A Phase 3 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
1,220
Qilu Pharmaceutical Co., Ltd.
Jinan, Shandong, China
Time 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
Viral load
Changes of viral load from baseline on Day 4
Time frame: Baseline to Day 4
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 two consecutive days,or the severity of each COVID-19 symptoms downgrade for two 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
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 two consecutive days
Time frame: Baseline through Day 29
The time when the virus first turn negative
The time when the virus first turn negative
Time frame: Baseline through Day 29
All-cause mortality, COVID-19 related mortality
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
All-cause mortality, COVID-19 related mortality
Time frame: Baseline through Day 29
WHO 11-point ordinal scale
Change of WHO 11-point ordinal scale from baseline at different visits
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