Status:
WITHDRAWN
A Study to Evaluate the Safety, Pharmacokinetics (PK), and Efficacy of TAK-671 for the Treatment of Coronavirus Disease (COVID) 2019 in Adults
Lead Sponsor:
Takeda
Conditions:
Coronavirus Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess safety, tolerability, preliminary efficacy, and PK of TAK-671 in participants with COVID-19.
Detailed Description
The drug being tested in this study is called TAK-671. The study will evaluate the safety, tolerability and PK of TAK-671 in participants admitted to the hospital with a confirmed severe acute respira...
Eligibility Criteria
Inclusion
- Has laboratory-confirmed SARS-CoV-2 infection as determined via polymerase chain reaction or an accepted molecular assay of any specimen, example, respiratory, blood, urine, stool, other body fluid.
- It has been less than 72 hours since time of the participant's hospital admission, or, if hospital acquired COVID-19 is confirmed, less than 72 hours after confirmation of positive SARS-CoV-2 test or the onset of respiratory symptoms, whichever is first.
- Has peripheral capillary SpO2 less than or equal to 93% on room air.
- Weighs greater than or equal to (\>=) 50 kilogram (kg) and has a body mass index (BMI) 18 to 35 kilogram per square meter (kg/m\^2), inclusive.
- Female participants are post-menopausal or surgically sterile.
Exclusion
- Has received TAK-671 or ulinastatin (UTI) in a previous clinical study or as a therapeutic agent.
- Has received a human blood product (other than a transfusion needed for trauma treatment) or has been treated with a monoclonal antibody or Fc-fusion biologic within 5 years of the screening visit.
- Has evidence of multiorgan failure, based on a SOFA score greater than 12.
- Is on invasive mechanical ventilation.
- Requires vasopressor support. (However, use of fluid support is not exclusionary.)
- Has known or suspected venous thromboembolism.
- Any female participant who is of child-bearing potential or is breastfeeding.
- Has active tuberculosis or a clinical suspicion of latent tuberculosis.
- Has fulminant hepatic or renal failure.
- Has congestive heart failure of New York Heart Association Grade III or IV, pulmonary embolism, or any other serious cardiac condition (example, pericardial effusion or restrictive cardiomyopathy).
- Participant's progression to death is imminent and inevitable within the next 24 hours, regardless of cause and irrespective of the provision of treatments, in the opinion of the investigator.
- Has a life expectancy of less than 6 months due to reasons other than COVID-19 in the opinion of the investigator.
- Has a do-not-resuscitate or do-not-intubate (DNR/DNI) order.
Key Trial Info
Start Date :
September 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04464460
Start Date
September 25 2020
End Date
October 30 2020
Last Update
October 8 2020
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