Coronavirus Disease 2019NCT04285190
The Effect of T89 on Improving Oxygen Saturation and Clinical Symptoms in Patients With COVID-19
A study testing T89 in people with Coronavirus Disease 2019 and Novel Coronavirus Pneumonia, run by Tasly Pharmaceuticals, Inc..
Trial summary
This is an open-label, randomized, blank-controlled treatment clinical study. The objective of this study is to investigate the effect of T89 on improving oxygen saturation and clinical symptoms in patients with Coronavirus Disease 2019 (COVID-19). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronavirus Disease 2019, Novel Coronavirus Pneumonia
- What is being tested?
- T89
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 26 Feb 2020to 20 Apr 2020
- Phase
- Interventional
- 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
- Adult male or female patients aged 18-85 years old;
- The newly diagnosed COVID-19 patients who meet the diagnostic criteria set forth in the "Guidance of Diagnosis and Treatment for Patients with Coronavirus Disease 2019 (COVID-19) (Procedural Version 5 Amendment)", issued by the National Health Commission of the People's Republic of China on 8 February 2020;
- Patients whose blood oxygen saturation is not less than 90%.
- Patients who agree to participate in the study and voluntarily comply with the relevant requirements of the study.
Who cannot join
- Patients with other diseases that may affect, in the opinion of study researchers, the implementation of the study or the observation of the efficacy data;
- Patients with severe Coronavirus Disease 2019 (COVID-19), that is based on "Guidance of Diagnosis and Treatment for Patients with Coronavirus Disease 2019 (COVID-19) (Procedural Version 5 Amendment)" with respect to the criteria for clinical severity classification;
- Female patients with known pregnancy and in lactation at screening;
- Patients with previous allergies to T89 or Radix Salvia Miltiorrhizae, Radix Notoginseng and Borneol;
- Any other condition that, in the opinion of the investigator, may affect the conduct of the study, reduce compliance or increase the risk of patients.
About this study
Official title: A Clinical Study to Investigate the Effect of T89 on Improving Oxygen Saturation and Clinical Symptoms in Patients With Coronavirus Disease 2019 (COVID-19)
This is an open-label, randomized, blank-controlled treatment clinical study. The objective of this study is to investigate the effect of T89 on improving oxygen saturation and clinical symptoms in patients with Coronavirus Disease 2019 (COVID-19). In this study, estimated total of 120-240 male and female patients who have been diagnosed with non-critical type of coronavirus pneumonia (COVID-19) will be enrolled and randomly assigned to one of two study groups, the T89 treatment group and the blank control group, to T89 or nothing on the base of a recommended standard treatment for up to 14 days . The primary efficacy parameters include the time to oxygen saturation recovery to normal level (≥97%), the proportion of patients with normal level of oxygen saturation after treatment, and the total duration of oxygen inhalation, oxygen flow change by time, oxygen concentration change by time during treatment.
Read the detailed description
The breakout of a new type of coronavirus (SARS-CoV-2) begun in Wuhan of Hubei province in China in December 2019, and as a result of its rapid spreading nationwide, as of February 16, 2020, a large number of people up to 68,500 totally in China were diagnosed with a new type of disease of Coronavirus Disease 2019 (COVID-19) and 1665 peoples were died due to this disease in China. Based on the recent epidemiological investigation, the incubation period of this new coronavirus is 1-14 days and 3-7 days for most people before they show any symptom, such as fever, fatigue and dry cough that are the main clinical symptoms a few patients will also show nasal congestion, runny nose, sore throat and diarrhea and other symptoms. Severe patients often have dyspnea and/or hypoxemia 1 week after onset of the disease, and the rapid progression for these patients include acute respiratory distress syndrome, septic shock, refractory metabolic acidosis and coagulation dysfunction.
According to the "Guidance of Diagnosis and Treatment for Patients with Coronavirus Disease 2019 (COVID-19) (Procedural Version 5 Amendment)" recently issued by National Health Commission of the People's Republic of China, the general treatment will include close monitoring vital signs and oxygen saturation at finger, additionally, monitoring routine blood test, routine urine test, coagulation function, arterial blood gas analysis based on individual condition, and providing effective oxygen inhalation treatment (including nasal catheter, mask oxygen supply and transnasal high flow oxygen therapy) in time.
