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
Brief Summary

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

Detailed Description

Not Provided

Recruiting
COVID-19

Drug: QLS1128

dose 1

Drug: QLS1128

dose 2

Drug: Placebo

Placebo

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
China
Locations

Qilu Pharmaceutical Co., Ltd.
Jinan, Shandong, China

Investigator: yunfei ju, M.D.
Contact: 15053185458
yunfei.ju@qilu-pharma.com

Contacts

yunfei ju, M.D.
15053185458
yunfei.ju@qilu-pharma.com

Not Provided

Qilu Pharmaceutical Co., Ltd.
NCT Number
MeSH Terms
COVID-19