Clinical trial NCT05689203: A Phase 2 Study to Evaluate the Efficacy and Safety of QLS1128 Orally in Symptomatic Participants With Mild to Moderate COVID-19
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-19
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects between ages of 18-80 years.
2. 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.
3. 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:

1. Previous treatment with QLS1128 sustained-release tablets or other 3CL protease inhibitors failed.
2. 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.)
3. Has received monoclonal antibody against SARS-CoV-2 virus within 1 year prior to screening.
4. Has received or expect to receive convalescent plasma therapy for COVID-19 patients during the trial.
5. 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.
6. A known history of active liver disease , including acute/chronic hepatitis B, hepatitis C, cirrhosis, or acute liver failure.
7. Allergic or have contraindications to test drugs or test drug excipients.

Primary outcomes:
measure: Time to sustained recovery of COVID-19 symptoms
timeFrame: Baseline through Day 29
Secondary outcomes:
measure: Time to sustained alleviation of COVID-19 symptoms
timeFrame: Baseline through Day 29
measure: Time to sustained recovery/ alleviation of each COVID-19 symptoms
timeFrame: Baseline through Day 29
measure: Time to sustained recovery/ alleviation/exacerbation of first COVID-19 symptoms
timeFrame: Baseline through Day 29
measure: Viral load
timeFrame: Baseline through Day 15
measure: The time when the virus first turn negative and the proportion of patients that the virus turn negative
timeFrame: Baseline through Day 15
measure: All-cause mortality, COVID-19 related mortality
timeFrame: Baseline through Day 29
measure: The Adverse events
timeFrame: Baseline through Day 29
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Pharmaceutical Co., Ltd.
state: Shandong
Study officials:
References: