This is a phase 2a, multicenter, randomized, double-blinded, placebo controlled, dose escalation study in adult subjects with COVID-19 pneumonia. The primary objective of this study is to evaluate the overall safety of F-652 in COVID subjects in order to identify safe dose(s) for future studies with adequate patient numbers to demonstrate clinical efficacy.
The study is planned to include 2 cohorts, with enrolled patients being randomized 2:1 in a blinded manner on Day 1, following screening, to F-652 or placebo as follows: * Cohort 1: subjects will receive up to two intravenous (IV) infusions of F-652 at dose 1 or placebo. Upon completion of Cohort 1, the data monitoring committee (DMC) will convene and review all available safety data to determine if the study can proceed to the next dose level. * Cohort 2: subjects will receive up to two IV infusions of F-652 at dose 2 or placebo. Approximately 60 eligible subjects will be enrolled in the study with 30 subjects per dose cohort. Each cohort will have about 20 subjects treated with F-652 and 10 subjects treated with matching placebo. All randomized subjects will receive standard-of-care treatments for COVID-19 per individual institution standards. Treatment will begin on Day 1 following randomization. Subjects will receive up to two IV infusions of F-652 or matching placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
The proportion of subjects with any treatment-emergent adverse events (TEAEs) during the study
Time frame: Day 1 to Day 60/End of Study (EOS)
Proportion (%) of subjects with any serious adverse events (SAEs) and drug-related adverse events (AEs) during the study
Time frame: Day 1 to Day 60/EOS
Proportion (%) of subjects with clinically significant abnormality in clinical laboratory tests and ECG during the study
Time frame: Day 1 to Day 28
Change in parameters for coagulopathy including D-dimer, fibrinogen, coagulation tests and platelet count during the study
Time frame: Day 1 to Day 28
Change in parameters of cardiac function including N-terminal-pro hormone brain natriuretic peptide (NT-proBNP) or brain natriuretic peptide (BNP) and high-sensitivity cardiac troponin (or troponin) during the study
Time frame: Day 1 to Day 28
Serum concentration of F-652 at specified timepoints
Time frame: At predefined timepoints from Day 1 to Day 14/End of Treatment (EOT)
Number of days with oxygen use during the treatment period
Time frame: Day 1 to Day 14/EOT
Change in the World Health Organization (WHO) 10-point ordinal scale during the study period
The World Health Organization 10-point ordinal scale is developed by a special committee at WHO to measure illness severity over time. The minimum value is 0, the maximum value is 10. Severity increases as the score increases. A 2-point reduction on the score is considered as clinical improvement.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 1 to Day 14/EOT and Day 28
Number of days hospitalized during the treatment period
Time frame: Day 1 to Day 14/EOT
Proportion (%) of subjects alive and free of respiratory failure during the study period
Time frame: Day 1 to Day 14/EOT, Day 28, and Day 60/EOS
All-cause mortality rate during the study period
Time frame: Day 1 to Day 14/EOT, Day 28, and Day 60/EOS