Early-stage Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19

Официальное название

A Multicenter, Open-Label, Randomized Phase 2a Study to Evaluate Safety and Efficacy of Ratutrelvir and Standard of Care in Non-hospitalized Symptomatic Adult Participants With Mild to Moderate COVID-19

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Ratutrelvir (83-0060) non-randomised
  83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)
• Препарат Paxlovid
  Paxlovid (Nirmatrelvir+ Ritonavir , boosted 3CL-protease inhibitor)
• Препарат Ratutrelvir (83-0060)
  83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL)

Первичные конечные точки

• Safety based on adverse events incidence [Срок оценки: 28 days]
• Safety based on adverse events severity [Срок оценки: 28 days]

Вторичные конечные точки (5)

• Efficacy based on Time (days) to sustained recovery of all targeted COVID-19 signs/symptoms through Day 28 [Срок оценки: 28 days]
• Efficacy based on Time to sustained recovery of each targeted COVID-19 symptom through Day 28. [Срок оценки: 28 days]
• PK characteristics of 83-0060 based on Maximum Plasma Concentration (Cmax) [Срок оценки: 11 days]
• PK characteristics of 83-0060 based on Area under the concentration time curve from 0 to time of last quantifiable concentration (AUClast) [Срок оценки: 11 days]
• PK characteristics of 83-0060 based on Time to Cmax ( Tmax) [Срок оценки: 11 days]

Критерии участия

Критерии включения

• Confirmed SARS-CoV-2 infection for 120 h prior to randomization.
• Initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to randomization.
• At least one of the symptoms attributable to COVID-19 present within 24 hours prior to the Day 1 with the severity score of 1 or higher according to the following scoring system for the assessment of severity of:

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 5 центров

• Chonnam National University Hospital — Gwangju
• The Catholic University of Korea, Eunpyeong St. Mary's Hospital — Seoul
• Wonju Severance Christian Hospital — Wŏnju
• Inha University Hospital — Incheon
• Hallym University Sacred Heart Hospital Gangnam — Seoul

Тайвань · 5 центров

• Kaohsiung Medical University Hospital — Kaohsiung City
• Taichung Veterans General Hospital — Taichung
• Taipei Medical University Hospital — Taipei
• Taoyuan General Hospital — Taoyuan
• Chang Gung Memorial Hospital, Linkou Branch — Taoyuan

Австралия · 4 центра

• Novatrial — Charlestown
• Key Health — Sydney
• Momentum Clinical Research Taringa — Brisbane
• Paratus Clinical(Clinical Trials Institute, Torquay) — Torquay

Узбекистан · 1 центр

• Research Institute of Virology — Tashkent

Идентификаторы

NCT: NCT07157007 · 83-0060-0002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