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The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) Compared With Paxlovid for the Treatment of Coronavirus Disease 2019 (COVID-19) in Participants With Mild to Moderate COVID-19.
Screening Interested participants will sign the appropriate informed consent form (ICF) prior to completion of any study procedures.
The investigator will review symptoms, risk factors and other non-invasive inclusion and exclusion criteria prior to any invasive procedures.
Treatment and Assessment Period
This is the general sequence of events during the 28-day treatment and assessment period:
Complete baseline procedures Participants are randomized to an intervention group Participants receive study intervention (Q12H X 5 days), and Complete all safety monitoring
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JT001(VV116) | Experimental | Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days |
|
| Paxlovid | Active Comparator | Day 1~5: 300 mg of Nirmatrelvir and 100 mg of ritonavir, Q12H X 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JT001 | Drug | Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to sustained clinical recovery | Time to sustained clinical recovery up to 28 days. | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| AEs and SAEs through Day 28 | AEs and SAEs through Day 28 | Up to 28 days |
| Percentage of participants who experience these events by Day 28 | Percentage of participants who experience these events by Day 28 Progress to severe and/or critical COVID-19; Death from any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guang Ning | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200020 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36577095 | Derived | Cao Z, Gao W, Bao H, Feng H, Mei S, Chen P, Gao Y, Cui Z, Zhang Q, Meng X, Gui H, Wang W, Jiang Y, Song Z, Shi Y, Sun J, Zhang Y, Xie Q, Xu Y, Ning G, Gao Y, Zhao R. VV116 versus Nirmatrelvir-Ritonavir for Oral Treatment of Covid-19. N Engl J Med. 2023 Feb 2;388(5):406-417. doi: 10.1056/NEJMoa2208822. Epub 2022 Dec 28. |
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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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| ID | Term |
|---|---|
| C000722705 | GS-621763 |
| C000719967 | nirmatrelvir and ritonavir drug combination |
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Parallel
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| Paxlovid | Drug | Day 1~5: 300 mg of Nirmatrelvir and 100 mg of ritonavir, Q12H X 5 days |
|
|
| Day 1 to 28 days |
| Percentage of clinical recovery participants | Percentage of clinical recovery participants from baseline to Days 3, 5, 7, 10, 14, 21 and 28 | Days 3, 5, 7, 10, 14, 21 and 28 |
| The change of COVID-19 symptom scores | The change of "COVID-19 symptom scores" from baseline to Days 3, 5, 7, 10, 14, 21 and 28, the score ranges from 0 to 33 and higher scores mean a worse symptom. | Days 3, 5, 7, 10, 14, 21 and 28 |
| The change of WHO clinical progression scale | The change of "WHO clinical progression scale" from baseline to Days 3, 5, 7, 10, 14, 21 and 28, the score ranges from 0 to 10 and higher scores mean a worse clinical progression. | Days 3, 5, 7, 10, 14, 21 and 28 |
| Percentage of participants with SARS-CoV-2 clearance | Percentage of participants with SARS-CoV-2 clearance on Days 3, 5, 7, 10 and 14 | Days 3, 5, 7, 10, 14 |
| The change of SARS-COV-2 Ct value | The change of SARS-COV-2 Ct value at Days 3, 5, 7, 10, 14 | Days 3, 5, 7, 10, 14 |
| The change of Chest CT scan | The change of Chest CT scan from baseline to Days 7 or 10. The change from baseline involves not changed, getting worse, getting better as assessed by the investigator. | Days 7 or 10 |
| Percentage of the participants who have progression of COVID-19 though Day 28 | Progress to severe and/or critical COVID-19; Death from any cause | Up to 28 days |
| Percentage of participants whose "WHO clinical progression scale" reduced at least one level | Percentage of participants whose "WHO clinical progression scale" reduced at least one level from baseline to Days 3, 5, 7, 10, 14, 21 and 28. The score ranges from 0 to 10 and the higher scores mean a worse clinical progression level. | Days 3, 5, 7, 10, 14, 21 and 28 |
| Time to sustained clinical symptom resolution | Time to sustained clinical symptom resolution | Up to 28 days |
| Percentage of participants with clinical symptom resolution | Percentage of participants with clinical symptom resolution from baseline to Days 3, 5, 7, 10, 14, 21 and 28 | Days 3, 5, 7, 10, 14, 21 and 28 |
| Shanghai Tongren Hospital |
| Shanghai |
| Shanghai Municipality |
| 200050 |
| China |
| Shanghai Public Health Clinical Center | Shanghai | Shanghai Municipality | 200093 | China |
| Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200127 | China |
| ShuGuang Hospital | Shanghai | Shanghai Municipality | 201203 | China |
| Shanghai Pudong Hospital | Shanghai | Shanghai Municipality | 201399 | China |
| Huashan Hospital affiliated to Fudan University | Shanghai | Shanghai Municipality | 201900 | China |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |