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

NCT04646031 | Unknown

• 1 other identifier: T89-ROUSA-01
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Twenty (20) patients with severe COVID-19 as participants

Interventions

T89 capsule DRUG

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.

Also known as: Dantonic

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tasly Pharmaceuticals, Inc.: lead
• Tasly Pharmaceutical Group Co., Ltd: collaborator

Study Sites (1)

MultiCare Health System

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

T89 herbal drug

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Patrick Meehan, PhD, MD

  MultiCare Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: November 27, 2020
• Last Updated: August 8, 2023

Record last verified: 2023-08

Locations

US (1)