A Phase 2 Study to Evaluate the Efficacy and Safety of QLS1128 Orally in Symptomatic Participants With Mild to Moderate COVID-19
NCT ID: NCT05689203
Last Updated: 2023-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
360 participants
INTERVENTIONAL
2022-12-30
2023-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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QLS1128
QLS1128 will be administered orally for 5 days.
QLS1128
dose 1
QLS1128
dose 2
Placebo
Placebo matching to QLS1128 will be administered orally for 5 days.
Placebo
Placebo
Interventions
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QLS1128
dose 1
QLS1128
dose 2
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Qilu Pharmaceutical Co., Ltd.
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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QLS1128-201
Identifier Type: -
Identifier Source: org_study_id
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