This Phase Ⅱ/Ⅲ study is to evaluate whether or not there is a difference in time recovery of COVID-19 signs and symptoms through Day 29 between SIM0417/ritonavir and placebo.
The efficacy, safety, and tolerability of SIM0417/ritonavir compared to placebo will be investigated. The exposure to SIM0417 in this population will also be investigated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,208
Time to sustained recovery of 11 COVID-19 symptoms
The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 (absence or return to the status before the onset) for two consecutive days.(Participant-completed study diary (COVID-19 symptoms and signs, and global impression questions))
Time frame: Baseline through Day 29
Time to sustained recovery of 5 COVID-19 symptoms
The time from the start of treatment to the time when 5 COVID-19 symptoms get scores of 0 (absence or return to the status before the onset) or 1 (mild) for two consecutive days.
Time frame: Baseline through Day 29
Time to sustained alleviation of 7 COVID-19 symptoms
The time from the start of treatment to the time when 7 COVID-19 symptoms get scores of 0 (absence or return to the status before the onset) or 1 (mild) for two consecutive days.
Time frame: Baseline through Day 29
Time to sustained alleviation of 11 COVID-19 symptoms
The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 (absence or return to the status before the onset) or 1 (mild) for two consecutive days.
Time frame: Baseline through Day 29
Viral load
Changes of viral load compared to the baseline.
Time frame: Baseline through Day 14
SARS-CoV-2 RNA
Proportion of participants with SARS-CoV-2 RNA below the threshold.
Time frame: Baseline through Day 14
Severe COVID-19 disease
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Hefei First People's Hospital
Hefei, Anhui, China
Beijing Ditan Hospital Captial Medical University
Beijing, Beijing Municipality, China
Chongqing Public Health Medical Center
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Guangzhou Eighth People's Hospital Guangzhou Medical University
Guangzhou, Guangdong, China
Maoming People's Hospital
Maoming, Guangdong, China
Qingyuan People's Hospital
Qingyuan, Guangdong, China
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong, China
Central People's Hospital of Zhanjiang
Zhanjiang, Guangdong, China
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, Guangdong, China
...and 25 more locations
Incidence of disease progression by COVID-19 severity.
Time frame: Baseline through Day 29
Hospitalization or death
Proportion of participants with hospitalization or death from any cause.
Time frame: Baseline through Day 29
ICU stay
Proportion of participants admitted into ICU.
Time frame: Baseline through Day 29
Requiring supplemental oxygen
Proportion of participants requiring supplemental oxygen (low-flow nasal cannula, simple face mask).
Time frame: Baseline through Day 29
Requiring mechanical ventilation/ECMO
Proportion of participants requiring mechanical ventilation/ECMO.
Time frame: Baseline through Day 29
Death (all cause)
Proportion of participants with death (all cause).
Time frame: Baseline through Week 12
WHO clinical progression scale score
Change from baseline in WHO clinical progression scale score.
Time frame: Baseline through Day 29
Time to sustained recovery of each targeted COVID-19 symptom
The time from the start of treatment to the time when each targeted COVID-19 symptom gets scores of 0 (absence or return to the status before the onset) for two consecutive days.
Time frame: Baseline through Day 29
Proportion of sustained recovery of COVID-19 symptoms
Proportion of patients whose symptoms has been sustainedly recovered.
Time frame: Baseline through Day 29
Severity of COVID-19 symptoms
Severity of each COVID-19 symptom.
Time frame: Baseline through Day 29
Composite symptom score
Change from baseline in composite symptom score.
Time frame: Baseline through Day 29
Treatment-Related Adverse Events (TEAEs)
Incidence of Treatment-Related Adverse Events (TEAEs).
Time frame: Baseline through Day 29
Serious Adverse Events (SAEs)
Incidence of Serious Adverse Events (SAEs) Assessed.
Time frame: Baseline through Week 12
The plasma concentration of SIM0417
The trough concentrations of SIM0417.
Time frame: Baseline through Day 5