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

Completed · Phase 3 · Has a placebo group

Conditions studied: COVID-19

In brief

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

Key facts

Study ID

NCT04421027

Run by

Eli Lilly and Company

People needed

1525

Starts

2020-06-12

Expected to finish

2021-06-10

Last updated by the study team

2022-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Requires supplemental oxygen at the time of study entry and at randomization.
• 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.

You may not qualify if…

• 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 received neutralizing antibodies, such as bamlanivimab, casirivimab and imdevimab for COVID-19.
• 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/or 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 (started) 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.

Where it is running

• Valleywise Health — Phoenix, Arizona, United States
• St Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• San Francisco VA Medical Center — San Francisco, California, United States
• Torrance Memorial Medical Center — Torrance, California, United States
• Holy Cross Hospital Inc. — Fort Lauderdale, Florida, United States
• Westchester General Hospital — Miami, Florida, United States
• Grady Health System — Atlanta, Georgia, United States
• Atlanta VA Medical Center — Decatur, Georgia, United States
• Great Lakes Clinical Trials — Chicago, Illinois, United States
• Parkview Regional Medical Center — Fort Wayne, Indiana, United States
• Community Hospital South — Indianapolis, Indiana, United States
• Franciscan St. Francis Health — Indianapolis, Indiana, United States
• South Shore Hospital — Weymouth, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Renown Regional Med. Center — Reno, Nevada, United States
• SUNY Downstate — Brooklyn, New York, United States
• East Carolina University — Greenville, North Carolina, United States
• OSU Med Intl Med Houston Ctr — Tulsa, Oklahoma, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Temple Univ School of Med — Philadelphia, Pennsylvania, United States
• Swedish Medical Center — Seattle, Washington, United States
• MultiCare Good Samaritan Hospital — Tacoma, Washington, United States
• Dignity Health Mercy Gilbert Medical Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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