Overview

Baricitinib, Placebo and Antiviral Therapy for the Treatment of Patients With Moderate and Severe COVID-19

Status:
Terminated
Trial end date:
2021-05-12
Target enrollment:
0
Participant gender:
All
Summary
This phase II trial studies the effect of baricitinib in combination with antiviral therapy for the treatment of patients with moderate or severe coronavirus disease-2019 (COVID-19). Treatment with antiviral medications such as hydroxychloroquine, lopinavir/ritonavir, and/or remdesivir may act against infection caused by the virus responsible for COVID-19. Baricitinib may reduce lung inflammation. Giving baricitinib in combination with antiviral therapy may reduce the risk of the disease from getting worse and may help prevent the need for being placed on a ventilator should the disease worsen compared to antiviral therapy alone.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Southern California
Collaborator:
National Cancer Institute (NCI)
Treatments:
Hydroxychloroquine
Lopinavir
Ritonavir
Criteria
Inclusion Criteria:

- Positive polymerase chain reaction (PCR) for severe acute respiratory syndrome
coronavirus 2 (SARS-CoV2) in a respiratory tract sample OR positive anti-SARS CoV2 IgM
antibody test that is approved by Food and Drug Administration (FDA) or allowed under
an emergency use authorization; either result obtained within 5 days prior to study
entry

- Cough and/or pneumonia on chest imaging

- Moderate disease with risk factor(s): Peripheral capillary oxygen saturation (SpO2) >=
92% on room air with one of the following risk factors for development of severe
disease: age >= 60 years, receiving medication for hypertension, diagnosed diabetes
mellitus, known cardiac disease, chronic lung disease, obesity (body mass index [BMI]
>= 35 kg/m^2), active malignancy, immunosuppression (receiving biologics or
glucocorticoids >= 20 mg/d prednisone equivalent for > 2 weeks)

- Severe disease: SpO2 =< 92% on room air

- Ability to understand and the willingness to sign a written informed consent. Adults
not competent to consent will be enrolled with the use of an appropriate legally
authorized representative (per California Code, Health and Safety Code - HSC)

- FDA regulations generally require that the informed consent of a participant be
documented by the use of a written consent form approved by the IRB and signed
and dated by the participant or the participant's legally authorized
representative at the time of consent (21 case form report [CFR] 50.27[a]). In
light of COVID-19 infection control measures, the following procedure would
satisfy documentation of this requirement if the participant signing the informed
consent is in COVID-19 isolation. If the technology is available, electronic
methods of obtaining informed consent will be taken. The electronic consent and
Health Insurance Portability and Accountability Act (HIPAA) forms will be
uploaded and available through REDCap

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry, for
the duration of study participation, and for 7 days following completion of therapy.
NOTE: Should a woman become pregnant or suspect she is pregnant while participating in
this study, she should inform her treating physician immediately. Women of
child-bearing potential should use highly effective methods of birth control. These
are those methods of contraception, alone or in combination, that result in a low
failure rate (i.e, less than 1% per year) when used consistently and correctly

Exclusion Criteria:

- Mechanical ventilation, high-flow nasal oxygen, biphasic positive airway pressure
(BiPAP)

- Venous thromboembolism within 12 weeks or previously diagnosed thrombophilic
conditions or conditions that increase the risk of thrombosis. Individuals with > 1
episode of venous thromboembolism or pulmonary embolism in the past will also be
excluded

- Prior receipt of other immunomodulatory drugs (e.g., any JAK inhibitors,
immunomodulatory biologics, or other immunomodulatory investigational products) within
14 days prior to enrollment

- Current treatment with probenecid

- Known infection with human immunodeficiency syndrome (HIV), or active infection with
hepatitis B or hepatitis C

- Participant with known active or latent tuberculosis infection

- Pregnancy and lactation

- Any serious acute infections or known active or latent tuberculosis

- All enrolled participants will be screened for latent tuberculosis infection by
testing QuantiFERON-TB Gold Plus, but a documented negative test will not be
required prior to entry. If a participant is found to have positive QuantiFERON
that results after enrollment, baricitinib will be discontinued

- Solid organ transplant recipient

- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 x upper limit
of normal

- Absolute neutrophil count < 1000/mm^3

- Absolute lymphocyte count < 200/mm^3

- Hemoglobin < 8 g/dl

- Estimated glomerular filtration rate (GFR) < 30 mL/min/1.73 m^2

- Any medical condition in the opinion of the investigator that would place the
participant at undue high risk for participation in the trial

- Hypersensitivity to the active substance or to any of the excipients