A Study to Compare QLS1128 With Placebo in Symptomatic Participants With Mild to Moderate COVID-19

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05758519
• Other study ID #: QLS1128-301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 7, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2023
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: yunfei ju, M.D.
• Phone: 15053185458
• Email: yunfei.ju[@]qilu-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase 3 Study to Evaluate the Efficacy and Safety of QLS1128 Orally in Symptomatic Participants With Mild to Moderate COVID-19

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1220
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• QLS1128
QLS1128
• Placebo
Placebo

Locations

Country	Name	City	State
China	Qilu Pharmaceutical Co., Ltd.	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Viral load	Changes of viral load from baseline on Day 4	Baseline to Day 4
Secondary	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	Baseline through Day 29
Secondary	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
Secondary	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	Baseline through Day 29
Secondary	The time when the virus first turn negative	The time when the virus first turn negative	Baseline through Day 29
Secondary	All-cause mortality, COVID-19 related mortality	All-cause mortality, COVID-19 related mortality	Baseline through Day 29
Secondary	WHO 11-point ordinal scale	Change of WHO 11-point ordinal scale from baseline at different visits	Baseline through Day 29
Secondary	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