Coronavirus Disease 2019 Clinical Trial
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)
Verified date | March 2020 |
Source | Tasly Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 20, 2020 |
Est. primary completion date | April 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. Adult male or female patients aged 18-85 years old; 2. 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; 3. Patients whose blood oxygen saturation is not less than 90%. 4. Patients who agree to participate in the study and voluntarily comply with the relevant requirements of the study. Exclusion Criteria: 1. 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; 2. 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; 3. Female patients with known pregnancy and in lactation at screening; 4. Patients with previous allergies to T89 or Radix Salvia Miltiorrhizae, Radix Notoginseng and Borneol; 5. 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Tasly Pharmaceuticals, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Day -1 to 10 | |
Primary | 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. | Day -1 to 10 | |
Secondary | 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. | Day -1 to 10 | |
Secondary | 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. | Day -1, 3, 7 and 10 | |
Secondary | 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. | Day -1, 3, 7 and 10 | |
Secondary | 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. | Day -1, 3, 7 and 10 | |
Secondary | 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. | Day -1, 3, 7 and 10 | |
Secondary | 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. | Day -1 and 10 | |
Secondary | 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. | Day -1 and 10 | |
Secondary | 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. | Day -1 to 10 | |
Secondary | 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. | Day -1 to 10 | |
Secondary | 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. | Day -1 to 10 | |
Secondary | 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. | Day -1 to 10 | |
Secondary | 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. | Day -1 and 10 | |
Secondary | 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. | Day -1 to 10 | |
Secondary | 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. | Day -1 to 10 | |
Secondary | 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. | Day -1 to 10 | |
Secondary | 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. | Day -1 to 10 |
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