Trial Outcomes & Findings for Pilot Trial of XFBD, a TCM, in Persons With COVID-19 (NCT NCT04810689)

NCT ID: NCT04810689

Last Updated: 2025-12-15

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: 15.5 months
• Results posted on: 2025-12-15

Participant Flow

Participants were recruited using a COVID-19 registry at the time of testing in Los Angeles County between March 2021 through June 2022. A total 10 individuals consented and 5 were randomized and received study medication. The first participant was enrolled March 2021 and the last participant was enrolled February of 2022. The study was terminated for futility.

Of the 10 subjects who consented 5 were randomized and 5 withdrew before randomization.

Participant milestones

Measure	XFBD Arm 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 Xuanfei Baidu Granules: Xuanfei Baidu granules is a prescription of 13 herbal medicinals made into dissolvable granules for oral intake	Placebo Arm 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 Placebo: Placebo for Xuanfei Baidu granule made into dissolvable granules for oral intake
Overall Study STARTED	3	2
Overall Study COMPLETED	3	1
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	XFBD Arm 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 Xuanfei Baidu Granules: Xuanfei Baidu granules is a prescription of 13 herbal medicinals made into dissolvable granules for oral intake	Placebo Arm 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 Placebo: Placebo for Xuanfei Baidu granule made into dissolvable granules for oral intake
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	XFBD Arm n=3 Participants 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 Xuanfei Baidu Granules: Xuanfei Baidu granules is a prescription of 13 herbal medicinals made into dissolvable granules for oral intake	Placebo Arm n=2 Participants 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 Placebo: Placebo for Xuanfei Baidu granule made into dissolvable granules for oral intake	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=6009 Participants	0 Participants n=42 Participants	0 Participants n=77 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=6009 Participants	2 Participants n=42 Participants	5 Participants n=77 Participants
Age, Categorical >=65 years	0 Participants n=6009 Participants	0 Participants n=42 Participants	0 Participants n=77 Participants
Sex: Female, Male Female	0 Participants n=6009 Participants	2 Participants n=42 Participants	2 Participants n=77 Participants
Sex: Female, Male Male	3 Participants n=6009 Participants	0 Participants n=42 Participants	3 Participants n=77 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6009 Participants	0 Participants n=42 Participants	0 Participants n=77 Participants
Race (NIH/OMB) Asian	1 Participants n=6009 Participants	0 Participants n=42 Participants	1 Participants n=77 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6009 Participants	0 Participants n=42 Participants	0 Participants n=77 Participants
Race (NIH/OMB) Black or African American	0 Participants n=6009 Participants	0 Participants n=42 Participants	0 Participants n=77 Participants
Race (NIH/OMB) White	2 Participants n=6009 Participants	2 Participants n=42 Participants	4 Participants n=77 Participants
Race (NIH/OMB) More than one race	0 Participants n=6009 Participants	0 Participants n=42 Participants	0 Participants n=77 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6009 Participants	0 Participants n=42 Participants	0 Participants n=77 Participants
Region of Enrollment United States	3 participants n=6009 Participants	2 participants n=42 Participants	5 participants n=77 Participants

PRIMARY outcome

Timeframe: 15.5 months

Population: Enrollment insufficient and hence trial terminated.

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

Outcome measures

Measure	Enrolled n=10 Participants Patients who expressed interest in participating and signed the informed consent
Agreement to Participate Randomized into XFBD Arm	3 Participants
Agreement to Participate Randomized into Placebo Arm	2 Participants
Agreement to Participate Did not start study	5 Participants

Adverse Events

XFBD Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	XFBD Arm n=3 participants at risk 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 Xuanfei Baidu Granules: Xuanfei Baidu granules is a prescription of 13 herbal medicinals made into dissolvable granules for oral intake	Placebo Arm n=2 participants at risk 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 Placebo: Placebo for Xuanfei Baidu granule made into dissolvable granules for oral intake
General disorders insomnia	0.00% 0/3 • 1 month	50.0% 1/2 • Number of events 1 • 1 month

Additional Information

Darcy Spicer

USCalifornia

Phone: 3238653904

Email: DSPICER@USC.EDU

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place