Novel Coronavirus PneumoniaPhase 3NCT05305456
Clinical Trial Scheme of Tanreqing Capsules in the Treatment of COVID-19
A Phase 3 study testing Tanreqing capsule and Tanreqing capsule simulator in people with Novel Coronavirus Pneumonia, run by Jiangsu Famous Medical Technology Co., Ltd. at 2 sites in China.
Trial summary
This study was conducted in a randomized, double-blind, placebo-controlled, multicenter clinical trial design. Two groups were designed, the experimental group and the placebo control group. Patients in both groups received basic treatment with vitamin C effervescent tablets. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Novel Coronavirus Pneumonia
- What is being tested?
- Tanreqing capsule and Tanreqing capsule simulator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 2 sitesChina
- Study dates
- 28 Mar 2022to 31 Aug 2022
- 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
- According to the Diagnosis and Treatment Plan for Pneumonia Infected by novel coronavirus (Trial Version 9), those who are in line with the diagnosis of novel coronavirus pneumonia and whose clinical classification is light and ordinary；
- Aged greater than 18, with no gender limitation;
- Symptom score greater than or equal 3 points;
- Voluntarily accept the drug treatment and sign the informed consent.
Who cannot join
- Patients with severe primary respiratory diseases or other pathogenic microbial pneumonia that needs to be differentiated from COVID-19;
- immune deficiency disease, or use of immunosuppressants or glucocorticoids in the last 3 months;
- pregnant and lactating women;
- People with allergic constitution (allergic to more than two drugs or food or known allergic to the drug used in this study);
- mentally ill persons or persons without self-awareness;
- Patients whose expected survival time from screening is not more than 48 hours; (7) those who have been intubated or mechanically ventilated at the time of screening;
- In patients with serious primary diseases of heart, brain, liver and kidney, ALT and AST were 1.5 times higher than the upper limit of normal value; (9) Other conditions that the investigator considers inappropriate for clinical trial participation.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 200093
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial of Tanreqing Capsule Efficacy and Safety in the Treatment of COVID-19 (Mild and Common Type)
This study was conducted in a randomized, double-blind, placebo-controlled, multicenter clinical trial design. Two groups were designed, the experimental group and the placebo control group. Patients in both groups received basic treatment with vitamin C effervescent tablets. Tanreqing capsule was added to basic treatment in the experimental group, and placebo was added to basic treatment in the control group. The treatment course was 7 days, and the observation period was set to 7 days, with a daily visit.
Read the detailed description
The purpose of this study was to evaluate the efficacy and safety of Tanreqing capsule in the treatment of mild and common COVID-19. The trial was a randomized, double-blind, placebo-controlled, multicenter clinical trial design. A total of 480 patients were divided into 2 groups: experimental group and control group 3:1. Patients in both groups received basic treatment with vitamin C effervescent tablets. Tanreqing capsule was added to basic treatment in the experimental group, and placebo was added to basic treatment in the control group. The treatment course was 7 days, and the observation period was set to 7 days, with a daily visit.
- Conditions
- Novel Coronavirus Pneumonia
- Being tested
- Tanreqing capsule, Tanreqing capsule simulator
- Keywords
- mild, common
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tanreqing capsuleDrug
Also called Basic treatment: Vitamin C effervescent tablet, 1g, once a day, warm boiled water after brewing, continuous administration for 7 days.
3 capsules per time, 3 times a day
Tanreqing capsule simulatorDrug
Also called Basic treatment: Vitamin C effervescent tablet, 1g, once a day, warm boiled water after brewing, continuous administration for 7 days.
3 capsules per time, 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| Tanreqing capsule | Experimental | 3 capsules per time, 3 times a day，7 days of treatment Receives: Drug: Tanreqing capsule |
| Tanreqing capsule simulator | Placebo comparator | 3 capsules per time, 3 times a day，7 days of treatment Receives: Drug: Tanreqing capsule simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time from the first dose to sustained clinical recovery
Symptom domains and minors disappear completely within 7 days treatment period after randomization, and maintain it for 2 days without recurrence and the disease don't aggravate
Measured: 8 days
Secondary outcomes (5)
Novel coronavirus N and ORF gene changes
Nucleic acid detection was performed on the 0, 1, 2, 3, 4, 5, 6 and 7 days respectively.
The fluorescent quantitative PCR method was used to determine the Ct value of N gene and ORF gene in novel coronavirus nucleic acid detection. Negative: no Ct value or Ct value>40. Positive: Ct value<35. Ct value (cycle threshold) refers to the Ct value of nucleic acid detection, that is, the number of cycles required when the pcr fluorescence signal reaches the threshold.
Measured: 8 days
The time from the first dose/first testing positive of virus to testing sustained negative of virus within 7 days treatment period after randomization
Testing sustained negative of virus was defined two consecutive (at least 24 hours apart) nasal swabs with new coronavirus nucleic acid detection CT values 35 ,and the negative event date was defined by first negative occurrence.
Measured: 8 days
Effective rate of wind heat attacking lung syndrome
The time from the first dose to sustained clinical improvement defined total scores for symptom domains and minors was <3 within 7 days treatment period after randomization.
