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

Qilu Pharmaceutical

Status and phase: Enrolling; Phase 2

Conditions: COVID-19

Treatments: Drug: QLS1128; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05689203

QLS1128-201

Details and patient eligibility

About

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

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 2 patient groups, including a placebo group

QLS1128

Experimental group

Description:

QLS1128 will be administered orally for 5 days.

Treatment:

Drug: QLS1128

Drug: QLS1128

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo