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A Phase 2 Study to Evaluate the Efficacy and Safety of QLS1128 Orally in Symptomatic Participants With Mild to Moderate COVID-19
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLS1128 | Experimental | QLS1128 will be administered orally for 5 days. |
|
| Placebo | Placebo Comparator | Placebo matching to QLS1128 will be administered orally for 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS1128 | Drug | dose 1 |
| |
| QLS1128 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to sustained alleviation of COVID-19 symptoms | The time from the start of treatment to the time when the severity of 11 COVID-19 symptoms downgrade for three consecutive days | Baseline through Day 29 |
| Time to sustained recovery/ alleviation of each COVID-19 symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yunfei ju, M.D. | Contact | 15053185458 | yunfei.ju@qilu-pharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Pharmaceutical Co., Ltd. | Recruiting | Jinan | Shandong | 10000 | China |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Drug |
dose 2 |
|
| Placebo | Drug | Placebo |
|
The time from the start of treatment to the time when each COVID-19 symptoms get scores of 0 for three consecutive days,or the severity of each COVID-19 symptoms downgrade for three consecutive days |
| Baseline through Day 29 |
| Time to sustained recovery/ alleviation/exacerbation of first COVID-19 symptoms | The time from the start of treatment to the time when first COVID-19 symptoms get scores of 0 for three consecutive days,or the severity of first COVID-19 symptoms downgrade for three consecutive days,or the severity of first COVID-19 symptoms deteriorate for two consecutive days | Baseline through Day 29 |
| Viral load | Changes of viral load compared to the baseline | Baseline through Day 15 |
| The time when the virus first turn negative and the proportion of patients that the virus turn negative | The time when the virus first turn negative and the proportion of patients that the virus turn negative | Baseline through Day 15 |
| All-cause mortality, COVID-19 related mortality | All-cause mortality, COVID-19 related mortality | Baseline through Day 29 |
| The Adverse events | TEAEs associated with drug,SAE associated with drug, adverse events leading to withdrawal, vital signs, physical examination, laboratory examination, 12-lead electrocardiogram, etc | Baseline through Day 29 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |