hermann Hospital.”

Hyperinflammation triggered by SARS-CoV-2 is a major cause of disease severity in COVID-19. OP-101 was found to be better than a placebo at decreasing inflammatory markers, as well as better at reducing markers of neurological injury, including neurofilament light chain and glial fibrillary acidic protein.

Additionally, risk for the composite outcome of mechanical ventilation or death at 30 or 60 days after treatment was 71% for patients receiving the placebo, but just 18% for patients in the pooled OP-101 treatment arms. At 60 days after treatment, 3 of 7 patients given placebo and 14 of 17 patients treated with OP-101 survived.

The data shows that OP-101 was well tolerated in the critically ill patient population and could serve as an effective treatment for patients hospitalized with COVID-19.

古斯登说：“尽管这是一项小剂量升级试验，但在急性和慢性时点，显然有强烈的信号。”“这种疗法也可能使导致全身性炎症反应的其他疾病患者受益，包括各种形式的脑损伤，这是非常令人兴奋的。”

OP-101 is a nanotherapeutic compound that has previously been evaluated in several animal models of inflammatory disease and has shown superior anti-inflammatory and anti-oxidant effects.

Covid-19-19导致全球感染超过3亿人，死亡超过500万。

Sujatha Kannan, MD, professor in the Department of Anesthesiology and Critical Care Medicine at Johns Hopkins University School of Medicine in Baltimore, Maryland, was senior author on the study. Other co-authors from Johns Hopkins University included Nauder Faraday, MD, and Rangaramanujam M. Kannan, PhD, both also with the medical school; and Derek K. Ng, PhD, with the Bloomberg School of Public Health.

Also contributing to the study were John S. Aita, MD, with Avera McKennan Hospital in Sioux Falls, South Dakota; Sunil Kumar, MD, with Broward Health Medical Center in Fort Lauderdale, Florida; Ishan Mehta, MD, with Emory University School of Medicine in Atlanta, Georgia; Jeffery L. Cleland, PhD, with Ashvattha Therapeutics, Inc. in San Francisco, California; and Keith Robinson, MD, with Syneos Health in Morrisville, North Carolina.

McCullough is also a faculty member with The University of Texas MD Anderson Cancer Center UTHealth Houston Graduate School of Biomedical Sciences.

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