COVID-19Phase 4NCT05697029
Tetrandrine Tablets Used in Hospitalized Adults With COVID-19
A Phase 4 study testing Tetrandrine in people with COVID-19, run by Peking University Third Hospital at 1 site in China.
Trial summary
The primary objective of this study is to evaluate the effectiveness of tetrandrine tablets in preventing the progression of COVID-19 from severe to critical. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Tetrandrine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2023to 12 Dec 2025
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign informed consent form voluntarily for the trial.
- Male or female aged between 18 and 85 years (inclusive).
- Clinically or laboratory confirmed COVID-19 within the past 7 days, as determined by a positive RT-PCR test or a positive antigen test.
- Under resting conditions, oxygen saturation ≤93% when breathing air, or P/F value ≤ 300 mmHg (1 mmHg = 0.133 kPa).
- No birth plan and must agree to take effective contraceptive methods.
Who cannot join
- Received a vaccine within 4 weeks prior to the study, or plan to receive a vaccine during the study period, or received treatment with tetrandrine tables prior to enrolling in the study.
- Patient must be on invasive mechanical ventilation/ECMO at baseline.
- Any clinically important serious diseases unstable or uncontrolled.
- Allergy history to any biological or other agent.
- Patient has severe mental or psychological abnormalities, cognitive impairment or intellectual disability before being diagnosed with COVID-19.
- Subjects who are pregnant or breastfeeding, or plan to become pregnant during the study.
- Investigator think the subject should not participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: Tetrandrine Tablets Used in Hospitalized Adults With COVID-19: a Double-blind, Placebo-controlled, Randomised Trial
The primary objective of this study is to evaluate the effectiveness of tetrandrine tablets in preventing the progression of COVID-19 from severe to critical.
Read the detailed description
The primary objective of this study is to evaluate the effectiveness of tetrandrine tablets in preventing the progression of COVID-19 from severe to critical. The secondary objective is to evaluate the clinical indicators of COVID-19 with tetrandrine tablets treatment.
- Conditions
- COVID-19
- Being tested
- Tetrandrine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetrandrineDrug
tetrandrine TID for 28 days
| Study group | Role | What they receive |
|---|---|---|
| tetrandrine group | Experimental | Tetrandrine 60mg TID for 28 days Receives: Drug: Tetrandrine |
| placebo group | Placebo comparator | placebo TID for 28 days Receives: Drug: Tetrandrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosed with critical COVID-19 pneumonia
Diagnosed with COVID-19 pneumonia according to the criteria and meeting one of the following conditions: a. respiratory failure requiring mechanical ventilation, b. shock, c. other organ dysfunction requiring ICU management.
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start31 Dec 2023 (estimated)
- Primary completion12 Dec 2025 (estimated)
- Study completion12 Dec 2025 (estimated)
Why it stopped: Due to the lack of funding from the sponsor, the research drug and placebo cannot be obtained.
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.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Yongchang, Peking University Third Hospital
- Investigators
- Yongchang Sun, M.D., Principal investigator, Peking University 3rd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697029
- Sponsor's protocol ID
- M2023002
- Status last verified
- Sep 2024
- First submitted
- 21 Jan 2023
- Last updated
- 1 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tetrandrine Tablets Used in Hospitalized Adults With COVID-19: a Double-blind, Placebo-controlled, Randomised Trial
- ClinicalTrials.gov ID
- NCT05697029
- Acronym / sponsor ID
- M2023002
- Conditions
- COVID-19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the lack of funding from the sponsor, the research drug and placebo cannot be obtained.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 31 Dec 2023 (estimated)
- Primary completion
- 12 Dec 2025 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 25 Jan 2023 (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 primary objective of this study is to evaluate the effectiveness of tetrandrine tablets in preventing the progression of COVID-19 from severe to critical.
Detailed description
The primary objective of this study is to evaluate the effectiveness of tetrandrine tablets in preventing the progression of COVID-19 from severe to critical. The secondary objective is to evaluate the clinical indicators of COVID-19 with tetrandrine tablets treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tetrandrine group | Experimental | Drug: TetrandrineTetrandrine 60mg TID for 28 days |
| placebo group | Placebo comparator | Drug: Tetrandrineplacebo TID for 28 days |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sign informed consent form voluntarily for the trial.
- Male or female aged between 18 and 85 years (inclusive).
- Clinically or laboratory confirmed COVID-19 within the past 7 days, as determined by a positive RT-PCR test or a positive antigen test.
- Under resting conditions, oxygen saturation ≤93% when breathing air, or P/F value ≤ 300 mmHg (1 mmHg = 0.133 kPa).
- No birth plan and must agree to take effective contraceptive methods.
Key exclusion criteria (7 listed)
- Received a vaccine within 4 weeks prior to the study, or plan to receive a vaccine during the study period, or received treatment with tetrandrine tables prior to enrolling in the study.
- Patient must be on invasive mechanical ventilation/ECMO at baseline.
- Any clinically important serious diseases unstable or uncontrolled.
- Allergy history to any biological or other agent.
- Patient has severe mental or psychological abnormalities, cognitive impairment or intellectual disability before being diagnosed with COVID-19.
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 |
|---|---|---|
| Tetrandrinetetrandrine TID for 28 days | Drug | placebo group, tetrandrine group |
Primary outcome
Diagnosed with critical COVID-19 pneumonia
Time frame: 84 days
Diagnosed with COVID-19 pneumonia according to the criteria and meeting one of the following conditions: a. respiratory failure requiring mechanical ventilation, b. shock, c. other organ dysfunction requiring ICU management.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Yongchang Sun, M.D. principal investigator
Peking University 3rd Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tetrandrine in people with COVID-19, run by Peking University Third Hospital 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 5 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: withdrawn, as of the sponsor's last update on 1 Oct 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Diagnosed with critical COVID-19 pneumonia (time frame: 84 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 1 Oct 2024.