Back to resultsExpanded Access to T89 for Treatment Use in Intermediate-size Patients Population With COVID-19
Primary Purpose
Covid19
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
T89 capsule
Sponsored by
About this trial
This is an expanded access trial for Covid19 focused on measuring Twenty (20) patients with severe COVID-19 as participants
Eligibility 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).
Sites / Locations
- MultiCare Health System
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT04646031
First Posted
November 24, 2020
Last Updated
August 4, 2023
Sponsor
Tasly Pharmaceuticals, Inc.
Collaborators
Tasly Pharmaceutical Group Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04646031
Brief Title
Expanded Access to T89 for Treatment Use in Intermediate-size Patients Population With COVID-19
Official Title
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)
Study Type
Expanded Access
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tasly Pharmaceuticals, Inc.
Collaborators
Tasly Pharmaceutical Group Co., Ltd
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Twenty (20) patients with severe COVID-19 as participants
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
T89 capsule
Other Intervention Name(s)
Dantonic
Intervention 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.
10. Eligibility
Sex
All
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Meehan, PhD, MD
Organizational Affiliation
MultiCare Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
MultiCare Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Expanded Access to T89 for Treatment Use in Intermediate-size Patients Population With COVID-19
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