Xuanfei Baidu Granules for COVID-19

1
Effectiveness
2
Safety
University of Southern California, Los Angeles, CA
COVID-19+1 More
Xuanfei Baidu Granules - Drug
Eligibility
18+
All Sexes
Eligible conditions
COVID-19

Study Summary

This study is evaluating whether a traditional Chinese medicine may help individuals with chronic obstructive pulmonary disease.

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Eligible Conditions

  • COVID-19
  • Covid19

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Xuanfei Baidu Granules will improve 4 primary outcomes and 8 secondary outcomes in patients with COVID-19. Measurement will happen over the course of up to 90 days after enrollment.

90 days
Feasibility of recruitment
Participation Rate
Day 14
Adverse Events
COVID-19 testing compliance
Study agent compliance
Viral load
Day 28
Grade 3 and 4 adverse events
Symptom Severity Score
Day 42
Hospital-free days
Rate of hospitalization or death
Day 90
Side Effects and Safety Profile
Symptom monitoring compliance

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Placebo Arm
XFBD Arm
Placebo group

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Xuanfei Baidu Granules is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

XFBD Arm
Drug
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 Arm
Other
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

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 90 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 90 days for reporting.

Closest Location

University of Southern California - Los Angeles, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participant provides informed consent prior to initiation of any study procedures.
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.
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 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
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.
Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for covid-19?

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A number of treatments are available for Covid-19, however, they were poorly communicated or inconsistent in their use. Further collaborative research would help with these issues. Copyright © 2020 The Authors. Urologic Oncology, published by Wiley Periodicals, Inc. on behalf of International Commission on Urological Oncology.

Unverified Answer

What are the signs of covid-19?

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Patients with cough must be tested for respiratory illness in an emergency department. A history is an important part of the assessment process for patients with cough to assess for other causes of cough and a diagnosis can facilitate implementation of appropriate patient management. The cough should be quantitatively assessed for number of days of cough and other cough symptoms for cough severity and the number of days of fever.

Unverified Answer

Can covid-19 be cured?

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We found no evidence that this disease can be cured, only that it can be controlled, as most people do not make any long-term clinical or virologic deterioration.

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How many people get covid-19 a year in the United States?

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In the United States, the number of reported infected cases has been relatively consistent. As of May 23, 2019, 11,946 confirmed cases had been reported in the United States (0.16% of all reported cases), which is 1,744 cases less than the peak reported as of May 3, New York City has reported more cases than any other city or state. Many individuals who have developed symptoms or had exposure to an individual who developed symptoms or had exposure to any of the 9 states in the Northeast or Southeast have been hospitalized with symptoms consistent with covid-19, including cases reported as far east as the Carolinas. Since the virus can remain infectious for months or years, additional cases may go unreported.

Unverified Answer

What causes covid-19?

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It is estimated that the age-adjusted ratio of disease to death is 7.7 and the ratio of deaths to morbidity is 0.7. Results from a recent clinical trial underscore that, over time, new virus variants are continually arising and are adapted to and transmitted among hosts. They also shed light on the importance of health systems in protecting the community from potential health care disasters.

Unverified Answer

What is covid-19?

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Covid-19, commonly known as coronavirus disease 2019, has killed close to 2,500 people and caused hundreds more to be sick worldwide as of January 2020. It was declared as a national security concerns by the WHO in Wuhan, China which has since become infected. In the outbreak, over 70% of patients were reported as recovered in China, despite no treatment. This is likely because of a significant proportion of patients having been misdiagnosed as simple pneumonia which is treatable without antivirus drug. Hence, the majority of those with actual infection with the virus don't know their cure.

Unverified Answer

What are the common side effects of xuanfei baidu granules?

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XFBG is generally well-tolerated in clinical practice. However, the most frequent adverse effects were headache (11.6%), and constipation (10.2%). In contrast, the most common side effects of yanzhuang tablets were dizziness (23.4%), fatigue (14% of patients), insomnia (13.8%), headache (13.1%), nausea (11.5%), diarrhea (10.1%), and dyspepsia (1.6%).

Unverified Answer

How serious can covid-19 be?

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There is not always good evidence of clinical syndromes related to current coronaviruses. It seems that for some, the disease may be less severe. At the same time, even these mild and sub-clinical symptoms may be of concern to families and hospitals as the number of cases increases.

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Does xuanfei baidu granules improve quality of life for those with covid-19?

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Xinxue baidu granules may not shorten the course of, or otherwise improve the quality of life of patients with a confirmed diagnosis of covid-19. These data highlight the need for ongoing trials of treatment alternatives and new and better-designed trials for patients with covid-19.

Unverified Answer

Have there been other clinical trials involving xuanfei baidu granules?

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XGBJX has been used in clinical practice for a long time. The studies related to xuanfei baidu granule were limited and did not show much evidence. A study with a larger patient sample was urgently needed.

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Who should consider clinical trials for covid-19?

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The following should be considered by clinicians when evaluating a new treatment for COVID-19: \n- Identifying if COVID-19 has been studied before to determine potential side-effects;\n- Identifying prior treatments that may be useful in limiting the side effects of a particular treatment; and\n- Identifying any comorbidities that may increase the risk of serious complications.\nUsing these factors will help guide clinicians when considering potential clinical trials. [Power.net®] and [PubHealth®] help patients find clinical trials tailored to their conditions, location, and optimal treatments.

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What does xuanfei baidu granules usually treat?

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In summary, xuanfei baidu granules are thought to have a variety of effective therapeutic effects, and can be considered as a new approach for treating SARS-CoV-2 infection.

Unverified Answer
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