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

• Status: Withdrawn
• Trial end date: 2020-04-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tasly Pharmaceuticals, Inc.
• Treatments: Antiviral Agents

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.