A Study of Baricitinib (LY3009104) in Participants With COVID-19
A Study of Baricitinib (LY3009104) in Participants With COVID-19
The reason for this study is to see if the study drug baricitinib is effective in
 hospitalized participants with COVID-19.
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.

 -  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.

 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 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.