Presenter/Author:

QI Elizabeth

Other Author:

N/A

Author Affiliation:

University of Southern California, Convergent Science Institute in Cancer

Keywords:

COVID-19, Xuanfei Baidu Granules (XFBD), Remote Clinical Trial, Remote Monitoring,

Abstract:

In late March of 2020, the United States saw an increase in confirmed SARS-CoV-2 infections as diagnostic kits became available and the public was more aware of COVID-19 symptoms. With the lack of vaccines and antiviral treatments at the time, we looked to strategies implemented in Wuhan, China, such as Xuanfei Baidu granules (XFBD). XFBD is a 13 medicinal traditional Chinese medicine (TCM) prescription developed by Dr. Zhang Boli and his team, and used in Wuhan, China, during the initial outbreak of SARS-CoV2. Before the widespread usage of TCM, China nationwide saw a progression of the disease in about 10% of their mild and moderate cases while during the period with TCM utilization, the percentage dropped to 2-5% depending on the hospital.

As hospitals in the US were at overcapacity, all non-critical COVID-19 patients had little to no guidance or monitoring during their isolation. We devised “A Randomized, Double-Blind, Placebo-Control Pilot Trial of Xuanfei Baidu Granules (XFBD), a Traditional Chinese Medicine (TCM), in Persons with COVID-19” (NCT04810689) to document the safety of taking XFBD in patients with COVID-19 and to determine the feasibility of community recruitment and enrollment of symptomatic adult outpatients with COVID-19 in Los Angeles county.

The pilot trial aimed to enroll 60 participants to take XFBD or a placebo (1:1) for 14 days and then be followed up for an additional 10 weeks from March 2021 to June 2022. With patients in isolation, the pilot trial was conducted completely remote. The enrollment was done over the phone with study coordinators guiding the patient through a digital informed consent and HIPAA release form on an iOS and/or Android phone application called SCORE. The study kit containing the instructions, study agent, and at-home COVID-19 PCR tests was then mailed to the participant. For 14 days, the participants documented daily tongue images, electronic patient-reported outcome (ePRO) surveys, medication compliance, and at-home PCR tests. For the following 10 weeks, the participants submitted weekly ePRO surveys.

The pilot trial was terminated due to futile enrollment from the rapidly changing situation with the vaccinations, therapies, and emerging variants. However, the participants in the study were able to successfully enroll, report symptoms, and follow up in a completely remote framework. While there were various difficulties, the technology for enrolling and monitoring patients through an entirely remote clinical trial using TCM for COVID-19 is possible.

Reference:

Wei, Pei-Fang. Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7). Chinese Medical Journal: May 5, 2020 - Volume 133 - Issue 9 - p 1087-1095 doi: 10.1097/CM9.0000000000000819
Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. Published online February 24, 2020. doi:10.1001/jama.2020.2648

Funding Source:

This work was funded in whole or in part by Fulgent Genetics and Kathy and Richard Leventhal.

Conflict of Interests:

The technologies discussed in this presentation are licensed to Cansera Inc., a digital health company.