Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Clinical Study to Investigate the Effect of T89 on Improving Oxygen Saturation and Clinical Symptoms in Patients With Coronavirus Disease 2019 (COVID-19)

Trial Profile

A Clinical Study to Investigate the Effect of T89 on Improving Oxygen Saturation and Clinical Symptoms in Patients With Coronavirus Disease 2019 (COVID-19)

Status: Withdrawn prior to enrolment
Phase of Trial: Phase II

Latest Information Update: 17 Jun 2020

At a glance

  • Drugs T 89 (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Sponsors Tasly Pharmaceuticals, Inc.
  • Most Recent Events

    • 12 Jun 2020 Status changed from not yet recruiting to withdrawn prior to enrolment.
    • 02 Mar 2020 New trial record

Trial Overview

Purpose

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.

Comments

According to clinical.gov., this trial has been withdrawn as the COVID-19 pandemic in China has ended completely. As a result, patient recruiting is impossible in China.

Primary Endpoints

The time to oxygen saturation recovery to normal level (≥97%)

description: 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.
time_frame: Day -1 to 10

The proportion of patients with normal level of oxygen saturation(≥97%)

description: 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.
time_frame: Day -1 to 10

Other Endpoints

The degree of remission of symptoms of patients, including: fatigue, nausea, vomiting, chest tightness, shortness of breath, etc.

description: 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.
time_frame: Day -1 to 10

The time to the myocardial enzyme spectrum recovery to normal after treatment

description: 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.
time_frame: Day -1, 3, 7 and 10

The proportion of the patients with normal myocardial enzyme spectrum after treatment

description: 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.
time_frame: Day -1, 3, 7 and 10

The time to the electrocardiogram recovery to normal level after treatment

description: 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.
time_frame: Day -1, 3, 7 and 10

The proportion of the patients with normal electrocardiogram after treatment

description: 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.
time_frame: Day -1, 3, 7 and 10

The time to the hemodynamics recovery to normal after treatment

description: 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.
time_frame: Day -1 and 10

The proportion of the patients with normal hemodynamics after treatment

description: 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.
time_frame: Day -1 and 10

The time to exacerbation or remission of the disease after treatment;

description: 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.
time_frame: Day -1 to 10

The proportion of the patients with exacerbation or remission of disease after treatment

description: 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.
time_frame: Day -1 to 10

The proportion of patients who need other treatment (e.g. heparin, anticoagulants) due to microcirculation disorders

description: From screening to the end of treatment, for all patients randomized, the need for additional treatment will be recorded and compared between two groups.
time_frame: Day -1 to 10

The all-cause mortality rate

description: For all patients, the mortality will be recorded in each group and the rate will be compared between two groups.
time_frame: Day -1 to 10

The proportion of patients with acidosis

description: 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.
time_frame: Day -1 and 10

The total duration of the patients in-hospital

description: For all patients, the duration of hospitalization will be recorded in each group and compared between two groups.
time_frame: Day -1 to 10

The total duration of oxygen inhalation during treatment

description: 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.
time_frame: Day -1 to 10

The oxygen flow rate during treatment

description: 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.
time_frame: Day -1 to 10

The oxygen concentration during treatment

description: 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.
time_frame: Day -1 to 10 [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 120

    Actual: 0

  • Sex male & female
  • Age Group 18-85 years; adult; elderly

Patient 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.

Patient 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.

Trial Details

Identifiers

Identifier Owner
NCT04285190 ClinicalTrials.gov: US National Institutes of Health
T89NCP01 -

Organisations

  • Sponsors Tasly Pharmaceuticals, Inc.
  • Affiliations Tasly Pharmaceuticals, Inc.

Trial Dates

  • Initiation Dates

    Planned : 26 Feb 2020

    Actual : 26 Feb 2020

  • Primary Completion Dates

    Planned : 15 Jun 2020

    Actual : 15 Apr 2020

  • End Dates

    Planned : 15 Sep 2020

    Actual : 20 Apr 2020

Other Details

  • Design open; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location China
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
T 89Primary Drug Oral Pill

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

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.

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Shuiping Zhou, PhD Tasly Pharmaceutical Group Co., Ltd
-
Yi He, PhD
86-022-86343860
heyi@tasly.com
show details
, Tasly Pharmaceuticals, Inc.
-

Centres

Centre Name Location Trial Centre Country
-
-
-
Tasly Pharmaceutical Group Co., Ltd
-
-
Tasly Pharmaceuticals, Inc.
-
-

Trial History

Event Date Event Type Comment
17 Jun 2020 Other trial event Last checked against Clinicaltrials.gov record. Updated 17 Jun 2020
12 Jun 2020 Status change - withdrawn prior to enrolment Status changed from not yet recruiting to withdrawn prior to enrolment. Updated 17 Jun 2020
02 Mar 2020 New trial record New trial record Updated 02 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
Back to top