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=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=9 Participants
|
2 Participants
n=32 Participants
|
5 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=9 Participants
|
2 Participants
n=32 Participants
|
2 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
3 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=9 Participants
|
2 Participants
n=32 Participants
|
4 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=9 Participants
|
2 participants
n=32 Participants
|
5 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: 15.5 monthsPopulation: 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place