Severe COVID-19Phase 3COVID-19NCT06714032
Effect of Traditional Chinese Medicine of Severe COVID-19
A Phase 3 study testing TCM plus conventional drug in people with Severe COVID-19, run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study evaluated the effect of integrated traditional Chinese and Western medicine in the treatment of Severe COVID-19. The patients were randomly divided into experimental group and control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe COVID-19
- What is being tested?
- TCM plus conventional drug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 29 Jan 2023to 25 Jan 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- accord with the diagnosis of severe/critical novel coronavirus infection;
- Age > 18 years old;
- TCM syndrome differentiation diagnosis by the attending physician or above or two attending physicians for diagnosis and consensus;
- Sign the informed consent form.
Who cannot join
- Pregnant and lactating women;
- Trauma, hematological malignancies, various solid tumors and obstetric complications;
- Dementia, various mental patients and those who are unwilling to cooperate;
- The patient is expected to die within the next 24 hours;
- Combined with neuromuscular diseases affecting respiratory and motor functions;
- people who have been bedridden for a long time for various reasons;
- Clinical trial participants who are taking part in other intervention measures;
- Those who are known to be allergic to the therapeutic drugs in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, 450000
About this study
Official title: Integrated Traditional Chinese and Conventional Medicine in Treatment for Patients with Severe COVID-19: Study Protocol for a Randomized Controlled Trial
This study evaluated the effect of integrated traditional Chinese and Western medicine in the treatment of Severe COVID-19. The patients were randomly divided into experimental group and control group.
Read the detailed description
In this study, a multi center randomized controlled trial design was adopted, and the subjects were randomly divided into the experimental group and the control group. The control group was treated with western medicine conventional treatment plus traditional Chinese medicine decoction simulant, while the experimental group was treated with traditional Chinese medicine syndrome differentiation treatment decoction. The course of treatment was 14 days and the patients were followed up for 3 months. The clinical effect of integrated traditional Chinese and Western medicine treatment was evaluated from the aspects of 28 day mortality, 28 days without invasive mechanical ventilation, invasive mechanical ventilation rate, 28 days without ICU stay, clinical stability time, length of hospital stay, quality of life, SOFA score, etc., to clarify the clinical efficacy of integrated traditional Chinese and Western medicine treatment for Severe COVID-19 infection.
- Conditions
- Severe COVID-19
- Being tested
- TCM plus conventional drug, TCM placebo plus conventional drug
- Keywords
- Traditional Chinese Medicine, Severe COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCM plus conventional drugDrug
All patients were treated according to international guidelines. The Experimental group will receive TCM according to the TCM syndrome.
TCM placebo plus conventional drugDrug
All patients were treated according to international guidelines. The control group will receive TCM placebo according to the TCM syndrome.
| Study group | Role | What they receive |
|---|---|---|
| TCM plus conventional drug | Experimental | The experimental group will receive three type of TCM inaddition conventional drug Receives: Drug: TCM plus conventional drug |
| TCM placebo plus conventional drug | Placebo comparator | The control group will receive three type of placebo TCM inaddition conventional drug Receives: Drug: TCM placebo plus conventional drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
Proportion of patients who died of disease on day 28
Measured: Mortality on the 28th day of treatment
Secondary outcomes (9)
Days without invasive mechanical ventilation
Days without invasive mechanical ventilation in 28 days
Measured: the 28 days of the treatment phase
invasive mechanical ventilation rate
Rate of patients receiving invasive mechanical ventilation
Measured: 28 days in the treatment phase
days of non-ICU
Calculate the number of days of patients not staying in ICU within 28 days
Measured: 28 days in the treatment phase
time to clinical stability
temperature of 37.2°C orlower, heart rate of 100 beats/min or lower, systolic blood pressure of 90 mm Hg or higher, and arterial oxygen tension of 60 mm Hg or higher when the patient was not receiving supplemental oxygen.
Measured: every day in the treatment.
hospitalization time
length of hospital stays will be recorded.
Measured: the 28 days of the treatment phase
Clinical status of patients 15 days after randomization
According to the 6-point clinical improvement scale of the World Health Organization, the lowest score was 1 and the highest was 6. The higher the score, the worse the result.
Measured: The clinical status of patients was observed 15 days after randomization.
Quality of life
Score according to the quality of life table,the minimum score is 12 points, and the maximum score is 60 points. The higher the score, the worse the result.
Measured: The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted.
TCM syndrome score
Traditional Chinese Medicine Syndrome Points.Including cough, expectoration, dyspnea, chest pain, anorexia and fatigue, each item is rated as 1-5 points from mild to severe.The minimum score is 6 points and the maximum score is 30 points. The higher the score, the worse the result.
Measured: The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted.
SOFA score
Sequential Organ Failure Assessment.It is a scoring system for evaluating and monitoring the organ function of critically ill patients.The minimum score is 0 and the maximum is 24. The higher the score, the worse the result.
Measured: The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start29 Jan 2023
- Primary completion8 Nov 2023
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714032
- Sponsor's protocol ID
- TCM for Severe COVID-19
- Acronym
- COVID-19
- Status last verified
- Dec 2024
- First submitted
- 26 Oct 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Traditional Chinese and Conventional Medicine in Treatment for Patients with Severe COVID-19: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06714032
- Acronym / sponsor ID
- COVID-19 / TCM for Severe COVID-19
- Conditions
- Severe COVID-19
- Keywords
- Traditional Chinese Medicine, Severe COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 29 Jan 2023 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 3 Dec 2024 (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.
This study evaluated the effect of integrated traditional Chinese and Western medicine in the treatment of Severe COVID-19. The patients were randomly divided into experimental group and control group.
Detailed description
In this study, a multi center randomized controlled trial design was adopted, and the subjects were randomly divided into the experimental group and the control group. The control group was treated with western medicine conventional treatment plus traditional Chinese medicine decoction simulant, while the experimental group was treated with traditional Chinese medicine syndrome differentiation treatment decoction. The course of treatment was 14 days and the patients were followed up for 3 months. The clinical effect of integrated traditional Chinese and Western medicine treatment was evaluated from the aspects of 28 day mortality, 28 days without invasive mechanical ventilation, invasive mechanical ventilation rate, 28 days without ICU stay, clinical stability time, length of hospital stay, quality of life, SOFA score, etc., to clarify the clinical efficacy of integrated traditional Chinese and Western medicine treatment for Severe COVID-19 infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM plus conventional drug | Experimental | Drug: TCM plus conventional drugThe experimental group will receive three type of TCM inaddition conventional drug |
| TCM placebo plus conventional drug | Placebo comparator | Drug: TCM placebo plus conventional drugThe control group will receive three type of placebo TCM inaddition conventional drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- accord with the diagnosis of severe/critical novel coronavirus infection;
- Age > 18 years old;
- TCM syndrome differentiation diagnosis by the attending physician or above or two attending physicians for diagnosis and consensus;
- Sign the informed consent form.
Key exclusion criteria (8 listed)
- Pregnant and lactating women;
- Trauma, hematological malignancies, various solid tumors and obstetric complications;
- Dementia, various mental patients and those who are unwilling to cooperate;
- The patient is expected to die within the next 24 hours;
- Combined with neuromuscular diseases affecting respiratory and motor functions;
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 |
|---|---|---|
| TCM plus conventional drugAll patients were treated according to international guidelines. The Experimental group will receive TCM according to the TCM syndrome. | Drug | TCM plus conventional drug |
| TCM placebo plus conventional drugAll patients were treated according to international guidelines. The control group will receive TCM placebo according to the TCM syndrome. | Drug | TCM placebo plus conventional drug |
Primary outcome
28-day mortality
Time frame: Mortality on the 28th day of treatment
Proportion of patients who died of disease on day 28
9 secondary outcomes
Days without invasive mechanical ventilation
Time frame: the 28 days of the treatment phase
invasive mechanical ventilation rate
Time frame: 28 days in the treatment phase
days of non-ICU
Time frame: 28 days in the treatment phase
time to clinical stability
Time frame: every day in the treatment.
hospitalization time
Time frame: the 28 days of the treatment phase
Clinical status of patients 15 days after randomization
Time frame: The clinical status of patients was observed 15 days after randomization.
Quality of life
Time frame: The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted.
TCM syndrome score
Time frame: The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted.
SOFA score
Time frame: The scores on the 1st, 4th, 7th, 14th, 21st and 28th day of admission were counted
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 TCM plus conventional drug in people with Severe COVID-19, run by Henan University of Traditional Chinese Medicine 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 3 Dec 2024. 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. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
28-day mortality (time frame: Mortality on the 28th day of treatment). 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 3 Dec 2024.