T89 have the effects of activating blood circulation and removing blood stasis, regulating Qi and relieving pain. Four clinical trials conducted in China and abroad have shown that T89 can effectively alleviate the clinical symptoms of acute high altitude reaction, improve blood oxygen saturation, significantly increase the exercise time in treadmill and metabolic equivalents of task and enhance exercise tolerance under hypoxic environment. Modern pharmacological and gene network-based studies have shown that T89 can improve the oxygen carrying capacity of red blood cells, increase oxygen saturation, effectively reduce the injury of major organs such as heart, brain, lung and kidney caused by hypoxia, and prevent the decrease of oxygen saturation by improving the energy metabolism disorder caused by hypoxia. At the same time, T89 can inhibit the reduction of hematocrit, albumin leakage, neutrophil CD18 and adhesion factor of endothelial cells (ICAM-1), by which T89 has a good therapeutic effect on microcirculation disorders caused by many diseases.
In conclusion, T89 can improve the ability of carrying oxygen of red blood cells, increase the oxygen saturation, effectively reduce the injury of heart, brain, lung and kidney and other major organs caused by hypoxia, and it can significantly improve the microcirculation disorder. At the same time, in the "Guidance for the Diagnosis and Treatment of Infectious Atypical Pneumonia (Severe Acute Respiratory Syndromes, SARS) P (2003 edition)" has also recommended T89 can be used as a traditional Chinese patent medicine to treat patients of advanced stage and severe SARS lung asthma syndrome by its effect of promoting blood circulation and removing blood stasis. In conclusion, T89 can improve the oxygen saturation and the clinical symptoms of patients with Coronavirus Disease 2019 (COVID-19), as a result, there may be some benefits for these patients to use T89 in current clinical treatment.
This exploratory treatment clinical study is to investigate the effect of T89 on improving oxygen saturation and clinical symptoms in patients with Coronavirus Disease 2019 (COVID-19), with the study design characterized by open-label, randomized and blank-control. In this study, an estimated total of 120-240 male and female patients aged 18-85 years old who have been diagnosed with coronavirus pneumonia (COVID-19), not including critical type in severity, will be enrolled and randomly assigned to one of two study groups, the T89 treatment group and the blank control group, to receive T89 or nothing for up to 14 days on the base of a standard treatment recommended by the"Guidance of Diagnosis and Treatment for Patients with Coronavirus Disease 2019 (COVID-19) (Procedural Version 5 Amendment) .
As planned, this study will be started before March 2020 in hospitals located in Wuhan of Hubei province in China and completed at the end of next June 2020.
- Being tested
- T89
- Keywords
- 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.
T89Drug
Also called Dantonic
The subjects in the T89 treatment group will receive 30 pills of T89 orally, bid., for 10 days, except a standard background treatment (antiviral drug + antibacterial + oxygen therapy+ Traditional Chinese Medicine decoction). The subjects in the blank control group will only receive a standard background treatment.
| Study group | Role | What they receive |
|---|---|---|
| The T89 treatment group | Experimental | Besides a standard background treatment (antiviral drug + antibacterial + oxygen therapy + Traditional Chinese Medicine decoction), all subjects in the T89 treatment group will receive 30 pills of T89 each time, orally, BID(every morning and evening), for 10 days (Depending on clinical need and practicability, the use can be extended for up to 14 days). Receives: Drug: T89 |
| The blank control group | No intervention | All subjects in the blank control group will only receive a standard background treatment (antiviral drug + antibacterial + oxygen therapy + Traditional Chinese Medicine decoction), for 10 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to oxygen saturation recovery to normal level (≥97%)
From screening to the end of treatment, for all patients randomized, oxygen saturation will be assessed for 3 times daily, the time to oxygen saturation recovery to normal level (≥97%) will be calculated finally based on that record and compared between two groups.
Measured: Day -1 to 10
The proportion of patients with normal level of oxygen saturation(≥97%)
The proportion of patients with normal level of oxygen saturation(≥97%) after treatment will be calculated finally based on that record and compared between two groups.
Measured: Day -1 to 10
Secondary outcomes (16)
The degree of remission of symptoms of patients, including: fatigue, nausea, vomiting, chest tightness, shortness of breath, etc.
From screening to the end of treatment, for all patients randomized, the symptoms will be assessed 2 times daily, and the time to achievement of remission for each symptom will be calculated finally based on the record and compared between two groups.
Measured: Day -1 to 10
The time to the myocardial enzyme spectrum recovery to normal after treatment
From screening to the end of treatment, for all patients randomized, myocardial enzyme spectrum will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the myocardial enzyme spectrum recovery to normal will be calculated finally based on the record and compared between two groups.
Measured: Day -1, 3, 7 and 10
The proportion of the patients with normal myocardial enzyme spectrum after treatment
From screening to the end of treatment, for all patients randomized, myocardial enzyme spectrum will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal myocardial enzyme spectrum after treatment will be calculated finally based on the record and compared between two groups.
Measured: Day -1, 3, 7 and 10
The time to the electrocardiogram recovery to normal level after treatment
From screening to the end of treatment, for all patients randomized, 12-lead electrocardiogram will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the myocardial enzyme spectrum recovery to normal level will be calculated finally based on the record and compared between two groups.
Measured: Day -1, 3, 7 and 10
The proportion of the patients with normal electrocardiogram after treatment
From screening to the end of treatment, for all patients randomized, 12-lead electrocardiogram will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal electrocardiogram will be calculated finally based on the record and compared between two groups.
Measured: Day -1, 3, 7 and 10
The time to the hemodynamics recovery to normal after treatment
From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The time to the hemodynamics recovery to normal will be calculated finally based on the record and compared between two groups.
Measured: Day -1 and 10
The proportion of the patients with normal hemodynamics after treatment
From screening to the end of treatment, for all patients randomized, the hemodynamics will be assessed on Day -1, Day 3, 7 and 10 post treatment. The proportion with normal hemodynamics will be calculated finally based on the record and compared between two groups.
Measured: Day -1 and 10
The time to exacerbation or remission of the disease after treatment;
From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The time to exacerbation or remission of the disease will be calculated finally based on the record and compared between two groups.
Measured: Day -1 to 10
The proportion of the patients with exacerbation or remission of disease after treatment
From screening to the end of treatment, for all patients randomized, the clinical severity will be assessed 1 time daily. The proportion of patients whose disease get aggravated or alleviated will be calculated finally based on the record and compared between two groups.
Measured: Day -1 to 10
The proportion of patients who need other treatment (e.g. heparin, anticoagulants) due to microcirculation disorders
From screening to the end of treatment, for all patients randomized, the need for additional treatment will be recorded and compared between two groups.
Measured: Day -1 to 10
The all-cause mortality rate
For all patients, the mortality will be recorded in each group and the rate will be compared between two groups.
Measured: Day -1 to 10
The proportion of patients with acidosis
From screening to the end of treatment, for all patients randomized, the proportion of patients with acidosis will be compared between two groups based on the hemodynamics results.
Measured: Day -1 and 10
The total duration of the patients in-hospital
For all patients, the duration of hospitalization will be recorded in each group and compared between two groups.
Measured: Day -1 to 10
The total duration of oxygen inhalation during treatment
From screening to the end of treatment, for all patients randomized, the total duration of oxygen inhalation during oxygen treatment will be assessed and compared, if applicable, between two groups.
Measured: Day -1 to 10
The oxygen flow rate during treatment
From screening to the end of treatment, for all patients randomized, the oxygen flow rate during oxygen treatment will be assessed and compared, if applicable, between two groups.
Measured: Day -1 to 10
The oxygen concentration during treatment
From screening to the end of treatment, for all patients randomized, the oxygen concentration during oxygen treatment will be assessed and compared, if applicable, between two groups.
Measured: Day -1 to 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start26 Feb 2020
- Primary completion15 Apr 2020
- Study completion20 Apr 2020
Why it stopped: The COVID-19 pandemic in China has ended completely. As a result, patient recruiting is impossible in China.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An open-label, randomized, blank-controlled treatment clinical study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shuiping Zhou, PhD, Study chair, Tasly Pharmaceutical Group Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285190
- Sponsor's protocol ID
- T89-NCP-01
- Status last verified
- Mar 2020
- First submitted
- 19 Feb 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Investigate the Effect of T89 on Improving Oxygen Saturation and Clinical Symptoms in Patients With Coronavirus Disease 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT04285190
- Acronym / sponsor ID
- T89-NCP-01
- Keywords
- COVID-19
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The COVID-19 pandemic in China has ended completely. As a result, patient recruiting is impossible in China.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tasly Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 26 Feb 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.
This is an open-label, randomized, blank-controlled treatment clinical study. The objective of this study is to investigate the effect of T89 on improving oxygen saturation and clinical symptoms in patients with Coronavirus Disease 2019 (COVID-19). In this study, estimated total of 120-240 male and female patients who have been diagnosed with non-critical type of coronavirus pneumonia (COVID-19) will be enrolled and randomly assigned to one of two study groups, the T89 treatment group and the blank control group, to T89 or nothing on the base of a recommended standard treatment for up to 14 days . The primary efficacy parameters include the time to oxygen saturation recovery to normal level (≥97%), the proportion of patients with normal level of oxygen saturation after treatment, and the total duration of oxygen inhalation, oxygen flow change by time, oxygen concentration change by time during treatment.
Detailed description
The breakout of a new type of coronavirus (SARS-CoV-2) begun in Wuhan of Hubei province in China in December 2019, and as a result of its rapid spreading nationwide, as of February 16, 2020, a large number of people up to 68,500 totally in China were diagnosed with a new type of disease of Coronavirus Disease 2019 (COVID-19) and 1665 peoples were died due to this disease in China. Based on the recent epidemiological investigation, the incubation period of this new coronavirus is 1-14 days and 3-7 days for most people before they show any symptom, such as fever, fatigue and dry cough that are the main clinical symptoms a few patients will also show nasal congestion, runny nose, sore throat and diarrhea and other symptoms. Severe patients often have dyspnea and/or hypoxemia 1 week after onset of the disease, and the rapid progression for these patients include acute respiratory distress syndrome, septic shock, refractory metabolic acidosis and coagulation dysfunction.
According to the "Guidance of Diagnosis and Treatment for Patients with Coronavirus Disease 2019 (COVID-19) (Procedural Version 5 Amendment)" recently issued by National Health Commission of the People's Republic of China, the general treatment will include close monitoring vital signs and oxygen saturation at finger, additionally, monitoring routine blood test, routine urine test, coagulation function, arterial blood gas analysis based on individual condition, and providing effective oxygen inhalation treatment (including nasal catheter, mask oxygen supply and transnasal high flow oxygen therapy) in time.
T89 have the effects of activating blood circulation and removing blood stasis, regulating Qi and relieving pain. Four clinical trials conducted in China and abroad have shown that T89 can effectively alleviate the clinical symptoms of acute high altitude reaction, improve blood oxygen saturation, significantly increase the exercise time in treadmill and metabolic equivalents of task and enhance exercise tolerance under hypoxic environment. Modern pharmacological and gene network-based studies have shown that T89 can improve the oxygen carrying capacity of red blood cells, increase oxygen saturation, effectively reduce the injury of major organs such as heart, brain, lung and kidney caused by hypoxia, and prevent the decrease of oxygen saturation by improving the energy metabolism disorder caused by hypoxia. At the same time, T89 can inhibit the reduction of hematocrit, albumin leakage, neutrophil CD18 and adhesion factor of endothelial cells (ICAM-1), by which T89 has a good therapeutic effect on microcirculation disorders caused by many diseases.
In conclusion, T89 can improve the ability of carrying oxygen of red blood cells, increase the oxygen saturation, effectively reduce the injury of heart, brain, lung and kidney and other major organs caused by hypoxia, and it can significantly improve the microcirculation disorder. At the same time, in the "Guidance for the Diagnosis and Treatment of Infectious Atypical Pneumonia (Severe Acute Respiratory Syndromes, SARS) P (2003 edition)" has also recommended T89 can be used as a traditional Chinese patent medicine to treat patients of advanced stage and severe SARS lung asthma syndrome by its effect of promoting blood circulation and removing blood stasis. In conclusion, T89 can improve the oxygen saturation and the clinical symptoms of patients with Coronavirus Disease 2019 (COVID-19), as a result, there may be some benefits for these patients to use T89 in current clinical treatment.
This exploratory treatment clinical study is to investigate the effect of T89 on improving oxygen saturation and clinical symptoms in patients with Coronavirus Disease 2019 (COVID-19), with the study design characterized by open-label, randomized and blank-control. In this study, an estimated total of 120-240 male and female patients aged 18-85 years old who have been diagnosed with coronavirus pneumonia (COVID-19), not including critical type in severity, will be enrolled and randomly assigned to one of two study groups, the T89 treatment group and the blank control group, to receive T89 or nothing for up to 14 days on the base of a standard treatment recommended by the"Guidance of Diagnosis and Treatment for Patients with Coronavirus Disease 2019 (COVID-19) (Procedural Version 5 Amendment) .
