Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of RAY1216 tablets in the treatment of mild to moderate SARS-CoV-2 infection. The total study duration is up to 28 days.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAY1216 | Experimental | Participants received 400mg RAY1216 tablet orally three times daily for 5 days. |
|
| Placebo | Placebo Comparator | Participants received 400mg placebo orally three times daily for 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAY1216 | Drug | RAY1216(tablet) |
| |
| Placebo |
| 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 three consecutive days. | Day 1 through Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who experience hospitalization or death cause by progression to severe disease | Day 1 through Day 29 | |
| Proportion of participants who experience death from any cause | Day 1 through Day 29 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital Of Guangzhou Medical University | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38188690 | Derived | Zhan Y, Lin Z, Liang J, Sun R, Li Y, Lin B, Ge F, Lin L, Lu H, Su L, Xiang T, Pan H, Huang C, Deng Y, Wang F, Xu R, Chen D, Zhang P, Tong J, Wang X, Meng Q, Zheng Z, Ou S, Guo X, Yao H, Yu T, Li W, Zhang Y, Jiang M, Fang Z, Song Y, Chen R, Luo J, Kang C, Liang S, Li H; other Collaborative Institutes; Zheng J, Zhong N, Yang Z. Leritrelvir for the treatment of mild or moderate COVID-19 without co-administered ritonavir: a multicentre randomised, double-blind, placebo-controlled phase 3 trial. EClinicalMedicine. 2023 Dec 14;67:102359. doi: 10.1016/j.eclinm.2023.102359. eCollection 2024 Jan. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
placebo (tablet) |
|
| Proportion of participants who experience COVID-19 related hospitalization or death from any cause | Day 1 through Day 29 |
| SARS-CoV-2 viral shedding time in nasopharyngeal swabs | baseline, Day 4, Day 6, Day 10, Day 15 |
| Change of viral load compared to the baseline | baseline, Day 4, Day 6, Day 10, Day 15 |
| Proportion of participants who are negative for SARS-CoV-2 nucleic acid test | baseline, Day 4, Day 6, Day 10, Day 15 |
| Time to clinical sustained remission | Day 1 through Day 29 |
| Proportion of participants in clinical recovery/remission | Day 1 through Day 29 |
| Time to sustained clinical recovery of 10 COVID-19 symptoms except cough | Day 1 through Day 29 |
| Time to sustained clinical recovery of COVID-19 respiratory and systemic symptoms | Day 1 through Day 29 |
| Time to sustained clinical recovery of each COVID-19 targeted symptoms | Day 1 through Day 29 |
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 through Day 29 |