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To evaluate the preliminary efficacy and safety of HH-120 nasal spray in the treatment of asymptomatic or mild COVID-19.
During this study, participants will receive HH-120 nasal spray treatment for 6 consecutive days, the efficacy and safety of HH-120 will be assessed throughout the study period based on viral clearance, clinical recovery, illness severity and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HH-120 group | Experimental | HH-120 Nasal Spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HH-120 Nasal Spray | Biological | HH-120 Nasal Spray 8-10 times per day for 6 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieving SARS-CoV-2 clearance (defined as negative quantitative Real-Time polymerase chain reaction [qRT-PCR] tests taken on two consecutive days). | Median time from first dose to achieving SARS-COV-2 clearance. | Up to 12 days |
| Proportion of participants with SARS-CoV-2 clearance. | Proportion of participants achieving SARS-CoV-2 clearance from the first dose until Day 12. | Up to 12 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical recovery of COVID-19. | Time to sustained COVID-19 symptoms recovery; Time to COVID-19 symptoms improvement; Proportion of participants with sustained COVID-19 symptoms recovery; Proportion of participants with COVID-19 symptoms improvement. | Up to 12 days |
| Viral load. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of the participants who have progression of COVID-19. | Proportion of participants who progress to moderate/severe/critical type of COVID-19 illness. | Up to 12 days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital, Capital Medical University | Beijing | Beijing Municipality | 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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Change of CT values of N gene and ORF1 gene (qRT-PCR) from baseline. |
| Up to 12 days |
| Adverse event. | Incidence and severity of adverse events. | Up to 12 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |