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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 22, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE June 5, 2020
First Posted Date  ICMJE June 9, 2020
Last Update Posted Date July 22, 2020
Actual Study Start Date  ICMJE June 12, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2020)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2020)
  • 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.
  • Number of Ventilator-Free Days [ Time Frame: Day 1 to Day 28 ]
    Number of Ventilator-Free Days
  • Time to Recovery [ Time Frame: Day 1 to Day 28 ]
    Recovery assessed by the NIAID-OS.
  • Overall Improvement on the NIAID-OS [ Time Frame: Day 1 to Day 28 ]
    Overall Improvement on the NIAID-OS
  • Duration of Hospitalization [ Time Frame: Day 1 to Day 28 ]
    Duration of Hospitalization
  • 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
  • Mortality [ Time Frame: Day 1 to Day 28 ]
    Mortality
  • 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
  • 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)
  • 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
  • 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
  • Time to Definitive Extubation [ Time Frame: Day 1 to Day 28 ]
    Time to Definitive Extubation
  • Time to Independence from Non-Invasive Mechanical Ventilation [ Time Frame: Day 1 to Day 28 ]
    Time to Independence from Non-Invasive Mechanical Ventilation
  • Time to Independence from Oxygen Therapy in Days [ Time Frame: Day 1 to Day 28 ]
    Time to Independence from Oxygen Therapy in Days
  • Number of Days with Supplemental Oxygen Use [ Time Frame: Day 1 to Day 28 ]
    Number of Days with Supplemental Oxygen Use
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Baricitinib (LY3009104) in Participants With COVID-19
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Study of Baricitinib in Patients With COVID-19 Infection
Brief Summary The reason for this study is to see if the study drug baricitinib is effective in hospitalized participants with COVID-19.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: Baricitinib
    Given orally
    Other Name: LY3009104
  • Drug: Placebo
    Given orally
Study Arms  ICMJE
  • Experimental: Baricitinib
    4 milligrams (mg) of baricitinib given orally with background therapy.
    Intervention: Drug: Baricitinib
  • Placebo Comparator: Placebo
    Placebo given orally with background therapy.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2020)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Argentina,   Brazil,   Germany,   Italy,   Japan,   Mexico,   Russian Federation,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04421027
Other Study ID Numbers  ICMJE 17830
I4V-MC-KHAA ( Other Identifier: Eli Lilly and Company )
2020-001517-21 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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/
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP