COVID-19 (Coronavirus Disease 2019)Phase 2/3NCT07123701
Clinical Study of Tanshinone Capsules Against COVID-19
A Phase 2/3 study testing Tanshinone capsules in people with COVID-19 (Coronavirus Disease 2019), run by Liu Shuwen at 1 site in China.
Trial summary
The variation of SARS-CoV-2 has caused many countries to face the problem of multiple outbreaks. Gene mutations can change the transmicity, pathogenicity, and immunogenicity of the virus. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- COVID-19 (Coronavirus Disease 2019)
- What is being tested?
- Tanshinone capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 Jul 2025
- Phase
- Phase 2/3
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meet the diagnosis of SARS-CoV-2 infection issued by the National Health Commission of the People's Republic of China (Trial Version 10). Based on the etiology or serological test, within 2 days of diagnosis, and meet the following conditions: 1) The Ct values of N gene and ORF gene of 2019-ncov infection were both less than 30 (fluorescence quantitative PCR method, the cut-off value was 40); 2) Mild and/or moderate clinical classification: subjects had at least one or more of the following clinical symptoms of COVID-19 with a symptom score ≥1 at the time of screening, including but not limited to: fever, cough, sore throat, nasal congestion or runny nose, headache, muscle pain, nausea, vomiting, diarrhea, shortness of breath or dyspnea, chills or chills.
- Age of 18-65 years old, both sexes;
- Participants were required to meet one or more of the following criteria: 1) ≤3 days from the first administration of the investigational drug to the positive SARS-CoV-2 virus infection test specimen during the screening period, 2) ≤3 days from the first onset of COVID-19 symptoms to the first administration of the investigational drug;
- Patients voluntarily participated in this study, and they or their legal representatives signed written informed consent and were willing to cooperate with follow-up.
Who cannot join
- Patients at high risk of severe or critical illness and diagnosed as severe or critical illness before entering the study according to the "Diagnosis and Treatment Protocol for novel coronavirus Infection (Trial version 10)";
- Received antiviral treatment before study entry, such as Chinese patent medicine or Chinese medicine formula treatment, Paxlovid, ritonavir tablets, SARS-CoV-2 monoclonal antibody treatment, convalescent plasma of convalescent patients, other clinical trial drugs indicated for COVID-19, etc. (except previous treatment for COVID-19 infection);
- Subjects with known allergy to therapeutic drug tanshinone capsules or allergic constitution (including susceptible to allergic reactions to other drugs);
- Suffering from diseases that seriously affect the immune system, such as human immunodeficiency virus (HIV) infection, or blood system, or splenectomy, organ transplantation, etc.
- Pregnant and lactating women;
- Suspected bacterial, fungal, viral or other infections other than SARS-CoV-2 during the screening period;
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- Patients with bronchopneumonia, chronic lung abscess, chronic cough for more than 8 weeks, chronic pharyngitis with cough and other diseases before entering the study;
- One of the following conditions during the screening period: 1) ALT or AST>1.5 times ULN; 2) eGFR<60mL/min; 3) hemoglobin <8.0g/L, platelet <5000/μL;
- Patients who participated in other clinical trials within the past 3 months;
- Persons not eligible for enrollment at the investigator's discretion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Placebo-controlled Clinical Trial of Tanshinone Capsules in the Treatment of Patients With COVID-19
The variation of SARS-CoV-2 has caused many countries to face the problem of multiple outbreaks. Gene mutations can change the transmicity, pathogenicity, and immunogenicity of the virus. For example, the Omicron variant circulating around the world spreads faster, increases infectivity, and infects a younger population, which in turn affects the efficacy of antiviral drugs or weakens the protective efficiency of vaccines. Therefore, in order to fully respond to the variation of SARS-CoV-2 and possible new coronaviruses in the future, the development of broad-spectrum anti-coronavirus drugs is an urgent clinical need. Tanshinone capsule is a marketed drug, which is made of the lipid-soluble components of the root of Danshen, a traditional Chinese medicine. It is used for anti-bacterial and anti-inflammatory functions, and is used for acne, tonsillitis and furunils. Its clinical use relives the situation of antibiotic resistance and toxicity. Our previous basic research has shown that tanshinone capsules have anti-SARS-CoV-2 activity in vitro and in humanized ACE2 transgenic mice. The use of tanshinone capsules in the treatment of SARS-CoV-2 infection can further broaden the antiviral pharmacological activity of tanshinone capsules and may increase its clinical function as an antiviral drug for the treatment of viral infection. On the one hand, tanshinone capsules are oral traditional Chinese medicine capsules, which have the advantages of low production/transportation cost, high safety and high patient compliance. On the other hand, tanshinone capsules are expected to reduce the level of inflammation in patients and improve the symptoms of COVID-19 while preventing and treating COVID-19 infection. It can meet the major needs of novel coronavirus pneumonia drug research and development to a high degree.
