A Study to Compare QLS1128 With Placebo in Symptomatic Participants With Mild to Moderate COVID-19

NCT05758519 | Unknown Phase 3

• 1 other identifier: QLS1128-301
• Study Type: interventional
• Target: 1,220
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 3 Study to Evaluate the Efficacy and Safety of QLS1128 Orally in Symptomatic Participants With Mild to Moderate COVID-19

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline through Day 29

Secondary Outcomes (8)

• Viral load

  Baseline to Day 4

• Time to sustained recovery/ alleviation of each COVID-19 symptoms

  Baseline through Day 29

• Time to sustained recovery/ alleviation/exacerbation of first COVID-19 symptoms

  Baseline through Day 29

• Time to sustained alleviation of COVID-19 symptoms

  Baseline through Day 29

• The time when the virus first turn negative

  Baseline through Day 29

Study Arms (2)

QLS1128

EXPERIMENTAL

Drug: QLS1128

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

QLS1128 DRUG

QLS1128

QLS1128

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 120 hours prior to randomization.
• Initial onset of the COVID-19-related symptoms/signs within 48 hours prior to the randomization,and any of the following conditions are met on the day of randomization.
• Score ≥2 for at least one symptom of body pain or muscle pain, headache,stuffy or runny nose,sore throat,cough,shortness of breath or difficulty breathing.
• Risk factors associated with progression to severe/critical COVID-19 with a score ≥1 for at least one symptom of fever,muscle or body pain, headache,stuffy or runny nose,sore throat,cough,shortness of breath or difficulty breathing.
• Score ≥1 for fever,with a score ≥1 for at least one symptom of muscle or body pain,headache,stuffy or runny nose,sore throat,cough,shortness of breath or difficulty breathing.

You may not qualify if:

• Previous treatment with QLS1128 sustained-release tablets or other 3CL protease inhibitors failed.
• has received vaccines within 28 days prior to screening or planned to receive vaccines during the study period (including but not limited to COVID-19 vaccine).
• Those who have a history of SARS-CoV-2 infection and still have symptoms related to COVID-19 during the screening period.
• A history of SARS-CoV-2 infection, and the time of diagnosis of the latest infection to the time of diagnosis of the current infection is not more than 28 days.
• Has received local approved anti-SARS-CoV-2 drugs within 7 days before screening or plan to receive them during the study period.
• Has received monoclonal antibody against SARS-CoV-2 virus within 1 year prior to screening.
• Has received convalescent plasma therapy for COVID-19 patients or expect to receive convalescent plasma therapy for COVID-19 patients during the trial.
• Has received any CYP3A4/2C8 strong inducer within 14 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Qilu Pharmaceutical Co., Ltd.

Jinan, Shandong, 10000, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

yunfei ju, M.D.

CONTACT

15053185458; yunfei.ju@qilu-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 7, 2023
• Study Start: March 7, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: March 10, 2023

Record last verified: 2023-03

Locations

CN (1)