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This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of GST-HG171/Ritonavir in the treatment of mild to moderate COVID-19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GST-HG171/Ritonavir | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GST-HG171/Ritonavir | Drug | dose of 150 mg GST-HG171 with 100 mg ritonavir |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to sustained clinical recovery of 11 COVID-19 symptoms | The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 for two consecutive days | Day 1 through Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Viral load | Change of viral load compared to the baseline | Baseline through Day 5 |
| Time to sustained clinical recovery of 5 COVID-19 symptoms | The time from the start of treatment to the time when respiratory and feverish symptoms get scores of 0 for two consecutive days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital Of Guangzhou Medical University | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38618202 | Derived | Lu H, Zhang G, Mao J, Chen X, Zhan Y, Lin L, Zhang T, Tang Y, Lin F, Zhu F, Lin Y, Zeng Y, Zhang K, Yuan W, Liang Z, Sun R, Huo L, Hu P, Lin Y, Zhuang X, Wei Z, Chen X, Yan W, Yan X, Mu L, Lin Z, Tu X, Tan H, Huang F, Hu Z, Li H, Li G, Fu H, Yang Z, Chen X, Wang FS, Zhong N. Efficacy and safety of GST-HG171 in adult patients with mild to moderate COVID-19: a randomised, double-blind, placebo-controlled phase 2/3 trial. EClinicalMedicine. 2024 Apr 10;71:102582. doi: 10.1016/j.eclinm.2024.102582. eCollection 2024 May. |
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| ID | Term |
|---|---|
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Placebo |
| Drug |
Placebo |
|
| Day 1 through Day 28 |
| Time to sustained alleviation of 11 COVID-19 symptoms | The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 or 1 for two consecutive days | Baseline through Day 28 |
| Proportion of participants in clinical recovery | Proportion of participants in clinical recovery | Day 1 through Day 28 |
| AE | Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 through Day 28 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |