Pilot Trial of XFBD, a TCM, in Persons With COVID-19

NCT04810689 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: HS-20-00632
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to document the safety of taking traditional Chinese medicine (TCM) in patients with COVID-19 and to gain information to determine whether a study with TCM can be conducted. The study will test a traditional Chinese medicine that has been made into a granule formulation called Xuanfei Baidu Granules.

Conditions

Covid19

Keywords

Covid19

Outcome Measures

Primary Outcomes (1)

• Agreement to Participate

  To document the proportion of patients who agree to participate as measured by enrollment and randomization.

  15.5 months

Study Arms (2)

XFBD Arm

EXPERIMENTAL

XFBD (administered as 1 packet of granules dissolved in warm water) orally twice daily for 14 day, 1 hour after food in the morning and at night with at least 8 hours in between doses

Drug: Xuanfei Baidu Granules

Placebo Arm

PLACEBO COMPARATOR

Placebo (administered as 1 packet of granules dissolved in warm water) orally twice daily for 14 day, 1 hour after food in the morning and at night with at least 8 hours in between doses

Other: Placebo

Interventions

Xuanfei Baidu Granules DRUG

Xuanfei Baidu granules is a prescription of 13 herbal medicinals made into dissolvable granules for oral intake

Also known as: XFBD

XFBD Arm

Placebo OTHER

Placebo for Xuanfei Baidu granule made into dissolvable granules for oral intake

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant provides informed consent prior to initiation of any study procedures.
• Individual 18 to 75 years of age.
• Documentation of confirmed active SARS-CoV-2 infection, as determined by an FDA authorized molecular test conducted at any US clinic or laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent from any respiratory specimen collected \<96 hours prior to study entry.
• Mild or Moderate COVID-19 experiencing at least one SARS-CoV-2 infection symptom including:
• Mild Covid-19: Symptoms of mild illness with COVID-19 that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath or dyspnea
• Moderate Covid-19:
• Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion
• Presence of clinical signs consistent with moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) \> 93% on room air at sea level, heart rate ≥ 90 beats per minute from a health care encounter within 48 hours.
• Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period up until reaching hospitalization or 28 days, whichever is earliest.
• Agrees to not utilize TCM outside of this study.
• Willing to be randomized to XFBD and placebo control arm for 14 days, and followed up to 12 weeks.
• Willing to comply with the study related questionnaires, procedures and measurements.
• Will to not become pregnant during the 14 days of test substance ingestion using appropriate accepted methods of contraception. Acceptable methods of contraception include: postmenopausal 1 year of amenorrhea and over 50 years of age; prior tubal ligation or hysterectomy; or barrier contraception using condom or diaphragm plus spermicide.
• Able to provide the identity of their health care provider or health system clinical care entry information.
• Able to utilize telephone and telehealth platform to comply with the study related questionnaires, procedures and measurements. Established during the recruitment process.

You may not qualify if:

• Need for hospitalization.
• Severe or Critical COVID-19:
• Severe COVID-19
• Symptoms suggestive of severe systemic illness with COVID-19, which could include any symptom of moderate illness or shortness of breath at rest, or respiratory distress
• Clinical signs indicative of severe systemic illness with COVID-19, respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 beats per minute, SpO2 ≤ 93% on room air at sea level or respiratory PaO2/FiO2 \< 300
• Critical COVID-19 -- Evidence of critical illness, defined by at least one of the following:
• Respiratory failure defined based on resource utilization requiring at least one of the following: Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \> 20 L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation)
• Shock (defined by systolic blood pressure \< 90 mm Hg, or diastolic blood pressure \< 60 mm Hg or requiring vasopressors)
• Multi-organ dysfunction/failure
• Positive SARS-CoV-2 molecular test in the absence of Covid-19 symptoms. However if patients develop symptoms within 14 days of the positive test and fulfill all other enrollment criteria, they are eligible for participation.
• Receiving the following classes of agents found in 5.4.1. Prohibited Medications
• Use of drugs for anti-SARS-CoV-2 treatment including remdesivir, baricitinib, lopinavir/ritonavir fixed dose combination, ribavirin, chloroquine, hydroxychloroquine, and azithromycin, dexamethasone, bamlanivimab, casirivimab plus imdevimab convalescent plasma, or participation in a clinical trial involving any of these drugs whether for treatment or prophylaxis.
• Participating in a study where co-enrollment is not allowed.
• Receipt of a SARS-CoV-2 vaccination prior to study entry.
• Known allergy/sensitivity or any hypersensitivity to components of XFBD

Sponsors & Collaborators

• Darcy Spicer: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

The study failed to enter a sufficient number of subjects for any meaningful analysis and was terminated for futility.

Results Point of Contact

• Title: Darcy Spicer
• Organization: USCalifornia

DSPICER@USC.EDU

3238653904

Study Officials

• Darcy V Spicer, MD

  Keck Medicine of USC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Study participants will be randomized to 1 of 2 arms: XFBD granules or placebo

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 23, 2021
• Study Start: March 1, 2021
• Primary Completion: June 20, 2022
• Study Completion: June 20, 2022
• Last Updated: December 15, 2025
• Results First Posted: December 15, 2025

Record last verified: 2025-11

Locations

US (1)