Clinical trial explores use of traditional Chinese medicine against COVID-19 > News > USC Dornsife

The pilot study focuses on a combination of 13 traditional medicinal compounds used in China at the start of the coronavirus outbreak. [5 min read]

Shortly after the novel coronavirus SARS-CoV-2 emerged and spread in the Chinese city of Wuhan, China’s pandemic response team turned to traditional medicine to understand and treat the new disease. A therapy that has emerged is a new cocktail derived from old therapies.

The therapy has been widely used in Wuhan, and hospitals that have treated patients there have seen significant success compared to those that have not. However, formal clinical trials designed to scientifically show whether the therapy is effective and to produce a detailed understanding of side effects were not conducted in the initial outbreak.

Now researchers from USC Dornsife College of Letters, Arts and Sciences and USC’s Keck School of Medicine have devised a plan to study traditional medicine used in Wuhan to counter the severe and often life-threatening symptoms that many COVID-19 patients are experiencing.

The pilot study examines the use of Xuanfei Baidu granules (XFBD) for COVID-19 patients with mild to moderate symptoms.

A cocktail of traditional Chinese medicinal compounds

Physician Zhang Boli, President of Tianjin University of Traditional Chinese Medicine, and his team, drawing on generations of knowledge, created XFBD using a combination of 13 distinct medicinal compounds targeting various symptoms of COVID-19.

The blend includes compounds believed to reduce fever, eliminate viruses, suppress coughs, help clear phlegm from the lungs, soothe the muscles of the trachea and relieve shortness of breath.

Additionally, an ingredient is believed to provide a mild anticoagulant effect, possibly dissolving or preventing blood clots which may pose a serious danger to COVID-19 patients.

The need for treatment options continues

Currently, there are few options for mild or moderate cases of COVID-19. Pharmacological treatments – such as antivirals and anti-inflammatories – are only slowly becoming available, with an initial focus on severe cases and hospitalized patients.

While the number of cases in the United States has dropped significantly in recent weeks, the threat of a new surge still looms, especially at the current rate of vaccine distribution and as new, more contagious variants of the virus emerge.

“We hope and should expect to move from the uncontrolled outbreak and the resulting need for mitigation to rapid containment of small outbreaks over the next 12-18 months. Continued vigilance, social distancing measures and the distribution of vaccines will be a key factor in this successful transition, but so will the availability of drugs which can reduce the risk of progression to serious illness,” said Peter Kuhn, Dean’s Professor of Biological Sciences and Professor of Biological Sciences, Medicine, Biomedical Engineering, Aerospace and Mechanical Engineering, and Urology at USC Dornsife.

Kuhn, a founding member of the Bridge Institute at the USC Michelson Center for Convergent Bioscience, is co-principal investigator of the study with collaborator Darcy Spicer, associate professor of clinical medicine and chief of the division of oncology in the Department of Medicine at Keck School of Medicine.

Building on years of collaborative science

Although no clinical studies examining XFBD have been undertaken, there is some evidence that traditional Chinese medicines may help. Before the widespread use of traditional medicines, China saw 10% of its mild and moderate cases progress in severity. As the use of traditional medicine became more common, the number of progressing cases fell, with only 2-5% experiencing worsening disease.

Kuhn and Spicer, along with USC Dornsife postdoctoral researcher Elizabeth Qi, worked together to design a study that can scientifically determine what effect, if any, XFBD has on the progression of COVID-19.

Kuhn, who holds joint positions at the Keck School of Medicine and the USC Viterbi School of Engineering, previously studied the SARS virus responsible for the 2003 outbreak in Asia, said he began discussing the current virus, SARS-CoV-2, and the disease it causes. , COVID-19, in early 2020 as the pandemic took hold in the United States.

“These conversations quickly focused on testing and therapeutic strategies,” Kuhn said. An exchange, with entrepreneur Ming Hsieh, president and CEO of Fulgent Genetics and administrator of USC, focused on what researchers in China had learned about the virus and the disease. This led to a formal collaboration between the USC team, Fulgent, and scientists at Tianjin University of Traditional Chinese Medicine, who developed XFBD.

“We are excited to partner with esteemed USC researchers and leverage our next-generation sequencing capabilities to help develop this potential treatment for COVID-19,” Hsieh said. “We believe that by using our [next-generation sequencing] With our expertise and knowledge of the evolution and treatment of COVID-19 in China, we have provided relevant and actionable data to the development of XFBD.

Clinical trial sets the stage for better understanding of traditional medicine

The clinical trial is a pilot study conducted entirely remotely, including obtaining informed consent from patients and monitoring patient performance. The resulting data produced will support the design of future XFBD studies.

During the 12-week study, patients are randomly assigned to one of two groups: one receiving XFBD and the other receiving a placebo. Patients take the drug or placebo dissolved in water by mouth twice a day for 14 days, and the clinical trial team using remote patient management software will follow them 10 weeks later to assess their symptoms and performance.

If the pilot study shows that XFBD is safe and remote trial is feasible, researchers can move on to phase II studies, which will involve a larger group of patients as well as specific subgroups of patients, such as specific age and ethnic groups. If these studies go well, phase III studies will follow to demonstrate clinical efficacy.

Ultimately, the researchers hope to see if XFBD will reduce the risk of progression to severe disease, hospitalization and death in people with COVID-19.

For more information on the study, see http://kuhn.usc.edu/xfbd.