search
Back to results

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

Primary Purpose

Covid19

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Xuanfei Baidu Granules
Placebo
Sponsored by
Darcy Spicer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Covid19 focused on measuring Covid19

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • Able to speak and communicate in English, Spanish, Mandarin Chinese or Cantonese.

Exclusion Criteria:

  • 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
  • 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.

Sites / Locations

  • University of Southern California

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

XFBD Arm

Placebo Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Feasibility of recruitment
To document the feasibility of recruitment through community setting by assessment of the number of positive cases identified per week
Participation Rate
To document the proportion of patients who agree to participate as measured by enrollment and randomization.
Side Effects and Safety Profile
To document the treatment emergent side effects and safety profile of the XFBD and placebo
Rate of hospitalization or death
To document the rate of hospitalization or death within 42 days of enrollment in the XFBD and placebo treated groups.

Secondary Outcome Measures

Symptom Severity Score
To document the effect of XFBD on Symptom Severity Score within 28 days of enrollment in the XFBD and placebo treatment.
Study agent compliance
To document the proportion of patients who are compliant taking greater than 90% of the test substance as measured by self-report
Symptom monitoring compliance
To document the proportion of patients who comply with symptom monitoring.
COVID-19 testing compliance
To document the proportion of patients who comply with repeated clinical testing.
Hospital-free days
To document the hospital-free days from enrollment to 42 days (number of days patient not in hospital)
Adverse Events
To document cumulative incidence of serious adverse events, and adverse events leading to early discontinuation of XFBD or placebo.
Grade 3 and 4 adverse events
To document cumulative incidence of grade 3 and 4 adverse events
Viral load
To obtain levels (detectable versus not detectable, and continuous on log10 scale) of SARS-CoV-2 RNA from nasal swabs at approximately days 1, 7 and 14 among a subset

Full Information

First Posted
March 17, 2021
Last Updated
June 20, 2022
Sponsor
Darcy Spicer
search

1. Study Identification

Unique Protocol Identification Number
NCT04810689
Brief Title
Pilot Trial of XFBD, a TCM, in Persons With COVID-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Futile Enrollment
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
June 20, 2022 (Actual)
Study Completion Date
June 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Darcy Spicer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Covid19

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Study participants will be randomized to 1 of 2 arms: XFBD granules or placebo
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
XFBD Arm
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Xuanfei Baidu Granules
Other Intervention Name(s)
XFBD
Intervention Description
Xuanfei Baidu granules is a prescription of 13 herbal medicinals made into dissolvable granules for oral intake
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo for Xuanfei Baidu granule made into dissolvable granules for oral intake
Primary Outcome Measure Information:
Title
Feasibility of recruitment
Description
To document the feasibility of recruitment through community setting by assessment of the number of positive cases identified per week
Time Frame
90 days
Title
Participation Rate
Description
To document the proportion of patients who agree to participate as measured by enrollment and randomization.
Time Frame
90 days
Title
Side Effects and Safety Profile
Description
To document the treatment emergent side effects and safety profile of the XFBD and placebo
Time Frame
up to 90 days after enrollment
Title
Rate of hospitalization or death
Description
To document the rate of hospitalization or death within 42 days of enrollment in the XFBD and placebo treated groups.
Time Frame
up to 42 days after enrollment
Secondary Outcome Measure Information:
Title
Symptom Severity Score
Description
To document the effect of XFBD on Symptom Severity Score within 28 days of enrollment in the XFBD and placebo treatment.
Time Frame
up to 28 days after enrollment
Title
Study agent compliance
Description
To document the proportion of patients who are compliant taking greater than 90% of the test substance as measured by self-report
Time Frame
up to 14 days after enrollment
Title
Symptom monitoring compliance
Description
To document the proportion of patients who comply with symptom monitoring.
Time Frame
up to 90 days after enrollment
Title
COVID-19 testing compliance
Description
To document the proportion of patients who comply with repeated clinical testing.
Time Frame
up to 14 days after enrollment
Title
Hospital-free days
Description
To document the hospital-free days from enrollment to 42 days (number of days patient not in hospital)
Time Frame
up to 42 days after enrollment
Title
Adverse Events
Description
To document cumulative incidence of serious adverse events, and adverse events leading to early discontinuation of XFBD or placebo.
Time Frame
up to 14 days after enrollment
Title
Grade 3 and 4 adverse events
Description
To document cumulative incidence of grade 3 and 4 adverse events
Time Frame
up to 28 days after enrollment
Title
Viral load
Description
To obtain levels (detectable versus not detectable, and continuous on log10 scale) of SARS-CoV-2 RNA from nasal swabs at approximately days 1, 7 and 14 among a subset
Time Frame
up to 14 days after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Able to speak and communicate in English, Spanish, Mandarin Chinese or Cantonese. Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darcy V Spicer, MD
Organizational Affiliation
Keck Medicine of USC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs