NCT05689203

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for phase_2 covid19

Timeline
Completed

Started Dec 2022

Shorter than P25 for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

1 month

First QC Date

January 15, 2023

Last Update Submit

January 15, 2023

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 (7)

  • Time to sustained alleviation of COVID-19 symptoms

    Baseline through Day 29

  • 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

  • Viral load

    Baseline through Day 15

  • The time when the virus first turn negative and the proportion of patients that the virus turn negative

    Baseline through Day 15

  • +2 more secondary outcomes

Study Arms (2)

QLS1128

EXPERIMENTAL

QLS1128 will be administered orally for 5 days.

Drug: QLS1128

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

QLS1128DRUG

dose 1

QLS1128
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 48 hours prior to randomization，first diagnosis of this infection within 72 hours prior to the randomization.
  • 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.

You may not qualify if:

  • Previous treatment with QLS1128 sustained-release tablets or other 3CL protease inhibitors failed.
  • 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.)
  • Has received monoclonal antibody against SARS-CoV-2 virus within 1 year prior to screening.
  • Has received or expect to receive convalescent plasma therapy for COVID-19 patients during the trial.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Pharmaceutical Co., Ltd.

Jinan, Shandong, 10000, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

yunfei ju, M.D.

CONTACT

15053185458yunfei.ju@qilu-pharma.com

Study Design

Study Type
interventional
Phase
phase 2
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

January 15, 2023

First Posted

January 19, 2023

Study Start

December 30, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

January 19, 2023

Record last verified: 2023-01

Locations

CN(1)