A Study to Evaluate the Safety, Pharmacokinetics (PK), and Efficacy of TAK-671 for the Treatment of Coronavirus Disease (COVID) 2019 in Adults

• Status: Withdrawn
• Trial end date: 2020-10-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess safety, tolerability, preliminary efficacy, and PK of TAK-671 in participants with COVID-19.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda

Criteria

Inclusion Criteria:

1. 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.

2. 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.

3. Has peripheral capillary SpO2 less than or equal to 93% on room air.

4. 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.

5. Female participants are post-menopausal or surgically sterile.

Exclusion Criteria:

1. Has received TAK-671 or ulinastatin (UTI) in a previous clinical study or as a therapeutic agent.

2. 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.

3. Has evidence of multiorgan failure, based on a SOFA score greater than 12.

4. Is on invasive mechanical ventilation.

5. Requires vasopressor support. (However, use of fluid support is not exclusionary.)

6. Has known or suspected venous thromboembolism.

7. Any female participant who is of child-bearing potential or is breastfeeding.

8. Has active tuberculosis or a clinical suspicion of latent tuberculosis.

9. Has fulminant hepatic or renal failure.

10. 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).

11. 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.

12. Has a life expectancy of less than 6 months due to reasons other than COVID-19 in the opinion of the investigator.

13. Has a do-not-resuscitate or do-not-intubate (DNR/DNI) order.