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

NCT04464460 | Withdrawn Phase 1 FDA Drug

• 2 other identifiers: TAK-671-1501U1111-1252-9426
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Coronavirus Disease

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (9)

• Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

  Baseline up to Day 28

• Number of Participants With Markedly Abnormal Laboratory Values

  Baseline up to Day 28

• Number of Participants With Markedly Abnormal Values of Vital Signs

  Baseline up to Day 28

• Number of Participants With Markedly Abnormal 12-lead Electrocardiograms

  Baseline up to Day 28

• Number of Participants With Adverse Events (AEs) Related to Physical Examination Findings

  Baseline up to Day 28

• Ceoi: Serum Concentration at the end of Infusion for TAK-671

  Day 14: at the end of infusion (at 336 hours post infusion)

• T1/2z: Terminal Disposition Serum Half-life for TAK-671

  Day 0 pre-infusion and at multiple time points (up to 336 hours) post-infusion

• AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-671

  Day 0 pre-infusion and at multiple time points (up to 336 hours) post-infusion

• AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-671

  Day 0 pre-infusion and at multiple time points (up to 336 hours) post-infusion

Secondary Outcomes (14)

• Percentage of Participants With Sustained Clinical Improvement or Live Discharge at Day 28

  Day 28

• Percentage of Participants With Sustained Clinical Recovery

  Up to 28 days

• Percentage of Participants With Sustained Remission of Respiratory Symptoms

  Up to 28 days

• Mortality Rate

  Up to 28 days

• Time to Sustained Clinical Improvement or Discharge From Hospital

  Up to 28 days

Study Arms (2)

Cohort 1: TAK-671 Low Dose

EXPERIMENTAL

TAK-671 low dose or TAK-671 placebo-matching, infusion over a 90-minute period, intravenously, once on Day 1.

Drug: TAK-671; Drug: TAK-671 Placebo

Cohort 2: TAK-671 High Dose

EXPERIMENTAL

TAK-671 high dose or TAK-671 placebo-matching, infusion over a 90-minute period, intravenously, once on Day 1.

Drug: TAK-671; Drug: TAK-671 Placebo

Interventions

TAK-671 DRUG

TAK-671 intravenous infusion.

Also known as: SB26

Cohort 1: TAK-671 Low Dose; Cohort 2: TAK-671 High Dose

TAK-671 Placebo DRUG

TAK-671 placebo-matching intravenous infusion.

Also known as: SB26/TAK-671 matching-placebo

Cohort 1: TAK-671 Low Dose; Cohort 2: TAK-671 High Dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 9, 2020
• Study Start: September 25, 2020
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share