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This is a multicenter, randomized, double-blind, placebo-parallel-controlled phase III clinical trial. It is designed to evaluate the efficacy and safety of SHEN26 capsules in Chinese adult patients with mild to moderate COVID-19
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHEN26 | Experimental | Participants will receive SHEN26 400mg twice daily for 5 days. |
|
| SHEN26 placebo | Placebo Comparator | Participants will receive SHEN26 placebo twice daily for 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHEN26 capsule | Drug | Capsule administered orally after meals. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to 11 COVID-19 Symptom Resolution by Day 28 | 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 up to 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of viral load compared to the baseline | Baseline, Day 3, and Day 5 | |
| Time to 5 COVID-19 Symptom Resolution by Day 28 | The time from the start of treatment to the time when 5 COVID-19 symptoms get scores of 0 for two consecutive days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dandan Xu | Contact | +8618038100512 | xudandan@kexing.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital Of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 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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| SHEN26 placebo |
| Drug |
Capsule administered orally after meals. |
|
| Day 1 up to 28 |
| Change of viral load compared to the baseline | Baseline, Day 7 |
| Proportion of participants who are negative for SARS-CoV-2 nucleic acid test | baseline, Day 3, Day 5, and Day 7 |
| 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 | Day 1 up to 28 |
| Proportion of Participants with COVID-19 related Hospitalization | Day 1 up to 28 |
| Proportion of severe or critical Participants | Day 1 up to 28 |
| Proportion of Participants with All-cause Death | Day 1 up to 28 |
| AE | Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to 28 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |