Coronavirus DiseasePhase 1NCT04464460
A Study to Evaluate the Safety, Pharmacokinetics (PK), and Efficacy of TAK-671 for the Treatment of Coronavirus Disease (COVID) 2019 in Adults
A Phase 1 study testing TAK-671 in people with Coronavirus Disease, run by Takeda.
Trial summary
The purpose of this study is to assess safety, tolerability, preliminary efficacy, and PK of TAK-671 in participants with COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronavirus Disease
- What is being tested?
- TAK-671
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2020to 30 Oct 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled Multicenter Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of 2 Different Intravenous Doses of TAK-671 for the Treatment of Coronavirus Disease 2019 in Adults
The purpose of this study is to assess safety, tolerability, preliminary efficacy, and PK of TAK-671 in participants with COVID-19.
Read the 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 respiratory syndrome coronavirus 2 (SARS-CoV-2) positive test.
The study will enroll approximately 40 participants. Each cohort will have 20 participants. Participants will be randomly assigned (by chance, like flipping a coin) in a 3:1 ratio to receive TAK-671 or placebo in each cohort, which will remain undisclosed to the participant during the study (unless there is an urgent medical need):
- Cohort 1: TAK-671 Low Dose
- Cohort 2: TAK-671 High Dose
Enrollment in Cohort 2 will only begin once all 20 participants in Cohort 1 have reached Day 7 post dose and have received positive review from the internal review committee (IRC) and approval to continue enrollment. All participants will receive the standard of care along with the study treatment.
This multi-center trial will be conducted in the United States. The overall time to participate in this study is approximately 3 months. All participants will be followed up 28 days after the infusion.
- Conditions
- Coronavirus Disease
- Being tested
- TAK-671, TAK-671 Placebo
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-671Drug
Also called SB26
TAK-671 intravenous infusion.
TAK-671 PlaceboDrug
Also called SB26/TAK-671 matching-placebo
TAK-671 placebo-matching intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: TAK-671; Drug: TAK-671 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Measured: Baseline up to Day 28
Number of Participants With Markedly Abnormal Laboratory Values
Measured: Baseline up to Day 28
Number of Participants With Markedly Abnormal Values of Vital Signs
Measured: Baseline up to Day 28
Number of Participants With Markedly Abnormal 12-lead Electrocardiograms
Measured: Baseline up to Day 28
Number of Participants With Adverse Events (AEs) Related to Physical Examination Findings
Measured: Baseline up to Day 28
Ceoi: Serum Concentration at the end of Infusion for TAK-671
Measured: Day 14: at the end of infusion (at 336 hours post infusion)
T1/2z: Terminal Disposition Serum Half-life for TAK-671
Measured: 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
Measured: 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
Measured: 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
Sustained clinical improvement is defined as a 2-point improvement on the 8-point ordinal scale for clinical improvement, that is at least 2 points increase from the lowest score recorded since randomization and no worsening of the score afterwards by Day 28. An 8-point ordinal scale for clinical improvement in COVID-19 symptoms ranges from a score of 1 to a score of 8, where 1 (death), 2 (hospitalized, on invasive mechanical ventilation or ECMO), 3 (hospitalized, on non-invasive ventilation or high-flow oxygen devices), 4 (hospitalized, requiring supplemental oxygen), 5 (hospitalized, not requiring supplemental oxygen, requiring ongoing medical care [COVID-19 related or otherwise]), 6 (hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care), 7 (not hospitalized, limitation on activities and/or requiring home oxygen), and 8 (not hospitalized, no limitations on activities).
Measured: Day 28
Percentage of Participants With Sustained Clinical Recovery
Sustained clinical recovery is defined as achieving score 6, 7, or 8 based on the ordinal scale and maintained the clinical recovery until Day 28. An 8-point ordinal scale for clinical improvement in COVID-19 symptoms ranges from a score of 1 to a score of 8, where 1 (death), 2 (hospitalized, on invasive mechanical ventilation or ECMO), 3 (hospitalized, on non-invasive ventilation or high-flow oxygen devices), 4 (hospitalized, requiring supplemental oxygen), 5 (hospitalized, not requiring supplemental oxygen, requiring ongoing medical care [COVID-19 related or otherwise]), 6 (hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care), 7 (not hospitalized, limitation on activities and/or requiring home oxygen), and 8 (not hospitalized, no limitations on activities).
Measured: Up to 28 days
Percentage of Participants With Sustained Remission of Respiratory Symptoms
Sustained remission of respiratory symptoms is defined as independence from supplemental oxygen therapy in order to maintain oxygen saturation (SpO2) greater than 94 percent (%) and is maintained up to Day 28.
Measured: Up to 28 days
Mortality Rate
Measured: Up to 28 days
Time to Sustained Clinical Improvement or Discharge From Hospital
Sustained clinical improvement is defined as a 2-point improvement on the 8-point ordinal scale for clinical improvement, that is at least 2 points increase from the lowest score recorded since randomization and no worsening of the score afterwards by Day 28. An 8-point ordinal scale for clinical improvement in COVID-19 symptoms ranges from a score of 1 to a score of 8, where 1 (death), 2 (hospitalized, on invasive mechanical ventilation or ECMO), 3 (hospitalized, on non-invasive ventilation or high-flow oxygen devices), 4 (hospitalized, requiring supplemental oxygen), 5 (hospitalized, not requiring supplemental oxygen, requiring ongoing medical care [COVID-19 related or otherwise]), 6 (hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care), 7 (not hospitalized, limitation on activities and/or requiring home oxygen), and 8 (not hospitalized, no limitations on activities).
Measured: Up to 28 days
Time to Sustained Clinical Recovery
Sustained clinical recovery is defined as achieving score 6, 7, or 8 based on the ordinal scale and maintained the clinical recovery until Day 28. An 8-point ordinal scale for clinical improvement in COVID-19 symptoms ranges from a score of 1 to a score of 8, where 1 (death), 2 (hospitalized, on invasive mechanical ventilation or ECMO), 3 (hospitalized, on non-invasive ventilation or high-flow oxygen devices), 4 (hospitalized, requiring supplemental oxygen), 5 (hospitalized, not requiring supplemental oxygen, requiring ongoing medical care [COVID-19 related or otherwise]), 6 (hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care), 7 (not hospitalized, limitation on activities and/or requiring home oxygen), and 8 (not hospitalized, no limitations on activities).
Measured: Up to 28 days
Percentage of Participants With Any Form of New Ventilation Use
Measured: Up to 28 days
Number of Days of New Ventilation Use
Measured: Up to 28 days
Number of Ventilation-free Days
Measured: Up to 28 days
Number of Days Free of Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)
Measured: Up to 28 days
Time to Sustained Remission of Respiratory Symptoms
Remission of respiratory symptoms is defined as independence from supplemental oxygen therapy in order to maintain SpO2 greater than 94%.
Measured: Up to 28 days
Percentage of Participants Admitted to Intensive Care Unit (ICU)
Measured: Up to 28 days
Number of Days of ICU Stay
Measured: Up to 28 days
Change From Baseline in Sequential Organ Failure Assessment (SOFA) Score at Days 7, 14, and 28
The SOFA score is a scale for describing multiple organ failure in the critical care setting. It is calculated using the functional status of several organ systems: respiratory, coagulation, liver, cardiovascular, central nervous system, and renal. Each of these organ systems is rated on a scale of 1 to 4, based on objective, testable criteria, chiefly laboratory values. The ratings of each of these systems (worse observed value during that 24-hour period) are then summed to create the total score. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). The minimum score is 0, the maximum score is 24, with higher scores indicating higher likelihood of worse outcome.
Measured: Baseline, Days 7, 14, and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start25 Sep 2020 (estimated)
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Why it stopped: Business Decision (no enrollment)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464460
- Sponsor's protocol ID
- TAK-671-1501
- Other IDs
- U1111-1252-9426
- Status last verified
- Oct 2020
- First submitted
- 8 Jul 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled Multicenter Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of 2 Different Intravenous Doses of TAK-671 for the Treatment of Coronavirus Disease 2019 in Adults
- ClinicalTrials.gov ID
- NCT04464460
- Acronym / sponsor ID
- TAK-671-1501
- Conditions
- Coronavirus Disease
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business Decision (no enrollment)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2020 (estimated)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 respiratory syndrome coronavirus 2 (SARS-CoV-2) positive test.
