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

NO_LONGER_AVAILABLE

Conditions studied: Covid19

In brief

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.

Key facts

Study ID

NCT04646031

Run by

Tasly Pharmaceuticals, Inc.

Last updated by the study team

2023-08-08

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• MultiCare Health System — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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