As planned, this study will be started before March 2020 in hospitals located in Wuhan of Hubei province in China and completed at the end of next June 2020.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An open-label, randomized, blank-controlled treatment clinical study
| Arm | Type | Receives |
|---|---|---|
| The T89 treatment group | Experimental | Drug: T89Besides a standard background treatment (antiviral drug + antibacterial + oxygen therapy + Traditional Chinese Medicine decoction), all subjects in the T89 treatment group will receive 30 pills of T89 each time, orally, BID(every morning and evening), for 10 days (Depending on clinical need and practicability, the use can be extended for up to 14 days). |
| The blank control group | No intervention | –All subjects in the blank control group will only receive a standard background treatment (antiviral drug + antibacterial + oxygen therapy + Traditional Chinese Medicine decoction), for 10 days. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult male or female patients aged 18-85 years old;
- The newly diagnosed COVID-19 patients who meet the diagnostic criteria set forth in the "Guidance of Diagnosis and Treatment for Patients with Coronavirus Disease 2019 (COVID-19) (Procedural Version 5 Amendment)", issued by the National Health Commission of the People's Republic of China on 8 February 2020;
- Patients whose blood oxygen saturation is not less than 90%.
- Patients who agree to participate in the study and voluntarily comply with the relevant requirements of the study.
Key exclusion criteria (5 listed)
- Patients with other diseases that may affect, in the opinion of study researchers, the implementation of the study or the observation of the efficacy data;
- Patients with severe Coronavirus Disease 2019 (COVID-19), that is based on "Guidance of Diagnosis and Treatment for Patients with Coronavirus Disease 2019 (COVID-19) (Procedural Version 5 Amendment)" with respect to the criteria for clinical severity classification;
- Female patients with known pregnancy and in lactation at screening;
- Patients with previous allergies to T89 or Radix Salvia Miltiorrhizae, Radix Notoginseng and Borneol;
- Any other condition that, in the opinion of the investigator, may affect the conduct of the study, reduce compliance or increase the risk of patients.
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 |
|---|---|---|
| T89Also: DantonicThe subjects in the T89 treatment group will receive 30 pills of T89 orally, bid., for 10 days, except a standard background treatment (antiviral drug + antibacterial + oxygen therapy+ Traditional Chinese Medicine decoction). The subjects in the blank control group will only receive a standard background treatment. | Drug | The T89 treatment group |
Primary outcome
The time to oxygen saturation recovery to normal level (≥97%)
Time frame: Day -1 to 10
From screening to the end of treatment, for all patients randomized, oxygen saturation will be assessed for 3 times daily, the time to oxygen saturation recovery to normal level (≥97%) will be calculated finally based on that record and compared between two groups.
The proportion of patients with normal level of oxygen saturation(≥97%)
Time frame: Day -1 to 10
The proportion of patients with normal level of oxygen saturation(≥97%) after treatment will be calculated finally based on that record and compared between two groups.
16 secondary outcomes
The degree of remission of symptoms of patients, including: fatigue, nausea, vomiting, chest tightness, shortness of breath, etc.
Time frame: Day -1 to 10
The time to the myocardial enzyme spectrum recovery to normal after treatment
Time frame: Day -1, 3, 7 and 10
The proportion of the patients with normal myocardial enzyme spectrum after treatment
Time frame: Day -1, 3, 7 and 10
The time to the electrocardiogram recovery to normal level after treatment
Time frame: Day -1, 3, 7 and 10
The proportion of the patients with normal electrocardiogram after treatment
Time frame: Day -1, 3, 7 and 10
The time to the hemodynamics recovery to normal after treatment
Time frame: Day -1 and 10
The proportion of the patients with normal hemodynamics after treatment
Time frame: Day -1 and 10
The time to exacerbation or remission of the disease after treatment;
Time frame: Day -1 to 10
The proportion of the patients with exacerbation or remission of disease after treatment
Time frame: Day -1 to 10
The proportion of patients who need other treatment (e.g. heparin, anticoagulants) due to microcirculation disorders
Time frame: Day -1 to 10
The all-cause mortality rate
Time frame: Day -1 to 10
The proportion of patients with acidosis
Time frame: Day -1 and 10
The total duration of the patients in-hospital
Time frame: Day -1 to 10
The total duration of oxygen inhalation during treatment
Time frame: Day -1 to 10
The oxygen flow rate during treatment
Time frame: Day -1 to 10
The oxygen concentration during treatment
Time frame: Day -1 to 10
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 16 Jun 2020.
- Individual participant dataSharing planned: No. No plan to share
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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.
Shuiping Zhou, PhD study chair
Tasly Pharmaceutical Group Co., Ltd
Questions about this trial
What is this clinical trial studying?
A study testing T89 in people with Coronavirus Disease 2019 and Novel Coronavirus Pneumonia, run by Tasly Pharmaceuticals, Inc..
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 5 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 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The time to oxygen saturation recovery to normal level (≥97%) (time frame: Day -1 to 10). The study lists 2 primary outcomes in all. 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 16 Jun 2020.