Clinical trial NCT05758519: A Study to Compare QLS1128 With Placebo in Symptomatic Participants With Mild to Moderate COVID-19
Official title: A Phase 3, 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: PHASE3
Conditions: COVID-19
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-07
Enrollment: 1220
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 3 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 120 hours prior to randomization.
3. Initial onset of the COVID-19-related symptoms/signs within 48 hours prior to the randomization,and any of the following conditions are met on the day of randomization.

   1. Score ≥2 for at least one symptom of body pain or muscle pain, headache,stuffy or runny nose,sore throat,cough,shortness of breath or difficulty breathing.
   2. Risk factors associated with progression to severe/critical COVID-19 with a score ≥1 for at least one symptom of fever,muscle or body pain, headache,stuffy or runny nose,sore throat,cough,shortness of breath or difficulty breathing.
   3. Score ≥1 for fever,with a score ≥1 for at least one symptom of muscle or body pain,headache,stuffy or runny nose,sore throat,cough,shortness of breath or difficulty breathing.

Exclusion Criteria:

1. Previous treatment with QLS1128 sustained-release tablets or other 3CL protease inhibitors failed.
2. has received vaccines within 28 days prior to screening or planned to receive vaccines during the study period (including but not limited to COVID-19 vaccine).
3. Those who have a history of SARS-CoV-2 infection and still have symptoms related to COVID-19 during the screening period.
4. A history of SARS-CoV-2 infection, and the time of diagnosis of the latest infection to the time of diagnosis of the current infection is not more than 28 days.
5. Has received local approved anti-SARS-CoV-2 drugs within 7 days before screening or plan to receive them during the study period.
6. Has received monoclonal antibody against SARS-CoV-2 virus within 1 year prior to screening.
7. Has received convalescent plasma therapy for COVID-19 patients or expect to receive convalescent plasma therapy for COVID-19 patients during the trial.
8. Has received any CYP3A4/2C8 strong inducer within 14 days prior to screening or plan to receive any CYP3A4/2C8 strong inducer during the study period.
9. A known history of active liver disease , including acute/chronic hepatitis B, hepatitis C, cirrhosis, or acute liver failure.
10. 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: Viral load
timeFrame: Baseline to Day 4
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: Time to sustained alleviation of COVID-19 symptoms
timeFrame: Baseline through Day 29
measure: The time when the virus first turn negative
timeFrame: Baseline through Day 29
measure: All-cause mortality, COVID-19 related mortality
timeFrame: Baseline through Day 29
measure: WHO 11-point ordinal scale
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: