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This is a randomized, double-blind, placebo-controlled Phase 2 study in participants over the age of 18 years with mild COVID-19. The main purpose of this study is to evaluate the effect on viral load clearance and clinical recovery, and safety of HH-120 nasal spray in participants over the age of 18 years with mild COVID-19 (according to the FDA definition, 2021).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 | Experimental |
| |
| Treatment Group 2 | Experimental |
| |
| Control Group 3 | Placebo Comparator |
| |
| Control Group 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HH-120 nasal spray | Drug | Nasal spray daily doses of HH-120 4 times added on SOC for 6 consecutive days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of viral load compared to the baseline | From baseline to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to sustained clinical recovery of 11 COVID-19 symptoms. | From baseline till Day 28 | |
| Changes of viral load compared to the baseline. | From baseline till Day 28 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100015 | China | ||
| Beijing Friendship Hospital,Capital Medical University |
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| HH-120 nasal spray | Drug | Nasal spray daily doses of HH-120 8 times added on SOC for 6 consecutive days. |
|
| Placebo Comparator | Drug | Nasal spray daily doses of placebo 4 times added on SOC for 6 consecutive days. |
|
| Placebo Comparator | Drug | Nasal spray daily doses of placebo 8 times added on SOC for 6 consecutive days. |
|
| Proportion of participants with moderate, severe, critical COVID-19 disease or death. |
| From baseline till Day 28 |
| Safety assessment: including adverse events, serious adverse events (SAEs), laboratory assessments, etc. | From baseline till Day 28 |
| Beijing |
| Beijing Municipality |
| 100050 |
| China |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
| Mengchao Hepatobiliary Hospital Of Fujian Medical University | Fuzhou | Fujian | 350025 | China |
| The People's Hospital of Gaozhou | Gaozhou | Guangdong | 525200 | China |
| Nanfang Hospital,Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| Xiangtan Central Hospital | Xiangtan | Hunan | 411100 | China |
| Lianyungang Oriental Hospital | Lianyungang | Jiangsu | 222042 | China |
| Yixing People's Hospital | Wuxi | Jiangsu | 214200 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| Panjin Liaoyou Gem flower Hospital | Panjin | Liaoning | 124000 | China |
| Linfen Central Hospital | Linfen | Shanxi | 041000 | China |
| Chengdu Second People's Hospital | Chengdu | Sichuan | 610017 | China |
| Qujing First People's Hospital | Qujing | Yunan | 100000 | China |
| Southern Central Hospital Of Yunnan Province(The First People's Hospital Of Honghe State) | Yisa | Yunnan | 661199 | China |
| Wenzhou Traditional Chinese Medicine Hospital | Wenzhou | Zhejiang | 325000 | China |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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