ISRCTN27106947进行中（未招募）1 期
AGILE master platform protocol - seamless Phase I/IIa platform for the rapid evaluation of candidates for COVID-19 treatment
niversity of Liverpool0 个研究点目标入组 180 人开始时间: 2020年12月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
研究概览
简要总结
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32560744/ protocol (added 03/12/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36272432/ Molnupiravir versus placebo in unvaccinated and vaccinated patients with early SARS-CoV-2 infection in the UK (AGILE CST-2): a randomised, placebo-controlled, double-blind, phase 2 trial (added 24/10/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •The CST protocol inclusion criteria will take precedence over the master protocol inclusion criteria. Patients are eligible to be included in the study only if all of the following criteria apply (as well as all criteria from the appropriate CST protocol):
- •1. Adults (=18 years) with laboratory-confirmed* SARS-CoV-2 infection (PCR)
- •2. Ability to provide informed consent signed by study patient or legally acceptable representative
- •3. Women of childbearing potential (WOCBP, as defined in section 5.5 below) and male patients who are sexually active with WOCBP must agree to use a highly effective method of contraception from the first administration of trial treatment, throughout trial treatment and for the duration outlined in the candidate-specific trial protocol after the last dose of trial treatment
- •*If any CSTs are included in the community setting, the CST protocol will clarify whether patients with suspected SARS-CoV-2 infection are also eligible
- •Standard additional criteria that may be applied per CST protocol:
- •Group A (severe disease)
- •4.1. Patients with clinical status of Grades 5 (hospitalised, oxygen by mask or nasal prongs), 5
- •(hospitalised, on non-invasive ventilation, or high flow oxygen), 7 (hospitalised, intubation and mechanical ventilation, pO2/FiO2 =150 or SpO2/FiO2 =200), 8 (hospitalised mechanical ventilation pO2/FiO2 <150 (SpO2/FiO2 <200) or vasopressors) or 9 (hospitalised, mechanical ventilation pO2/FiO2 <150 and vasopressors, dialysis or ECMO), as defined by the WHO Clinical Progression Scale
- •Group B (mild-moderate disease)
- •4.2. Ambulant or hospitalised patients with the following characteristics peripheral capillary oxygen saturation (SpO2) >94% RA
- •Additional criteria specific to Candidate Specific Trial (CST-2) as of 30/11/2020 are:
- •5. Has signs or symptoms of COVID-19 that began within 5 days of the planned first dose of study drug
- •6. Is in generally good health (except for current respiratory infection) and is free of uncontrolled chronic conditions
- •7. Is willing and able to comply with all study procedures and attending clinic visits through the 4th week
排除标准
- •Patients are excluded from the study if any of the following criteria apply (as well as all criteria from the appropriate CST protocol):
- •1. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >5 times the upper limit of normal (ULN)
- •2. Stage 4 severe chronic kidney disease or requiring dialysis (i.e., estimated glomerular filtration rate <30 ml/min/1.73 m²)
- •3. Pregnant or breastfeeding
- •4. Anticipated transfer to another hospital which is not a study site within 72 hours
- •5. Allergy to any study medication
- •6. Patients taking other prohibited drugs (as outline in CST protocol) within 30 days or 5 times the half-life (whichever is longer) of enrolment
- •7. Patients participating in another CTIMP trial
- •N.B. The CST protocol exclusion criteria will take precedence over the master protocol exclusion criteria.
- •Additional criteria specific to Candidate Specific Trial (CST-2) as of 30/11/2020 are:
- •* The master protocol stipulates ‘Exclusion Criteria 4’ as ‘anticipated transfer to another hospital which is not a study site within 72 hours’. This is not applicable to this protocol as patients are expected to be out-patients.
- •8. Has a febrile respiratory illness that includes pneumonia that result in hospitalisation, or requires hospitalisation, oxygenation, mechanical ventilation, or other supportive modalities.
- •9. Has a platelet count less than 50x109/L.
- •10. Is experiencing adverse events or laboratory abnormalities that are Grade 3 or above based on the CTCAE v5 grading.
- •11. Has clinically significant liver dysfunction or renal impairment.
- •12. Has history of hepatitis C infection or concurrent bacterial pneumonia.
- •13. Has received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 30 days prior to the first dose of study drug.
- •14. In the opinion of the investigator, has significant end-organ disease as a result of relevant comorbidities: chronic kidney disease, congestive heart failure, peripheral vascular disease including diabetic ulcers.
- •15. Has a SaO2 <95% by oximetry or has lung disease that requires supplemental oxygen.
- •16. Has any condition that would, in the opinion of the investigator, put the patient at increased risk for participation in a clinical study.
研究者
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