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

Studies

Study First Submitted Date 2020-11-24
Study First Posted Date 2020-11-27
Last Update Posted Date 2023-08-08
Verification Month Year August 2023
Verification Date 2023-08-31
Last Update Posted Date 2023-08-08

Detailed Descriptions

Sequence: 20730905
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.

Facilities

Sequence: 200202408
Name MultiCare Health System
City Tacoma
State Washington
Zip 98405
Country United States

Conditions

Sequence: 52195332
Name Covid19
Downcase Name covid19

Id Information

Sequence: 40176775
Id Source org_study_id
Id Value T89-ROUSA-01

Countries

Sequence: 42590074
Name United States
Removed False

Interventions

Sequence: 52510115
Intervention Type Drug
Name T89 capsule
Description 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.

Keywords

Sequence: 79904106
Name Twenty (20) patients with severe COVID-19 as participants
Downcase Name twenty (20) patients with severe covid-19 as participants

Browse Conditions

Sequence: 193578647 Sequence: 193578648 Sequence: 193578649 Sequence: 193578650 Sequence: 193578651 Sequence: 193578652 Sequence: 193578653 Sequence: 193578654 Sequence: 193578655 Sequence: 193578656 Sequence: 193578657 Sequence: 193578658
Mesh Term COVID-19 Mesh Term Pneumonia, Viral Mesh Term Pneumonia Mesh Term Respiratory Tract Infections Mesh Term Infections Mesh Term Virus Diseases Mesh Term Coronavirus Infections Mesh Term Coronaviridae Infections Mesh Term Nidovirales Infections Mesh Term RNA Virus Infections Mesh Term Lung Diseases Mesh Term Respiratory Tract Diseases
Downcase Mesh Term covid-19 Downcase Mesh Term pneumonia, viral Downcase Mesh Term pneumonia Downcase Mesh Term respiratory tract infections Downcase Mesh Term infections Downcase Mesh Term virus diseases Downcase Mesh Term coronavirus infections Downcase Mesh Term coronaviridae infections Downcase Mesh Term nidovirales infections Downcase Mesh Term rna virus infections Downcase Mesh Term lung diseases Downcase Mesh Term respiratory tract diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48341625 Sequence: 48341626
Agency Class INDUSTRY Agency Class INDUSTRY
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Tasly Pharmaceuticals, Inc. Name Tasly Pharmaceutical Group Co., Ltd

Overall Officials

Sequence: 29298754
Role Principal Investigator
Name Patrick Meehan, PhD, MD
Affiliation MultiCare Health System

Eligibilities

Sequence: 30779491
Gender All
Minimum Age N/A
Maximum Age N/A
Criteria Inclusion Criteria: Was hospitalized due to COVID-19 confirmed by positive testing of standard reverse transcription-polymerase chain reaction (RT-PCR) assay; Clinical signs indicative of severe systemic illness with COVID-19, such as respiratory rate ≥30 per minute, heart rate ≥125 per minute, oxygen saturation by pulse oximetry (SpO2) ≤86% on room air or PaO2/FiO2 <300 (PaO2=Arterial oxygen pressure, FiO2=Inspired oxygen fraction ); With at least one of following underlying diseases such as hypertension, diabetes, and cardiovascular disease; Oxygen therapy is clinically indicated at the start of screening. Abnormal low platelet counts and/or other measurements indicative of systemic thrombosis, such as platelet counts <150,000/µL; 0.6 μg/mL< D-dimer ≤2.0 μg/mL (i.e., 1.2-4×upper limit of normal(ULN); ULN=0.5 μg/mL). Exclusion Criteria: Requiring immediate intensive care unit (ICU) administration and treatment. Need for high-flow nasal cannula oxygen delivery, noninvasive ventilation, invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment. Have known congenital hypercoagulopathy including but not limited to factor V Leiden (FVL) homozygous and heterozygous, protein C or protein S deficiency. And patients who have hypercysteinemia. Have congenital bleeding disorder including but not limited to von Willebrand disease, hemophilia A (factor VIII deficiency) hemophilia B (factor IX deficiency). With alanine aminotransferase (ALT) ≥5×ULN, or aspartate aminotransferase (AST) ≥5×ULN, or alkaline phosphatase (ALP) ≥5×ULN, or Total Bilirubin (TBILI) ≥2×ULN, or platelet counts <50,000/µL, or neutrophil counts <1,000/µL. Has severe preexisting pulmonary disease including but not limited to chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, pneumonectomy etc. Subjects with extrinsic restrictive lung disease due to obesity can be enrolled. With stage 4 severe kidney failure (i.e. estimated glomerular filtration rate (eGFR) <30) or requiring dialysis. With congestive heart failure with New York Heart Association (NYHA).
Adult True
Child True
Older Adult True

Calculated Values

Sequence: 253973951
Number Of Facilities 1
Registered In Calendar Year 2020
Were Results Reported False
Has Us Facility True
Has Single Facility True

Intervention Other Names

Sequence: 26686036
Intervention Id 52510115
Name Dantonic

Responsible Parties

Sequence: 28891903
Responsible Party Type Sponsor