COVID-19Phase 3NCT04323332
Traditional Chinese Medicine for Severe COVID-19
A Phase 3 study testing Traditional Chinese Medicine Prescription in people with COVID-19, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
In December 2019, a new type of pneumonia, COVID-2019 outbroke in Wuhan ,China, and currently the infected has been reported in more than at least 75 countries. Patients with severe COVID-19 have rapid disease progression and high mortality rate. Read more about this study
- Who is it for?
- Ages Up to 85 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Traditional Chinese Medicine Prescription
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Mar 2020to Apr 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 Up to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients were diagnosed as severe COVID-19 according to the Coronavirus disease (COVID-19) Treatment Guidance (Six edition)
- Patients received a combined treatment of TCM and conventional therapy, or only conventional therapy.
Who cannot join
- Age >85 years
- After cardiopulmonary resuscitation
- Patients combined with other organ failure or conditions need ICU monitoring and treatment, such as severe liver disease, severe renal dysfunction, upper gastrointestinal hemorrhage, disseminated intravascular coagulation.
- Respiratory failure and need mechanical ventilation
Trial locations and contacts
1 site in 1 country.
China1 site
Hao Li
Beijing, Beijing Municipality, 100091
Hao Li, Prof., 01062835088, xyhplihao1965@126.com
About this study
Official title: A Retrospective Cohort Study to Evaluate the Efficacy and Safety of Traditional Chinese Medicine as an Adjuvant Treatment for Patients With Severe COVID-19
In December 2019, a new type of pneumonia, COVID-2019 outbroke in Wuhan ,China, and currently the infected has been reported in more than at least 75 countries.
Patients with severe COVID-19 have rapid disease progression and high mortality rate. This may attribute to the excessive immune response caused by cytokine storm. Strategies based on anti-virus drugs and treatments against symptoms have now been employed. However, these managements can't effectively treat the lethal lung injury and uncontrolled immune responses, especially in the elderly with severe COVID-19. Traditional Chinese Medicine (TCM), which treats the disease from anther perspective, has achieved satisfactory results. National Health Commission of China released a series of policies to enhance the administration of TCM prescriptions.
This study is aimed to evaluate the efficacy and safety of Traditional Chinese Medicine as an adjuvant treatment for severe COVID-19.
- Conditions
- COVID-19
- Being tested
- Traditional Chinese Medicine Prescription
- Keywords
- COVID-19, Traditional Chinese Medicine, Pneumonia, Coronavirus
- Medical subject headings
- COVID-19, Pneumonia, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese Medicine PrescriptionDrug
Traditional Chinese Medicine Prescriptions have been recommended according to the Guidelines for the treatment of COVID-19 issued by National Health Commission of the PRC.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese Medicine | Experimental | TCM prescription and conventional treatments Receives: Drug: Traditional Chinese Medicine Prescription |
| Control | No intervention | conventional treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay (days)
Measured: First treatment date up to 3 months
Secondary outcomes (15)
Duration (days) of supplemental oxygenation
Measured: First treatment date up to 3 months
CT imaging changes
Measured: First treatment date up to 3 months
Mortality rate
Measured: First treatment date up to 3 months
Time to Clinical Improvement (TTCI)
Measured: First treatment date up to 3 months
The pneumonia severity index scores
The pneumonia severity index is a clinical tool helping in the risk stratification of patients with community-acquired pneumonia. It ranges from 0-395 scores and a higher score indicates higher death risk.
Measured: First treatment date up to 3 months
Time to COVID-19 nucleic acid testing negativity in throat swab
Measured: First treatment date up to 3 months
Blood immune cell count
Changes in leukocyte, neutral, lymphocyte counts and absolute lymphocyte count from baseline
Measured: Baseline, 7 and/ or 14 days
Serum inflammatory markers
Changes in blood interleukin-6, c-reactive protein,SS-A/Ro antibodies and serum ferritin from baseline.
Measured: Baseline, 7 and/ or 14 days
Erythrocyte sedimentation rate
Changes in erythrocyte sedimentation rate from baseline.
Measured: Baseline, 7 and/ or 14 days
Platelet and D-dimer changes
Changes in platelets and D-dimers from baseline.
Measured: Baseline, 7 and/ or 14 days
Creatinine changes
Changes in serum creatinine from baseline.
Measured: Baseline, 7 and/ or 14 days
Muscle enzymes changes
Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.
