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A Study of Baricitinib (LY3009104) in Participants With COVID-19 (COV-BARRIER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04421027
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The reason for this study is to see if the study drug baricitinib is effective in hospitalized participants with COVID-19.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Baricitinib Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Study of Baricitinib in Patients With COVID-19 Infection
Actual Study Start Date : June 12, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Baricitinib
4 milligrams (mg) of baricitinib given orally with background therapy.
Drug: Baricitinib
Given orally
Other Name: LY3009104

Placebo Comparator: Placebo
Placebo given orally with background therapy.
Drug: Placebo
Given orally




Primary Outcome Measures :
  1. Percentage of Participants who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (including extracorporeal membrane oxygenation [ECMO]) [ Time Frame: Day 1 to Day 28 ]
    Percentage of Participants who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (including ECMO)


Secondary Outcome Measures :
  1. Percentage of Participants with at Least 1-Point Improvement on NIAID-OS or Live Discharge from Hospital [ Time Frame: Day 10 ]
    The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: Death; Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities.

  2. Number of Ventilator-Free Days [ Time Frame: Day 1 to Day 28 ]
    Number of Ventilator-Free Days

  3. Time to Recovery [ Time Frame: Day 1 to Day 28 ]
    Recovery assessed by the NIAID-OS.

  4. Overall Improvement on the NIAID-OS [ Time Frame: Day 1 to Day 28 ]
    Overall Improvement on the NIAID-OS

  5. Duration of Hospitalization [ Time Frame: Day 1 to Day 28 ]
    Duration of Hospitalization

  6. Percentage of Participants with a Change in Oxygen Saturation from <94% to ≥94% from Baseline [ Time Frame: Day 10 ]
    Percentage of Participants with a Change in Oxygen Saturation from <94% to ≥94% from Baseline

  7. Mortality [ Time Frame: Day 1 to Day 28 ]
    Mortality

  8. Duration of Stay in the Intensive Care Unit (ICU) in Days [ Time Frame: Day 1 to Day 28 ]
    Duration of Stay in the ICU in Days

  9. Time to Clinical Deterioration (one-category increase on the NIAID-OS) [ Time Frame: Day 1 to Day 28 ]
    Time to Clinical Deterioration (one-category increase on the NIAID-OS)

  10. Time to Resolution of Fever, in Participants with Fever at Baseline [ Time Frame: Day 1 to Day 28 ]
    Time to Resolution of Fever, in Participants with Fever at Baseline

  11. Mean Change from Baseline on the National Early Warning Score (NEWS) [ Time Frame: Baseline, Day 1 to Day 28 ]
    The NEWS is used to detect and report changes in illness severity in participants with acute illness. The score is determined from six physiological parameters readily measured over time in hospitalized participants: Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness

  12. Time to Definitive Extubation [ Time Frame: Day 1 to Day 28 ]
    Time to Definitive Extubation

  13. Time to Independence from Non-Invasive Mechanical Ventilation [ Time Frame: Day 1 to Day 28 ]
    Time to Independence from Non-Invasive Mechanical Ventilation

  14. Time to Independence from Oxygen Therapy in Days [ Time Frame: Day 1 to Day 28 ]
    Time to Independence from Oxygen Therapy in Days

  15. Number of Days with Supplemental Oxygen Use [ Time Frame: Day 1 to Day 28 ]
    Number of Days with Supplemental Oxygen Use

  16. Number of Days of Resting Respiratory Rate <24 Breaths per Minute [ Time Frame: Day 1 to Day 28 ]
    Number of Days of Resting Respiratory Rate <24 Breaths per Minute



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalized with coronavirus (SARS-CoV-2) infection, confirmed by polymerase chain reaction (PCR) test or other commercial or public health assay in any specimen, as documented by either of the following:

    • PCR positive in sample collected <72 hours prior to randomization; OR
    • PCR positive in sample collected ≥72 hours prior to randomization (but no more than 14 days prior to randomization), documented inability to obtain a repeat sample (for example, due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection.
  • Have evidence of pneumonia (SpO2 <94 or PaO2/FiO2 [or SpO2/FiO2] ratio <300 mmHg or chest imaging findings consistent with pneumonia), OR have evidence of active COVID infection (with clinical symptoms including any of the following: fever, vomiting, diarrhea, dry cough, tachypnea defined as respiratory rate >24 breaths/minute).
  • Have indicators of risk of progression: at least 1 inflammatory markers >upper limit of normal (ULN) (C reactive protein [CRP], D dimer, lactate dehydrogenase [LDH], ferritin) with at least 1 instance of elevation >ULN within 2 days before study entry.

Exclusion Criteria:

  • Are receiving cytotoxic or biologic treatments (such as tumor necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication at study entry. Note: A washout period 4 weeks (or 5 half-lives, whichever is longer) is required prior to screening.
  • Have ever received convalescent plasma or intravenous immunoglobulin [IVIg]) for COVID-19.
  • Have received high dose corticosteroids at doses >20 mg per day (or prednisone equivalent) administered for ≥14 consecutive days in the month prior to study entry.
  • Strong inhibitors of OAT3 (such as probenecid) that cannot be discontinued at study entry.
  • Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required).
  • Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.
  • Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study. Note: Use of nonlive (inactivated) vaccinations is allowed for all participants.
  • Require invasive mechanical ventilation, including extracorporeal membrane oxygenation (ECMO) at study entry.
  • Current diagnosis of active malignancy that, in the opinion of the investigator, could constitute a risk when taking investigational product.
  • Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and pulmonary embolism [PE]) within 12 weeks prior to randomization or have a history of recurrent (>1) VTE (DVT/PE).
  • Anticipated discharge from the hospital, or transfer to another hospital (or another unit), which is not a study site within 72 hours after study entry.
  • Have neutropenia (absolute neutrophil count <1000 cells/microliters).
  • Have lymphopenia (absolute lymphocyte count <200 cells/microliters).
  • Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times ULN.
  • Estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD]) <30 milliliter/minute/1.73 meters squared.
  • Have a known hypersensitivity to baricitinib or any of its excipients.
  • Are currently enrolled in any other clinical study involving an investigation product or any other type of medical research judged not to be scientifically or medically compatible with this study. Note: The participant should not be enrolled (start) in another clinical trial for the treatment of COVID-19 or SARS CoV-2 through Day 28.
  • Are pregnant, or intend to become pregnant or breastfeed during the study.
  • Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®.
  • Are, in the opinion of the investigator, unlikely to survive for at least 48 hours after screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04421027


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
Show Show 62 study locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-265-4559 or 1-317-615-4559) Mon - Fri 9AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04421027    
Other Study ID Numbers: 17830
I4V-MC-KHAA ( Other Identifier: Eli Lilly and Company )
2020-001517-21 ( EudraCT Number )
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting
Access Criteria: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting
URL: http://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
coronavirus
coronavirus infection
safety