NCT04646031

Expanded Access to T89 for Treatment Use in Intermediate-size Patients Population With COVID-19

Expanded Access Use of T89 in An Intermediate-size Patients Population for the Treatment of Severe "Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)" Infection Disease Patients (COVID-19)

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Tasly Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

This expanded access use program will provide a botanical drug of T89 for treatment use in an intermediate-size population infected with SARS-CoV-2 who have severe COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening condition.

Detailed description

T89 capsule is a botanical drug product for oral use. The drug substance of T89 capsule is the water extract of two widely used herb medicines: Danshen (Radix Saliva Miltiorrhize Bge., RSM) and Sanqi (Radix Notoginseng, RN). A large number of researches have shown that T89 has the effects of activating blood circulation and removing blood stasis. Clinical trials conducted in China and US also show that T89 can significantly improve blood oxygen saturation at high altitudes and alleviate the symptoms of hypoxia. It has been also reported that T89 is effective in treating myocardial ischemic diseases. Basic studies show that T89 can improve red blood cell oxygen delivery capacity, reduce reactive oxygen species (ROS) related tissue damage, alleviate tissue and organ injuries caused by ischemia by improving microcirculation, improve energy metabolism and increase adenosine triphosphate (ATP) production in myocardial tissue, inhibit the reduction of hematocrit, albumin leakage, neutrophil CD18 and intercellular cell adhesion molecule-1 (ICAM-1), preventing deterioration of microcirculation caused by ischemia and hypoxia, and inhibit platelet aggregation and adhesion. The objective of this expanded access program is to provide T89 for treatment use in an intermediate-size population with severe COVID-19, with the dosing regimen of 300mg (four T89 capsules) each time, orally, three time daily for 14 days, followed by a follow-up visit by call on Day 21.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	T89 capsule	T89 capsule, an medicinal product for oral use under active INDs in the US is a botanical drug containing 75mg active substance of the water extract of Danshen and Sanqi.

Timeline

• First posted: 2020-11-27
• Last updated: 2023-08-08

Locations

1 site across 1 country: United States