Status:
WITHDRAWN
The Effect of T89 on Improving Oxygen Saturation and Clinical Symptoms in Patients With COVID-19
Lead Sponsor:
Tasly Pharmaceuticals, Inc.
Conditions:
Coronavirus Disease 2019
Novel Coronavirus Pneumonia
Eligibility:
All Genders
18-85 years
Phase:
NA
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 pa...
Detailed Description
The breakout of a new type of coronavirus (SARS-CoV-2) begun in Wuhan of Hubei province in China in December 2019, and as a result of its rapid spreading nationwide, as of February 16, 2020, a large n...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04285190
Start Date
February 26 2020
End Date
April 20 2020
Last Update
June 16 2020
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