Measured: 8 days
Duration of disappearance of main symptoms of wind heat attacking lung syndrome
The time from the first dose to sustained complete disappearance within 7 days treatment period after randomization for every symptom domain, and these two outcomes definition were similar to the primary outcome.
Measured: 8 days
Weight conversion rate (ratio of light type to ordinary type and ordinary type to heavy type)
Proportion of patient experiencing progression to severe illness diagnosed by Trial draft version 9 of Diagnosis and Treatment Protocol for novel Coronavirus pneumonia within 7 days treatment period after randomization, during period from the end of 7 days treatment period to discharged from hospital and 3-month follow-up period after discharge.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start28 Mar 2022
- Primary completion2 Jun 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Novel Coronavirus PneumoniaStudies 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, Investigator, Outcomes assessor
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ruijin Hospital
- Responsible party
- Sponsor
- Investigators
- Zhao Ren, PhD, Principal investigator, Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine (North Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305456
- Sponsor's protocol ID
- FM-P8-2022032501
- Status last verified
- Nov 2022
- First submitted
- 30 Mar 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial of Tanreqing Capsule Efficacy and Safety in the Treatment of COVID-19 (Mild and Common Type)
- ClinicalTrials.gov ID
- NCT05305456
- Acronym / sponsor ID
- FM-P8-2022032501
- Conditions
- Novel Coronavirus Pneumonia
- Keywords
- mild, common
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Ruijin Hospital
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 31 Mar 2022 (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 was conducted in a randomized, double-blind, placebo-controlled, multicenter clinical trial design. Two groups were designed, the experimental group and the placebo control group. Patients in both groups received basic treatment with vitamin C effervescent tablets. Tanreqing capsule was added to basic treatment in the experimental group, and placebo was added to basic treatment in the control group. The treatment course was 7 days, and the observation period was set to 7 days, with a daily visit.
Detailed description
The purpose of this study was to evaluate the efficacy and safety of Tanreqing capsule in the treatment of mild and common COVID-19. The trial was a randomized, double-blind, placebo-controlled, multicenter clinical trial design. A total of 480 patients were divided into 2 groups: experimental group and control group 3:1. Patients in both groups received basic treatment with vitamin C effervescent tablets. Tanreqing capsule was added to basic treatment in the experimental group, and placebo was added to basic treatment in the control group. The treatment course was 7 days, and the observation period was set to 7 days, with a daily visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tanreqing capsule | Experimental | Drug: Tanreqing capsule3 capsules per time, 3 times a day，7 days of treatment |
| Tanreqing capsule simulator | Placebo comparator | Drug: Tanreqing capsule simulator3 capsules per time, 3 times a day，7 days of treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- According to the Diagnosis and Treatment Plan for Pneumonia Infected by novel coronavirus (Trial Version 9), those who are in line with the diagnosis of novel coronavirus pneumonia and whose clinical classification is light and ordinary；
- Aged greater than 18, with no gender limitation;
- Symptom score greater than or equal 3 points;
- Voluntarily accept the drug treatment and sign the informed consent.
Key exclusion criteria (7 listed)
- Patients with severe primary respiratory diseases or other pathogenic microbial pneumonia that needs to be differentiated from COVID-19;
- immune deficiency disease, or use of immunosuppressants or glucocorticoids in the last 3 months;
- pregnant and lactating women;
- People with allergic constitution (allergic to more than two drugs or food or known allergic to the drug used in this study);
- mentally ill persons or persons without self-awareness;
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 |
|---|---|---|
| Tanreqing capsuleAlso: Basic treatment: Vitamin C effervescent tablet, 1g, once a day, warm boiled water after brewing, continuous administration for 7 days.3 capsules per time, 3 times a day | Drug | Tanreqing capsule |
| Tanreqing capsule simulatorAlso: Basic treatment: Vitamin C effervescent tablet, 1g, once a day, warm boiled water after brewing, continuous administration for 7 days.3 capsules per time, 3 times a day | Drug | Tanreqing capsule simulator |
Primary outcome
The time from the first dose to sustained clinical recovery
Time frame: 8 days
Symptom domains and minors disappear completely within 7 days treatment period after randomization, and maintain it for 2 days without recurrence and the disease don't aggravate
5 secondary outcomes
Novel coronavirus N and ORF gene changes
Time frame: 8 days
The time from the first dose/first testing positive of virus to testing sustained negative of virus within 7 days treatment period after randomization
Time frame: 8 days
Effective rate of wind heat attacking lung syndrome
Time frame: 8 days
Duration of disappearance of main symptoms of wind heat attacking lung syndrome
Time frame: 8 days
Weight conversion rate (ratio of light type to ordinary type and ordinary type to heavy type)
Time frame: 90 days
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 6 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
Zhao Ren, PhD principal investigator
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine (North Hospital)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tanreqing capsule and Tanreqing capsule simulator in people with Novel Coronavirus Pneumonia, run by Jiangsu Famous Medical Technology Co., Ltd. at 2 sites 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 7 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 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The time from the first dose to sustained clinical recovery (time frame: 8 days). 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 6 Dec 2022.