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

Eli Lilly and Company0 sites1,400 target enrollmentJune 10, 2020

ConditionsCOVID-19 infection MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations Therapeutic area: Diseases [C] - Virus Diseases [C02]

DrugsOlumiant

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: COVID-19 infection
Sponsor: Eli Lilly and Company
Enrollment: 1400
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 10, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility 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.
•\- 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 850
•F.1\.3 Elderly (\>\=65 years) yes

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.