Measured: Baseline, 7 and/ or 14 days
Usage of antibiotics
Dosing time and amounts of antibiotics；the categories of the antibiotics
Measured: First treatment date up to 3 months
Usage of glucocorticoids
Dosing time and amounts of glucocorticoids
Measured: First treatment date up to 3 months
Frequency of adverse events
Measured: First treatment date up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study startMar 2020 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Hao, Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Hao Li, Professor, Study chair, Xiyuan Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323332
- Sponsor's protocol ID
- 2020XLA015-1
- Status last verified
- Mar 2020
- First submitted
- 8 Mar 2020
- Last updated
- 26 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Study to Evaluate the Efficacy and Safety of Traditional Chinese Medicine as an Adjuvant Treatment for Patients With Severe COVID-19
- ClinicalTrials.gov ID
- NCT04323332
- Acronym / sponsor ID
- 2020XLA015-1
- Conditions
- COVID-19
- Keywords
- COVID-19, Traditional Chinese Medicine, Pneumonia, Coronavirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In December 2019, a new type of pneumonia, COVID-2019 outbroke in Wuhan ,China, and currently the infected has been reported in more than at least 75 countries.
Patients with severe COVID-19 have rapid disease progression and high mortality rate. This may attribute to the excessive immune response caused by cytokine storm. Strategies based on anti-virus drugs and treatments against symptoms have now been employed. However, these managements can't effectively treat the lethal lung injury and uncontrolled immune responses, especially in the elderly with severe COVID-19. Traditional Chinese Medicine (TCM), which treats the disease from anther perspective, has achieved satisfactory results. National Health Commission of China released a series of policies to enhance the administration of TCM prescriptions.
This study is aimed to evaluate the efficacy and safety of Traditional Chinese Medicine as an adjuvant treatment for severe COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine | Experimental | Drug: Traditional Chinese Medicine PrescriptionTCM prescription and conventional treatments |
| Control | No intervention | –conventional treatments |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients were diagnosed as severe COVID-19 according to the Coronavirus disease (COVID-19) Treatment Guidance (Six edition)
- Patients received a combined treatment of TCM and conventional therapy, or only conventional therapy.
Key exclusion criteria (4 listed)
- Age >85 years
- After cardiopulmonary resuscitation
- Patients combined with other organ failure or conditions need ICU monitoring and treatment, such as severe liver disease, severe renal dysfunction, upper gastrointestinal hemorrhage, disseminated intravascular coagulation.
- Respiratory failure and need mechanical ventilation
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 |
|---|---|---|
| Traditional Chinese Medicine PrescriptionTraditional Chinese Medicine Prescriptions have been recommended according to the Guidelines for the treatment of COVID-19 issued by National Health Commission of the PRC. | Drug | Traditional Chinese Medicine |
Primary outcome
Length of hospital stay (days)
Time frame: First treatment date up to 3 months
15 secondary outcomes
Duration (days) of supplemental oxygenation
Time frame: First treatment date up to 3 months
CT imaging changes
Time frame: First treatment date up to 3 months
Mortality rate
Time frame: First treatment date up to 3 months
Time to Clinical Improvement (TTCI)
Time frame: First treatment date up to 3 months
The pneumonia severity index scores
Time frame: First treatment date up to 3 months
Time to COVID-19 nucleic acid testing negativity in throat swab
Time frame: First treatment date up to 3 months
Blood immune cell count
Time frame: Baseline, 7 and/ or 14 days
Serum inflammatory markers
Time frame: Baseline, 7 and/ or 14 days
Erythrocyte sedimentation rate
Time frame: Baseline, 7 and/ or 14 days
Platelet and D-dimer changes
Time frame: Baseline, 7 and/ or 14 days
Creatinine changes
Time frame: Baseline, 7 and/ or 14 days
Muscle enzymes changes
Time frame: Baseline, 7 and/ or 14 days
Usage of antibiotics
Time frame: First treatment date up to 3 months
Usage of glucocorticoids
Time frame: First treatment date up to 3 months
Frequency of adverse events
Time frame: First treatment date up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: Yes
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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.
Hao Li, Professor study chair
Xiyuan Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Traditional Chinese Medicine Prescription in people with COVID-19, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Mar 2020. 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 China. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Li, Professor (+0086-133113382093, xyhplihao1965@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (days) (time frame: First treatment date up to 3 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 26 Mar 2020.