A Phase 2 Study to Evaluate the Efficacy and Safety of QLS1128 Orally in Symptomatic Participants With Mild to Moderate COVID-19

Study Overview
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Brief Summary
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A Phase 2 Study to Evaluate the Efficacy and Safety of QLS1128 Orally in Symptomatic Participants With Mild to Moderate COVID-19

Official Title
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A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of QLS1128 Orally in Symptomatic Participants With Mild to Moderate COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Drug: QLS1128
* Drug: QLS1128
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects between ages of 18-80 years. Confirmed SARS-CoV-2 infection as determined by RT-PCR or antigen test in any specimen collected within 48 hours prior to randomization，first diagnosis of this infection within 72 hours prior to the randomization. Initial onset of the COVID-19-related symptoms/signs within 48 hours prior to the randomization，and at least 1 of the COVID-19-related symptoms/signs (Cough,Shortness of breath or difficulty breathing,fever,Chills,Body pain or muscle pain,Diarrhea,Nausea,Vomiting，Headache，Sore throat，Stuffy or runny nose)present on the day of randomization. Exclusion Criteria: Previous treatment with QLS1128 sustained-release tablets or other 3CL protease inhibitors failed. Has received local approved anti-SARS-CoV-2 drugs within 7 days before screening or plan to receive them during the study period (e.g. paxlovid, azvudine, etc.) Has received monoclonal antibody against SARS-CoV-2 virus within 1 year prior to screening. Has received or expect to receive convalescent plasma therapy for COVID-19 patients during the trial. Has received any CYP3A4/2C8 strong inducer within 28 days prior to screening or plan to receive any CYP3A4/2C8 strong inducer during the study period. A known history of active liver disease , including acute/chronic hepatitis B, hepatitis C, cirrhosis, or acute liver failure. Allergic or have contraindications to test drugs or test drug excipients.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QLS1128<br>QLS1128 will be administered orally for 5 days. | Drug: QLS1128<br>* dose 1<br>Drug: QLS1128<br>* dose 2<br>|
| Placebo Comparator: Placebo<br>Placebo matching to QLS1128 will be administered orally for 5 days. | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline through Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | Baseline through Day 29 | 
| Viral load | Changes of viral load compared to the baseline | 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 | Baseline through Day 15 | 
| All-cause mortality, COVID-19 related mortality | All-cause mortality, COVID-19 related mortality | 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 | Baseline through Day 29 |