A Phase 2 Study to Evaluate the Efficacy and Safety of QLS1128 Orally in SymptomaticParticipants With Mild to Moderate COVID-19
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Drug: QLS1128
dose 1
Drug: QLS1128
dose 2
Drug: Placebo
Placebo
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.
Qilu Pharmaceutical Co., Ltd.
Jinan, Shandong, China
Investigator: yunfei ju, M.D.
Contact: 15053185458
yunfei.ju@qilu-pharma.com
yunfei ju, M.D.
15053185458
yunfei.ju@qilu-pharma.com
Not Provided