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

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
QLS1128
QLS1128
Placebo
Sponsored by
Qilu Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female subjects between ages of 18-80 years. 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. 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: Previous treatment with QLS1128 sustained-release tablets or other 3CL protease inhibitors failed. 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.) Has received monoclonal antibody against SARS-CoV-2 virus within 1 year prior to screening. Has received or expect to receive convalescent plasma therapy for COVID-19 patients during the trial. 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. A known history of active liver disease , including acute/chronic hepatitis B, hepatitis C, cirrhosis, or acute liver failure. Allergic or have contraindications to test drugs or test drug excipients.

Sites / Locations

  • Qilu Pharmaceutical Co., Ltd.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

QLS1128

Placebo

Arm Description

QLS1128 will be administered orally for 5 days.

Placebo matching to QLS1128 will be administered orally for 5 days.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
Viral load
Changes of viral load compared to the baseline
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
All-cause mortality, COVID-19 related mortality
All-cause mortality, COVID-19 related mortality
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

Full Information

First Posted
January 15, 2023
Last Updated
January 15, 2023
Sponsor
Qilu Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05689203
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 30, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QLS1128
Arm Type
Experimental
Arm Description
QLS1128 will be administered orally for 5 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matching to QLS1128 will be administered orally for 5 days.
Intervention Type
Drug
Intervention Name(s)
QLS1128
Intervention Description
dose 1
Intervention Type
Drug
Intervention Name(s)
QLS1128
Intervention Description
dose 2
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Time to sustained recovery of COVID-19 symptoms
Description
The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 for three consecutive days
Time Frame
Baseline through Day 29
Secondary Outcome Measure Information:
Title
Time to sustained alleviation of COVID-19 symptoms
Description
The time from the start of treatment to the time when the severity of 11 COVID-19 symptoms downgrade for three consecutive days
Time Frame
Baseline through Day 29
Title
Time to sustained recovery/ alleviation of each COVID-19 symptoms
Description
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
Time Frame
Baseline through Day 29
Title
Time to sustained recovery/ alleviation/exacerbation of first COVID-19 symptoms
Description
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 Frame
Baseline through Day 29
Title
Viral load
Description
Changes of viral load compared to the baseline
Time Frame
Baseline through Day 15
Title
The time when the virus first turn negative and the proportion of patients that the virus turn negative
Description
The time when the virus first turn negative and the proportion of patients that the virus turn negative
Time Frame
Baseline through Day 15
Title
All-cause mortality, COVID-19 related mortality
Description
All-cause mortality, COVID-19 related mortality
Time Frame
Baseline through Day 29
Title
The Adverse events
Description
TEAEs associated with drug,SAE associated with drug, adverse events leading to withdrawal, vital signs, physical examination, laboratory examination, 12-lead electrocardiogram, etc
Time Frame
Baseline through Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects between ages of 18-80 years. 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. 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: Previous treatment with QLS1128 sustained-release tablets or other 3CL protease inhibitors failed. 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.) Has received monoclonal antibody against SARS-CoV-2 virus within 1 year prior to screening. Has received or expect to receive convalescent plasma therapy for COVID-19 patients during the trial. 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. A known history of active liver disease , including acute/chronic hepatitis B, hepatitis C, cirrhosis, or acute liver failure. Allergic or have contraindications to test drugs or test drug excipients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yunfei ju, M.D.
Phone
15053185458
Email
yunfei.ju@qilu-pharma.com
Facility Information:
Facility Name
Qilu Pharmaceutical Co., Ltd.
City
Jinan
State/Province
Shandong
ZIP/Postal Code
10000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yunfei ju, M.D.
Phone
15053185458
Email
yunfei.ju@qilu-pharma.com

12. IPD Sharing Statement

Learn more about this trial

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

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