- Conditions
- COVID-19 (Coronavirus Disease 2019)
- Being tested
- Tanshinone capsules
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tanshinone capsulesDrug
Tanshinone capsules were used in this intervention for COVID-19 patients
| Study group | Role | What they receive |
|---|---|---|
| placebo-controlled clinical trial of tanshinone capsules in the treatment of patients with COVID-19 | Experimental | The experimental group was given tanshinone capsule, and the placebo control was given tanshinone capsule placebo, orally administered 3 times a day, 4 capsules/time, 0.25g/ capsule, for 5 days. Receives: Drug: Tanshinone capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative conversion time of nucleic acid in throat swab
The task turned negative when the CT value of ORF1ab gene and N gene was greater than 30
Measured: After the screening period, the first day of dosing was day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Mar 2024
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 (Coronavirus Disease 2019)Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liu Shuwen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu Shuwen, Southern Medical University, China
- Investigators
- guodong G HU, DOCTOR, Principal investigator, Dongguan People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123701
- Sponsor's protocol ID
- Southern MUC
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Gender, age, and bmi
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-controlled Clinical Trial of Tanshinone Capsules in the Treatment of Patients With COVID-19
- ClinicalTrials.gov ID
- NCT07123701
- Acronym / sponsor ID
- Southern MUC
- Conditions
- COVID-19 (Coronavirus Disease 2019)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Liu ShuwenUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 14 Aug 2025 (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.
The variation of SARS-CoV-2 has caused many countries to face the problem of multiple outbreaks. Gene mutations can change the transmicity, pathogenicity, and immunogenicity of the virus. For example, the Omicron variant circulating around the world spreads faster, increases infectivity, and infects a younger population, which in turn affects the efficacy of antiviral drugs or weakens the protective efficiency of vaccines. Therefore, in order to fully respond to the variation of SARS-CoV-2 and possible new coronaviruses in the future, the development of broad-spectrum anti-coronavirus drugs is an urgent clinical need. Tanshinone capsule is a marketed drug, which is made of the lipid-soluble components of the root of Danshen, a traditional Chinese medicine. It is used for anti-bacterial and anti-inflammatory functions, and is used for acne, tonsillitis and furunils. Its clinical use relives the situation of antibiotic resistance and toxicity. Our previous basic research has shown that tanshinone capsules have anti-SARS-CoV-2 activity in vitro and in humanized ACE2 transgenic mice. The use of tanshinone capsules in the treatment of SARS-CoV-2 infection can further broaden the antiviral pharmacological activity of tanshinone capsules and may increase its clinical function as an antiviral drug for the treatment of viral infection. On the one hand, tanshinone capsules are oral traditional Chinese medicine capsules, which have the advantages of low production/transportation cost, high safety and high patient compliance. On the other hand, tanshinone capsules are expected to reduce the level of inflammation in patients and improve the symptoms of COVID-19 while preventing and treating COVID-19 infection. It can meet the major needs of novel coronavirus pneumonia drug research and development to a high degree.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| placebo-controlled clinical trial of tanshinone capsules in the treatment of patients with COVID-19 | Experimental | Drug: Tanshinone capsulesThe experimental group was given tanshinone capsule, and the placebo control was given tanshinone capsule placebo, orally administered 3 times a day, 4 capsules/time, 0.25g/ capsule, for 5 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Meet the diagnosis of SARS-CoV-2 infection issued by the National Health Commission of the People's Republic of China (Trial Version 10). Based on the etiology or serological test, within 2 days of diagnosis, and meet the following conditions: 1) The Ct values of N gene and ORF gene of 2019-ncov infection were both less than 30 (fluorescence quantitative PCR method, the cut-off value was 40); 2) Mild and/or moderate clinical classification: subjects had at least one or more of the following clinical symptoms of COVID-19 with a symptom score ≥1 at the time of screening, including but not limited to: fever, cough, sore throat, nasal congestion or runny nose, headache, muscle pain, nausea, vomiting, diarrhea, shortness of breath or dyspnea, chills or chills.
- Age of 18-65 years old, both sexes;
- Participants were required to meet one or more of the following criteria: 1) ≤3 days from the first administration of the investigational drug to the positive SARS-CoV-2 virus infection test specimen during the screening period, 2) ≤3 days from the first onset of COVID-19 symptoms to the first administration of the investigational drug;
- Patients voluntarily participated in this study, and they or their legal representatives signed written informed consent and were willing to cooperate with follow-up.
Key exclusion criteria (10 listed)
- Patients at high risk of severe or critical illness and diagnosed as severe or critical illness before entering the study according to the "Diagnosis and Treatment Protocol for novel coronavirus Infection (Trial version 10)";
- Received antiviral treatment before study entry, such as Chinese patent medicine or Chinese medicine formula treatment, Paxlovid, ritonavir tablets, SARS-CoV-2 monoclonal antibody treatment, convalescent plasma of convalescent patients, other clinical trial drugs indicated for COVID-19, etc. (except previous treatment for COVID-19 infection);
- Subjects with known allergy to therapeutic drug tanshinone capsules or allergic constitution (including susceptible to allergic reactions to other drugs);
- Suffering from diseases that seriously affect the immune system, such as human immunodeficiency virus (HIV) infection, or blood system, or splenectomy, organ transplantation, etc.
- Pregnant and lactating women;
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 |
|---|---|---|
| Tanshinone capsulesTanshinone capsules were used in this intervention for COVID-19 patients | Drug | placebo-controlled clinical trial of tanshinone capsules in the treatment of patients with COVID-19 |
Primary outcome
Negative conversion time of nucleic acid in throat swab
Time frame: After the screening period, the first day of dosing was day 1
The task turned negative when the CT value of ORF1ab gene and N gene was greater than 30
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 14 Aug 2025.
- Individual participant dataSharing planned: Yes. Gender, age, and bmi
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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.
guodong G HU, DOCTOR principal investigator
Dongguan People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tanshinone capsules in people with COVID-19 (Coronavirus Disease 2019), run by Liu Shuwen 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 10 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 14 Aug 2025. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Negative conversion time of nucleic acid in throat swab (time frame: After the screening period, the first day of dosing was day 1). 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 14 Aug 2025.