Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
by Phyllis Tien (ucsf)
Photo of Phyllis Tien
Phyllis Tien

Description

Summary

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

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Study of Baricitinib in Patients With COVID-19 Infection

Keywords

COVID-19 coronavirus coronavirus infection safety Baricitinib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join 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 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 (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.

Locations

  • San Francisco VA Medical Center accepting new patients
    San Francisco California 94121 United States
  • Hoag Memorial Hospital Presbyterian accepting new patients
    Newport Beach California 92663 United States
  • Sharp Memorial Hospital accepting new patients
    San Diego California 92123 United States

Lead Scientist at UC Health

  • Phyllis Tien (ucsf)
    Dr. Tien is Professor of Medicine in the Division of Infectious Diseases at the University of California, San Francisco (UCSF) and a Staff Physician at the San Francisco Veterans Affairs Medical Center (SFVAMC).

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of Baricitinib (LY3009104) in Participants With COVID-19 (COV-BARRIER)
ID
NCT04421027
Phase
Phase 3
Study Type
Interventional
Last Updated