The purpose of this study is to evaluate the rate of decline in quantitative viral load measured in hospitalized patients with Influenza A infection
This is a randomized, placebo-controlled, double-blind phase IIa proof-of-concept study, designed to evaluate the effect of CR8020, CR6261, or placebo in hospitalized patients with influenza A infection that are receiving standard of care. Up to 262 participants will be randomized to receive 30 mg/kg of CR8020, 30 mg/kg of CR6261, or placebo. The study duration will be approximately 117 days for each participant. Prior to enrollment, participants will be screened to assess their eligibility. Eligible participants will be randomized to CR8020, CR6261, or placebo and study drug will be administered on Day 1. Participants will be followed up for 115 days in 9 visits on Days 2 to 8, Day 29, and Day 116 (end of study). After hospital discharge, the remaining follow-up visits will be performed as outpatient visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Rate of decline in quantitative viral load
Time frame: Baseline to Day 8
Clinical improvement
Daily influenza symptoms and signs: Four domains from the Influenza Intensity and Impact Questionnaire will be evaluated (scored 0-3: none, mild, moderate, severe): -Influenza symptoms (respiratory and systemic domains Impact on daily activities Impact on emotions Impact on others
Time frame: Baseline to Day 15
Rate of decline in quantitative viral load (subjects not intubated at baseline)
Time frame: Baseline to Day 8
Rate of decline in quantitative viral load (subjects intubated at baseline)
Time frame: Baseline to Day 8
Rate of decline in quantitative viral load
Time frame: Baseline to Day 8
Incidence of adverse events
Time frame: Baseline to Day 116
Incidence of serious adverse events
Time frame: Baseline to Day 116
Area under the curve of viral load
Time frame: Baseline to Day 8
Clinical course for ICU patients
Time frame: Baseline to Day 8
Length of hospital stay
Time frame: The duration of hospital stay, an expected average of 7 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Fresno, California, United States
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Stanford, California, United States
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Washington D.C., District of Columbia, United States
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Tampa, Florida, United States
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Chicago, Illinois, United States
Unnamed facility
Maywood, Illinois, United States
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Baltimore, Maryland, United States
Unnamed facility
Detroit, Michigan, United States
Unnamed facility
Royal Oak, Michigan, United States
Unnamed facility
Troy, Michigan, United States
...and 58 more locations
Survival times
Survival times measured from randomization to time of death
Time frame: Baseline to Day 116