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The Effect of T89 on Improving Oxygen Saturation and Clinical Symptoms in Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04285190
Recruitment Status : Not yet recruiting
First Posted : February 26, 2020
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Tasly Pharmaceuticals, Inc.

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Coronavirus Disease 2019 Novel Coronavirus Pneumonia Drug: T89 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An open-label, randomized, blank-controlled treatment clinical study
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : February 26, 2020
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : September 15, 2020


Arm Intervention/treatment
Experimental: The T89 treatment group
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).
Drug: T89
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.
Other Name: Dantonic

No Intervention: The blank control group
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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. The degree of remission of symptoms of patients, including: fatigue, nausea, vomiting, chest tightness, shortness of breath, etc. [ Time Frame: Day -1 to 10 ]
    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.

  2. The time to the myocardial enzyme spectrum recovery to normal after treatment [ Time Frame: Day -1, 3, 7 and 10 ]
    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.

  3. The proportion of the patients with normal myocardial enzyme spectrum after treatment [ Time Frame: Day -1, 3, 7 and 10 ]
    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.

  4. The time to the electrocardiogram recovery to normal level after treatment [ Time Frame: Day -1, 3, 7 and 10 ]
    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.

  5. The proportion of the patients with normal electrocardiogram after treatment [ Time Frame: Day -1, 3, 7 and 10 ]
    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.

  6. The time to the hemodynamics recovery to normal after treatment [ Time Frame: Day -1 and 10 ]
    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.

  7. The proportion of the patients with normal hemodynamics after treatment [ Time Frame: Day -1 and 10 ]
    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.

  8. The time to exacerbation or remission of the disease after treatment; [ Time Frame: Day -1 to 10 ]
    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.

  9. The proportion of the patients with exacerbation or remission of disease after treatment [ Time Frame: Day -1 to 10 ]
    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.

  10. The proportion of patients who need other treatment (e.g. heparin, anticoagulants) due to microcirculation disorders [ Time Frame: Day -1 to 10 ]
    From screening to the end of treatment, for all patients randomized, the need for additional treatment will be recorded and compared between two groups.

  11. The all-cause mortality rate [ Time Frame: Day -1 to 10 ]
    For all patients, the mortality will be recorded in each group and the rate will be compared between two groups.

  12. The proportion of patients with acidosis [ Time Frame: Day -1 and 10 ]
    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.

  13. The total duration of the patients in-hospital [ Time Frame: Day -1 to 10 ]
    For all patients, the duration of hospitalization will be recorded in each group and compared between two groups.

  14. The total duration of oxygen inhalation during treatment [ Time Frame: Day -1 to 10 ]
    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.

  15. The oxygen flow rate during treatment [ Time Frame: Day -1 to 10 ]
    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.

  16. The oxygen concentration during treatment [ Time Frame: Day -1 to 10 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04285190


Contacts
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Contact: Yi He, PhD 86-022-86343860 heyi@tasly.com

Sponsors and Collaborators
Tasly Pharmaceuticals, Inc.
Investigators
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Study Chair: Shuiping Zhou, PhD Tasly Pharmaceutical Group Co., Ltd

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Responsible Party: Tasly Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04285190    
Other Study ID Numbers: T89-NCP-01
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tasly Pharmaceuticals, Inc.:
COVID-19
Additional relevant MeSH terms:
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Coronavirus Infections
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Antiviral Agents
Anti-Infective Agents