Status and phase
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About
This is a Phase II, multi-center, double-blind, randomized, interventional study in approximately 120 subjects to evaluate clinical benefit of CX-4945 in adult outpatients with SARS-CoV-2 and influenza viral infection-associated pneumonia. The subjects will be recruited into two domains, including SARS-CoV-2 and influenza virus domains. The study will compare the efficacy of Standard of Care (SOC) combined with CX-4945 against SOC paired with a placebo, utilizing a 1:1 allocation ratio in each domain.
Full description
Domain I: SARS-CoV-2 domain
Domain II: Influenza virus domain
Screening visit will collect health information and perform protocol specified tests to determine patients' eligibility. After screening visit, eligible subjects who fulfill all selection criteria for enrollment will be randomized into each of the arms. The CX-4945 will be administered at 400 mg BID for 5 days. Subjects will be followed up until Day 29.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Not currently hospitalized
Males or females aged ≥ 18 years at the time of signing the informed consent form (ICF)
Patients diagnosed with viral pneumonia, as determined by the investigator, who exhibit any of the subsequent criteria: presence of respiratory symptoms or fever (ear temperature ≥ 38 °C, base of the tongue temperature ≥ 37.5 °C, or axillary temperature ≥ 37 °C)
With a pneumonia severity index (PSI) of risk class II or III
Oxygen saturation measured by pulse oximetry (SpO2) ≥ 94% on room air at sea level
Positive test for SARS-CoV-2 or influenza virus infection, confirmed by rapid diagnostic test (excluding cases where both SARS-CoV-2 and influenza virus are positive)
Confirmed lower respiratory tract infection by X-ray
At screening, subjects capable of childbearing must provide a negative serum or urine pregnancy test. These subjects must also commit to adhering to the study-specified contraceptive methods throughout the study duration
Notes: Acceptable contraceptive methods include:
The participant (or legal representative) agrees and is able to adhere to study protocol-stated requirements, instructions, and restrictions in the investigator's judgement. Furthermore, the participant is capable of understanding and has signed the IRB-approved Informed Consent Form (ICF)
With at least two of the risk factors listed below: Age ≥ 50 years-old; cancer and a life expectancy of ≥ 6 months; HIV infection; immunocompromised patient; congestive heart failure (CHF), or coronary artery disease (CAD), or cardiomyopathies; chronic kidney disease (CKD); chronic liver disease; chronic lung disease; diabetes mellitus (DM); body mass index (BMI) > 25 kg/m2; asthma; cerebrovascular disease; cystic fibrosis; dementia; or current and former smoker
Exclusion Criteria
Subject received investigational treatment within 30 days prior to the study, or concurrent use of another investigational drug
Subject has a history of severe renal disease (required phosphate binders or dialysis)
Subject has chronic diarrhea, characterized by three or more loose stools daily for a minimum of four weeks
High likelihood of mortality within the next 48 hours, as assessed by the investigator
Subject showing signs of respiratory failure and mechanical ventilation is required
Subject with liver cirrhosis
Subject with hepatitis B and/or hepatitis C disease, unless the subject has an aspartate aminotransferase (AST) level ranging from 8 to 31 U/L and an alanine aminotransferase (ALT) level from 0 to 41 U/L
Known active tuberculosis
Current documented bacterial infection
Subject has a documented anaphylactic reaction, regardless of cause
Subject who has taken an antiviral agent against respiratory viral infection for a continuous duration of more than 24 hours before screening
Subject is with active gastrointestinal diseases including gastritis, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis
Subjects received warfarin within 14 days prior to screening or intend to during the screening or treatment phase
History of allergic reactions to any of the ingredients or components used in the manufacture of CX-4945
Women who are pregnant or breastfeeding, or planning pregnancy during the study
Note: Men and women of reproductive potential must commit to effective contraception methods or abstinence during the study. Any resulting pregnancies or suspected pregnancies must be reported to the treating physician immediately.
ALT or AST levels > 5 times upper limit of normal (ULN)
eGFR <30 mL/min/1.73m2 (calculated by the MDRD formula)
Absolute neutrophil count (ANC) <1000/μL
Have received treatment with a SARS-CoV-2 specific monoclonal antibody
Have received convalescent COVID-19 plasma treatment
Concurrent use of baricitinib
Any physical findings or illness history that may compromise study results or increase patient risk, as determined by the investigator
Primary purpose
Allocation
Interventional model
Masking
136 participants in 4 patient groups, including a placebo group
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Central trial contact
Becky Lin; Hylee Lee
Data sourced from clinicaltrials.gov
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