This study is a double-blind,randomized,placebo-controlled study to evaluate the efficacy and safety of FB2001 for Inhalation in patients with mild to moderate Coronavirus Disease 2019(COVID-19). A total of about 1336 subjects are planned to be enrolled. The subjects will be randomized in a 1:1 ratio to FB2001 group or placebo group while both receiving standard of care treatment.
Coronavirus Disease 2019 (COVID -19) is a respiratory illness that can spread from person to person. The infectious agent that causes COVID -19 is a novel coronavirus, named severe acute respiratory syndrome coronavirus 2(SARS-CoV-2), was first identified during a recent outbreak in December 2019, Patients with COVID-19 have symptoms of fever, cough, and shortness of breath along with non-specific symptoms including myalgia and fatigue. FB2001 is a small-molecule inhibitor of coronavirus 3CL protease(3CLpro). In phase I clinical trial, FB2001 for Inhalation were safe and tolerable well in healthy subjects, and were projected to be effective in patients according to its pharmacokinetic profile. This study is a double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of FB2001 for Inhalation in patients with mild to moderate Coronavirus Disease 2019 (COVID-19). The subjects will be randomized in a 1:1 ratio to FB2001 group or placebo group while both receiving standard of care treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,336
FB2001 for Inhalation will be reconstituted with normal saline prior to nebulized inhalation. FB2001 will be administered by nebulized inhalation.
FB2001 placebo will be reconstituted with normal saline prior to nebulized inhalation. FB2001 placebo will be administered by nebulized inhalation.
Shenzhen Third People's Hospital
Shenzhen, Guangdong, China
RECRUITINGTime to sustained recovery of COVID-19-related signs/symptoms
Sustained recovery of a COVID-19-related sign/symptom is defined as a COVID-19-related sign/symptom score of 0 for 3 consecutive days, i.e., disappearance of COVID-19-related symptoms or return to the status prior to the onset of COVID-19.
Time frame: Up to Day 29
Proportion of participants who have progression of COVID-19 .
Disease progression is defined as disease severity from mild to moderate or severe or critical, or moderate to severe or critical, or all-cause death
Time frame: Up to Day 29
Time to sustained alleviation of COVID-19-related sign/symptom.
Sustained alleviation of COVID-19-related signs/symptoms are defined as the COVID-19-related sign/symptom score from 0 or 1 to 0 at baseline or from 2 or 3 to 1 or 0 at baseline for 3 consecutive days.
Time frame: Up to Day 29
Time to sustained recovery of 5 key COVID-19-related sign/symptom
Sustained recovery of a COVID-19-related sign/symptom is defined as a COVID-19-related sign/symptom score of 0 for 3 consecutive days, i.e., disappearance of COVID-19-related symptoms or return to the status prior to the onset of COVID-19.
Time frame: Up to Day 29
Time to sustained alleviation of 5 key COVID-19-related sign/symptom
Sustained alleviation of COVID-19-related signs/symptoms are defined as the COVID-19-related sign/symptom score from 0 or 1 to 0 at baseline or from 2 or 3 to 1 or 0 at baseline for 3 consecutive days.
Time frame: Up to Day 29
Proportion of participants who experience sustained recovery of COVID-19 sign/symptom
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no special description
Time frame: Day 3 to Day 21
Proportion of participants who experience sustained alleviation of COVID-19-related sign/symptom
no special description
Time frame: Day 3 to Day 21
Duration of each targeted COVID-19-related sign/symptom.
no special description
Time frame: Up to Day 29
Time to sustained virus clearance of SARS-CoV-2 in nasopharyngeal swabs
no special description
Time frame: Up to Day 29
Changes in SARS-CoV-2 viral load
no special description
Time frame: Up to Day 29
Change in EQ-5D-5L index score
The Euroquol Quality of Life 5-Dimension 5-Level Scale(EQ-5D-5L) index score consists of five dimensions: mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each dimension has five scales: no difficulty, a little difficulty, moderate difficulty, severe difficulty, and very severe difficulty
Time frame: Up to Day 29