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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05689203
• Other study ID #: QLS1128-201
• Status: Recruiting
• Phase: Phase 2
• Start date: December 30, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: January 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 2 Study to Evaluate the Efficacy and Safety of QLS1128 Orally in Symptomatic Participants With Mild to Moderate COVID-19

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 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 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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• QLS1128
dose 1
• QLS1128
dose 2
• 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	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
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 three consecutive days,or the severity of each COVID-19 symptoms downgrade for three 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	Viral load	Changes of viral load compared to the baseline	Baseline through Day 15
Secondary	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
Secondary	All-cause mortality, COVID-19 related mortality	All-cause mortality, COVID-19 related mortality	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