COVID-19
Conditions
Brief summary
A Phase 3 Study to Evaluate the Efficacy and Safety of QLS1128 Orally in Symptomatic Participants With Mild to Moderate COVID-19
Interventions
DRUGQLS1128
QLS1128
DRUGPlacebo
Placebo
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to sustained recovery of COVID-19 symptoms | Baseline through Day 29 | The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 for three consecutive days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to sustained recovery/ alleviation of each COVID-19 symptoms | Baseline through Day 29 | 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 to sustained recovery/ alleviation/exacerbation of first COVID-19 symptoms | Baseline through Day 29 | 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 to sustained alleviation of COVID-19 symptoms | Baseline through Day 29 | The time from the start of treatment to the time when the severity of 11 COVID-19 symptoms downgrade for two consecutive days |
| Viral load | Baseline to Day 4 | Changes of viral load from baseline on Day 4 |
| All-cause mortality, COVID-19 related mortality | Baseline through Day 29 | All-cause mortality, COVID-19 related mortality |
| WHO 11-point ordinal scale | Baseline through Day 29 | Change of WHO 11-point ordinal scale from baseline at different visits |
| The Adverse events | Baseline through Day 29 | TEAEs associated with drug,SAE associated with drug, adverse events leading to withdrawal, vital signs, physical examination, laboratory examination, 12-lead electrocardiogram, etc |
| The time when the virus first turn negative | Baseline through Day 29 | The time when the virus first turn negative |
Countries
China
Contacts
Primary Contactyunfei ju, M.D.
Outcome results
None listed