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

NCT04285190 | Withdrawn

• 1 other identifier: T89-NCP-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronavirus Disease 2019; Novel Coronavirus Pneumonia

Keywords

COVID-19

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (16)

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

  Day -1 to 10

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

  Day -1, 3, 7 and 10

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

  Day -1, 3, 7 and 10

• The time to the electrocardiogram recovery to normal level after treatment

  Day -1, 3, 7 and 10

• The proportion of the patients with normal electrocardiogram after treatment

  Day -1, 3, 7 and 10

Study Arms (2)

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).

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.

Interventions

T89 DRUG

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.

Also known as: Dantonic

The T89 treatment group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tasly Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

COVID-19

Interventions

T89 herbal drug

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Shuiping Zhou, PhD

  Tasly Pharmaceutical Group Co., Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An open-label, randomized, blank-controlled treatment clinical study

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 26, 2020
• Study Start: February 26, 2020
• Primary Completion: April 15, 2020
• Study Completion: April 20, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share