Covid19Phase 2NCT04810689
Pilot Trial of XFBD, a TCM, in Persons With COVID-19
A Phase 2 study testing Xuanfei Baidu Granules in people with Covid19, run by Darcy Spicer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid19
- What is being tested?
- Xuanfei Baidu Granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 20 Jun 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
- Able to speak and communicate in English, Spanish, Mandarin Chinese or Cantonese.
Who cannot join
- 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:
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- 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
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Has known prior kidney disease.
- Has known cirrhosis, acute liver disease or uncontrolled chronic liver disease.
- Has known severe coronary artery disease.
- Has known narrow angle glaucoma.
- Has greater than two or a single uncontrolled underlying comorbid condition including cardiovascular disease (coronary artery disease, heart failure, valvular heart disease), hypertension, diabetes, chronic lung disease, chronic kidney disease, chronic liver disease, immunocompromised (HIV or daily users of more than 5 mg/day of prednisone), prior organ transplant.
- Fulfills the FDA EUA criteria of at high risk for progressing to severe COVID-19. This includes high-risk individuals specified in the EUA who meet at least one of the following criteria: Body mass index (BMI) ≥35; Chronic kidney disease; Diabetes mellitus; Immunocompromising condition/immunosuppressive disease; Currently receiving immunosuppressive treatment; Aged ≥65 years; or Aged ≥55 years and have: Cardiovascular disease, or Hypertension, or Chronic obstructive pulmonary disease/other chronic respiratory disease. If the patient is not able to receive the EUA agent casirivimab and imdevimab (Regeneron) or bamlanivimab (Eli Lilly) because of unavailability this exclusion may be waived.
- Women who are currently pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
Official title: A Randomized, Double-Blind, Placebo-Control Pilot Trial of Xuanfei Baidu Granules (XFBD), a Traditional Chinese Medicine (TCM), in Persons With COVID-19
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.
Read the detailed description
Xuanfei Baidu granules (XFBD) is a 13 medicinal traditional Chinese medicine (TCM) prescription developed by Dr. Zhang Boli, a member of Chinese Academy of Engineering, and his team, and used in Wuhan, China, during the initial outbreak of SARS-CoV2. Based on TCM theory, the 13 medicinals used mainly consist of heat-clearing and toxin-removing medicinals to reduce fever and clear viruses; cough-suppressing and phlegm-transforming medicinals to thin and clear the phlegm; and lung-diffusing and pant-calming to soothe the tracheal smooth muscle and relieve shortness of breath. Another unique quality is one of the medicinals helps to dissipate stasis and dissolves blood clots, providing a mild anticoagulant effect.
Before the widespread usage of TCM, nationwide China saw a progression of disease of about 10% of their mild and moderate cases while during the period with the TCM utilization, the percentage dropped to 2-5% depending on the hospital. Overall, they saw an improvement of clinical symptoms. Due to the challenges of the rapidly evolving outbreak, these are clinical observations and not evidence from a controlled study.
The purpose of this initial pilot study is to document the safety of taking a TCM in patients with COVID-19 and to gain information to determine whether a study with TCM can be conducted in the US. The study will test a TCM which has been made into a granule formulation called XFBD.
This is a randomized double-blind placebo-control pilot trial to document safety and efficacy endpoint assessments and to determine the feasibility of community recruitment and enrollment of symptomatic adult outpatients with COVID-19. The 12-week pilot will have 14 days where they receive XFBD or a placebo, orally twice a day and a 10 week follow up. The study will have a total of 60 participants with approximately 30 participants in each treatment arm. The participants will be randomized 1:1 individuals.
- Conditions
- Covid19
- Being tested
- Xuanfei Baidu Granules, Placebo
- Keywords
- Covid19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xuanfei Baidu GranulesDrug
Also called XFBD
Xuanfei Baidu granules is a prescription of 13 herbal medicinals made into dissolvable granules for oral intake
PlaceboOther
Placebo for Xuanfei Baidu granule made into dissolvable granules for oral intake
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement to Participate
To document the proportion of patients who agree to participate as measured by enrollment and randomization.
Measured: 15.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Mar 2021
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
Why it stopped: Futile Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participants will be randomized to 1 of 2 arms: XFBD granules or placebo
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Darcy Spicer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Darcy Spicer, University of Southern California
- Investigators
- Darcy V Spicer, MD, Principal investigator, Keck Medicine of USC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810689
- Sponsor's protocol ID
- HS-20-00632
- Status last verified
- Nov 2025
- First submitted
- 17 Mar 2021
- Last updated
- 15 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Control Pilot Trial of Xuanfei Baidu Granules (XFBD), a Traditional Chinese Medicine (TCM), in Persons With COVID-19
- ClinicalTrials.gov ID
- NCT04810689
- Acronym / sponsor ID
- HS-20-00632
- Conditions
- Covid19
- Keywords
- Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futile Enrollment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Darcy SpicerUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Posted 15 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Xuanfei Baidu granules (XFBD) is a 13 medicinal traditional Chinese medicine (TCM) prescription developed by Dr. Zhang Boli, a member of Chinese Academy of Engineering, and his team, and used in Wuhan, China, during the initial outbreak of SARS-CoV2. Based on TCM theory, the 13 medicinals used mainly consist of heat-clearing and toxin-removing medicinals to reduce fever and clear viruses; cough-suppressing and phlegm-transforming medicinals to thin and clear the phlegm; and lung-diffusing and pant-calming to soothe the tracheal smooth muscle and relieve shortness of breath. Another unique quality is one of the medicinals helps to dissipate stasis and dissolves blood clots, providing a mild anticoagulant effect.
Before the widespread usage of TCM, nationwide China saw a progression of disease of about 10% of their mild and moderate cases while during the period with the TCM utilization, the percentage dropped to 2-5% depending on the hospital. Overall, they saw an improvement of clinical symptoms. Due to the challenges of the rapidly evolving outbreak, these are clinical observations and not evidence from a controlled study.
The purpose of this initial pilot study is to document the safety of taking a TCM in patients with COVID-19 and to gain information to determine whether a study with TCM can be conducted in the US. The study will test a TCM which has been made into a granule formulation called XFBD.
This is a randomized double-blind placebo-control pilot trial to document safety and efficacy endpoint assessments and to determine the feasibility of community recruitment and enrollment of symptomatic adult outpatients with COVID-19. The 12-week pilot will have 14 days where they receive XFBD or a placebo, orally twice a day and a 10 week follow up. The study will have a total of 60 participants with approximately 30 participants in each treatment arm. The participants will be randomized 1:1 individuals.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Study participants will be randomized to 1 of 2 arms: XFBD granules or placebo
| Arm | Type | Receives |
|---|---|---|
| XFBD Arm | Experimental | Drug: Xuanfei Baidu GranulesXFBD (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 Arm | Placebo comparator | Other: PlaceboPlacebo (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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- 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.
Key exclusion criteria (23 listed)
- Need for hospitalization.
- Severe or Critical COVID-19:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xuanfei Baidu GranulesAlso: XFBDXuanfei Baidu granules is a prescription of 13 herbal medicinals made into dissolvable granules for oral intake | Drug | XFBD Arm |
| PlaceboPlacebo for Xuanfei Baidu granule made into dissolvable granules for oral intake | Other | Placebo Arm |
Primary outcome
Agreement to Participate
Time frame: 15.5 months
To document the proportion of patients who agree to participate as measured by enrollment and randomization.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darcy V Spicer, MD principal investigator
Keck Medicine of USC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xuanfei Baidu Granules in people with Covid19, run by Darcy Spicer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement to Participate (time frame: 15.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.