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.
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 number of people up to 68,500 totally in China were diagnosed with a new type
of disease of Coronavirus Disease 2019 (COVID-19) and 1665 peoples were died due to this
disease in China. Based on the recent epidemiological investigation, the incubation period of
this new coronavirus is 1-14 days and 3-7 days for most people before they show any symptom,
such as fever, fatigue and dry cough that are the main clinical symptoms a few patients will
also show nasal congestion, runny nose, sore throat and diarrhea and other symptoms. Severe
patients often have dyspnea and/or hypoxemia 1 week after onset of the disease, and the rapid
progression for these patients include acute respiratory distress syndrome, septic shock,
refractory metabolic acidosis and coagulation dysfunction.
According to the "Guidance of Diagnosis and Treatment for Patients with Coronavirus Disease
2019 (COVID-19) (Procedural Version 5 Amendment)" recently issued by National Health
Commission of the People's Republic of China, the general treatment will include close
monitoring vital signs and oxygen saturation at finger, additionally, monitoring routine
blood test, routine urine test, coagulation function, arterial blood gas analysis based on
individual condition, and providing effective oxygen inhalation treatment (including nasal
catheter, mask oxygen supply and transnasal high flow oxygen therapy) in time.
T89 have the effects of activating blood circulation and removing blood stasis, regulating Qi
and relieving pain. Four clinical trials conducted in China and abroad have shown that T89
can effectively alleviate the clinical symptoms of acute high altitude reaction, improve
blood oxygen saturation, significantly increase the exercise time in treadmill and metabolic
equivalents of task and enhance exercise tolerance under hypoxic environment. Modern
pharmacological and gene network-based studies have shown that T89 can improve the oxygen
carrying capacity of red blood cells, increase oxygen saturation, effectively reduce the
injury of major organs such as heart, brain, lung and kidney caused by hypoxia, and prevent
the decrease of oxygen saturation by improving the energy metabolism disorder caused by
hypoxia. At the same time, T89 can inhibit the reduction of hematocrit, albumin leakage,
neutrophil CD18 and adhesion factor of endothelial cells (ICAM-1), by which T89 has a good
therapeutic effect on microcirculation disorders caused by many diseases.
In conclusion, T89 can improve the ability of carrying oxygen of red blood cells, increase
the oxygen saturation, effectively reduce the injury of heart, brain, lung and kidney and
other major organs caused by hypoxia, and it can significantly improve the microcirculation
disorder. At the same time, in the "Guidance for the Diagnosis and Treatment of Infectious
Atypical Pneumonia (Severe Acute Respiratory Syndromes, SARS) P (2003 edition)" has also
recommended T89 can be used as a traditional Chinese patent medicine to treat patients of
advanced stage and severe SARS lung asthma syndrome by its effect of promoting blood
circulation and removing blood stasis. In conclusion, T89 can improve the oxygen saturation
and the clinical symptoms of patients with Coronavirus Disease 2019 (COVID-19), as a result,
there may be some benefits for these patients to use T89 in current clinical treatment.
This exploratory treatment clinical study is to investigate the effect of T89 on improving
oxygen saturation and clinical symptoms in patients with Coronavirus Disease 2019 (COVID-19),
with the study design characterized by open-label, randomized and blank-control. In this
study, an estimated total of 120-240 male and female patients aged 18-85 years old who have
been diagnosed with coronavirus pneumonia (COVID-19), not including critical type in
severity, will be enrolled and randomly assigned to one of two study groups, the T89
treatment group and the blank control group, to receive T89 or nothing for up to 14 days on
the base of a standard treatment recommended by the"Guidance of Diagnosis and Treatment for
Patients with Coronavirus Disease 2019 (COVID-19) (Procedural Version 5 Amendment) .
As planned, this study will be started before March 2020 in hospitals located in Wuhan of
Hubei province in China and completed at the end of next June 2020.
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
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.
Shuiping Zhou, PhD, Study Chair
Tasly Pharmaceutical Group Co., Ltd