A Phase 2 Study to Evaluate the Efficacy and Safety of QLS1128 Orally in Symptomatic Participants With Mild to Moderate COVID-19
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
360
Qilu Pharmaceutical Co., Ltd.
Jinan, Shandong, China
RECRUITINGTime to sustained recovery of COVID-19 symptoms
The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 for three consecutive days
Time frame: Baseline through Day 29
Time to sustained alleviation of COVID-19 symptoms
The time from the start of treatment to the time when the severity of 11 COVID-19 symptoms downgrade for three consecutive days
Time frame: Baseline through Day 29
Time to sustained recovery/ alleviation of each COVID-19 symptoms
The time from the start of treatment to the time when each COVID-19 symptoms get scores of 0 for three consecutive days,or the severity of each COVID-19 symptoms downgrade for three consecutive days
Time frame: Baseline through Day 29
Time to sustained recovery/ alleviation/exacerbation of first COVID-19 symptoms
The time from the start of treatment to the time when first COVID-19 symptoms get scores of 0 for three consecutive days,or the severity of first COVID-19 symptoms downgrade for three consecutive days,or the severity of first COVID-19 symptoms deteriorate 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 15
The time when the virus first turn negative and the proportion of patients that the virus turn negative
The time when the virus first turn negative and the proportion of patients that the virus turn negative
Time frame: Baseline through Day 15
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All-cause mortality, COVID-19 related mortality
All-cause mortality, COVID-19 related mortality
Time frame: Baseline through Day 29
The Adverse events
TEAEs associated with drug,SAE associated with drug, adverse events leading to withdrawal, vital signs, physical examination, laboratory examination, 12-lead electrocardiogram, etc
Time frame: Baseline through Day 29