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This is an Early-stage Clinical Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19. It will also learn about the safety of drug Ratutrelvir. Participants will take a study drug as well as a standard therapy. A descriptive statistics will be used to present the study results.
This is a multicenter, open-label, randomized Phase 2a study to evaluate the safety and efficacy of 83-0060 (Ratutrelvir) and Nirmatrelvir-Ritonavir (Paxlovid) in non-hospitalized symptomatic adult participants with mild to moderate COVID-19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ratutrelvir (83-0060) non-randomised | Experimental |
| |
| Paxlovid | Active Comparator | Standard of care |
|
| Ratutrelvir (83-0060) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ratutrelvir (83-0060) non-randomised | Drug | 83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety based on adverse events incidence | Adverse events incidence will be described using descriptive statistics methods | 28 days |
| Safety based on adverse events severity | Adverse events severity will be assessed by current version of CTCAE | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy based on Time (days) to sustained recovery of all targeted COVID-19 signs/symptoms through Day 28 | 28 days | |
| Efficacy based on Time to sustained recovery of each targeted COVID-19 symptom through Day 28. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
Medical Conditions:
History, current need for hospitalization or anticipated need for hospitalization for the medical treatment of COVID-19.
Urgent or expected need for nasal high-flow oxygen therapy or positive pressure ventilation, invasive mechanical ventilation or ECMO.
Known medical history of active liver disease .
Receiving dialysis or history of moderate to severe renal impairment.
Compromised immune system.
Acute episode of chronic respiratory diseases, including bronchial asthma, chronic obstructive pulmonary disease within 30 days before screening.
Suspected or confirmed concurrent active systemic infection..
Prior/Concomitant Therapy:
Has received or is expected to receive any dose of a SARS-CoV-2 vaccine within 4 months of screening and during the participation in the study.
Concomitant use of any medications or substances that are strong inducers of CYP3A4
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ekaterina Dokukina | Contact | +38269728309 | kdokukina@eilenther.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novatrial | Recruiting | Charlestown | New South Wales | 2290 | Australia |
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Participants will be randomized into 3 study arms (30 participant per arm) to receive study drug and standard of care therapy
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| Paxlovid | Drug | Paxlovid (Nirmatrelvir+ Ritonavir , boosted 3CL-protease inhibitor) |
|
| Ratutrelvir (83-0060) | Drug | 83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL) |
|
| PK characteristics of 83-0060 based on Maximum Plasma Concentration (Cmax) | 11 days |
| PK characteristics of 83-0060 based on Area under the concentration time curve from 0 to time of last quantifiable concentration (AUClast) | 11 days |
| PK characteristics of 83-0060 based on Time to Cmax ( Tmax) | 11 days |
| Key Health | Recruiting | Sydney | New South Wales | 2000 | Australia |
|
| Momentum Clinical Research Taringa | Recruiting | Brisbane | Queensland | 4068 | Australia |
|
| Paratus Clinical(Clinical Trials Institute, Torquay) | Not yet recruiting | Torquay | Victoria | 3228 | Australia |
|
| Chonnam National University Hospital | Not yet recruiting | Gwangju | Donggu | 61469 | South Korea |
|
| The Catholic University of Korea, Eunpyeong St. Mary's Hospital | Not yet recruiting | Seoul | Eunpyeong-gu | 07441 | South Korea |
|
| Wonju Severance Christian Hospital | Not yet recruiting | Wŏnju | Gangwon-do | 26426 | South Korea |
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| Inha University Hospital | Not yet recruiting | Incheon | Jung-gu | 22332 | South Korea |
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| Hallym University Sacred Heart Hospital Gangnam | Not yet recruiting | Seoul | Seoul | 07441 | South Korea |
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| Kaohsiung Medical University Hospital | Not yet recruiting | Kaohsiung City | Kaohsiung | 807 | Taiwan |
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| Taichung Veterans General Hospital | Not yet recruiting | Taichung | Taichung | 407 | Taiwan |
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| Taipei Medical University Hospital | Not yet recruiting | Taipei | Taipei | 110 | Taiwan |
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| Taoyuan General Hospital | Not yet recruiting | Taoyuan | Taoyuan | 33004 | Taiwan |
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| Chang Gung Memorial Hospital, Linkou Branch | Not yet recruiting | Taoyuan | Taoyuan | 333 | Taiwan |
|
| Research Institute of Virology | Recruiting | Tashkent | Tashkent | 100194 | Uzbekistan |
|
| 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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| ID | Term |
|---|---|
| C000719967 | nirmatrelvir and ritonavir drug combination |
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