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QLS1128 in symptomatic mild to moderate COVID-19
NCT05758519Phase 3
Key facts
- Status
- Unknown
- Start
- Mar 2023
- Primary completion
- Jun 2023
- Countries
- 1
- Sponsor
- Qilu Pharmaceutical
- Modality
- Small Molecules
- Drugs
- QLS-1128
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 3, randomised, double-blind trial in coronavirus disease 2019 (COVID-19) comparing QLS1128 with Placebo (2 arms). Primary endpoint: Time to sustained recovery of COVID-19 symptoms at Day 29. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
QLS1128
QLS1128 Orally
Placebo
Placebo
03
Who it enrols
Adults 18-80 with confirmed mild to moderate COVID-19 (symptoms <48h, positive test <120h) and risk factors or specific symptoms. Excludes those with recent vaccination (<28 days), prior 3CL inhibitor use, recent mAb use, or severe liver disease.
04
Endpoints
Primary
Time to sustained recovery of COVID-19 symptoms
Secondary
Viral load
Time to sustained recovery/ alleviation of each COVID-19 symptoms
Time to sustained alleviation of COVID-19 symptoms
The time when the virus first turn negative
All-cause mortality, COVID-19 related mortality
WHO 11-point ordinal scale
The Adverse events
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