The study will enroll approximately 40 participants. Each cohort will have 20 participants. Participants will be randomly assigned (by chance, like flipping a coin) in a 3:1 ratio to receive TAK-671 or placebo in each cohort, which will remain undisclosed to the participant during the study (unless there is an urgent medical need):
- Cohort 1: TAK-671 Low Dose
- Cohort 2: TAK-671 High Dose
Enrollment in Cohort 2 will only begin once all 20 participants in Cohort 1 have reached Day 7 post dose and have received positive review from the internal review committee (IRC) and approval to continue enrollment. All participants will receive the standard of care along with the study treatment.
This multi-center trial will be conducted in the United States. The overall time to participate in this study is approximately 3 months. All participants will be followed up 28 days after the infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: TAK-671 Low Dose | Experimental | Drug: TAK-671, Drug: TAK-671 PlaceboTAK-671 low dose or TAK-671 placebo-matching, infusion over a 90-minute period, intravenously, once on Day 1. |
| Cohort 2: TAK-671 High Dose | Experimental | Drug: TAK-671, Drug: TAK-671 PlaceboTAK-671 high dose or TAK-671 placebo-matching, infusion over a 90-minute period, intravenously, once on Day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-671Also: SB26TAK-671 intravenous infusion. | Drug | Cohort 1: TAK-671 Low Dose, Cohort 2: TAK-671 High Dose |
| TAK-671 PlaceboAlso: SB26/TAK-671 matching-placeboTAK-671 placebo-matching intravenous infusion. | Drug | Cohort 1: TAK-671 Low Dose, Cohort 2: TAK-671 High Dose |
Primary outcome
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 28
Number of Participants With Markedly Abnormal Laboratory Values
Time frame: Baseline up to Day 28
Number of Participants With Markedly Abnormal Values of Vital Signs
Time frame: Baseline up to Day 28
Number of Participants With Markedly Abnormal 12-lead Electrocardiograms
Time frame: Baseline up to Day 28
Number of Participants With Adverse Events (AEs) Related to Physical Examination Findings
Time frame: Baseline up to Day 28
Ceoi: Serum Concentration at the end of Infusion for TAK-671
Time frame: Day 14: at the end of infusion (at 336 hours post infusion)
T1/2z: Terminal Disposition Serum Half-life for TAK-671
Time frame: 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
Time frame: 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
Time frame: Day 0 pre-infusion and at multiple time points (up to 336 hours) post-infusion
14 secondary outcomes
Percentage of Participants With Sustained Clinical Improvement or Live Discharge at Day 28
Time frame: Day 28
Percentage of Participants With Sustained Clinical Recovery
Time frame: Up to 28 days
Percentage of Participants With Sustained Remission of Respiratory Symptoms
Time frame: Up to 28 days
Mortality Rate
Time frame: Up to 28 days
Time to Sustained Clinical Improvement or Discharge From Hospital
Time frame: Up to 28 days
Time to Sustained Clinical Recovery
Time frame: Up to 28 days
Percentage of Participants With Any Form of New Ventilation Use
Time frame: Up to 28 days
Number of Days of New Ventilation Use
Time frame: Up to 28 days
Number of Ventilation-free Days
Time frame: Up to 28 days
Number of Days Free of Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)
Time frame: Up to 28 days
Time to Sustained Remission of Respiratory Symptoms
Time frame: Up to 28 days
Percentage of Participants Admitted to Intensive Care Unit (ICU)
Time frame: Up to 28 days
Number of Days of ICU Stay
Time frame: Up to 28 days
Change From Baseline in Sequential Organ Failure Assessment (SOFA) Score at Days 7, 14, and 28
Time frame: Baseline, Days 7, 14, and 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAK-671 in people with Coronavirus Disease, run by Takeda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) (time frame: Baseline up to Day 28). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.