2023-504641-32-00撤回2 期
A geroscience approach to post-acute COVID-19 syndrome (PACS) by Diet and Exercise plus rapamycin or metformin to treat Frailty and restore immune functions: a randomized, single center clinical trial.
Azienda Ospedaliero Universitaria Di Modena1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年7月13日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Short Physical Performance Battery
研究概览
简要总结
The AIM 1 of the project is to compare two years lifestyles intervention alone or in association with metformin or rapamycin pulse therapy in changing aging trajectories depicted by by an improvement of physical performance assessed by SPPB score as continous variable in people with PACS.
研究设计
- 分配方式
- Randomized
- 主要目的
- Gero-pacs
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Confirmed PACS diagnosis according to WHO definition by two consecutive clinical assessment
- •Previous hospital admission for Severe COVID Pneumonia
- •Age 40-80 years
- •Frailty or pre-frailty status performed with frailty phenotype criteria
- •Independently mobile
- •Able and willing to provide written consent.
排除标准
- •Previous or current use of metformin
- •Diabetes history or diagnosis at baseline
- •Transplant or cancer requiring chemotherapy
- •History of chronic kidney disease (eGFR<30 mil/min)
- •Allergies to metformin or rapamycin
- •Female participant pregnant or breastfeeding
- •Baseline SPPB score <3
- •Life expectancy <6 months
结局指标
主要结局
Short Physical Performance Battery
Short Physical Performance Battery
Frailty reversibility
Frailty reversibility
Quality of life assessed with EQ 5D-5L
Quality of life assessed with EQ 5D-5L
次要结局
- Identification of the main changes in peripheral blood cells that identify the immune risk phenotype (CD4/CD8 T cell ratio, senescent/activated CD8+ T cells, number of B lymphocytes and NK cells)
- Evaluation of the change that occur in the plasma level of the main inflammatory and anti-inflammatory cytokines, chemokines and their receptors.
- Analysis of the differences in monocyte activation and phenotypes (inflammatory, classical, non classical) among groups
- The occurrence of adverse events (AEs), changes on clinical examination including vital signs and weight, and laboratory examinations (biochemistry, hematology and urinalysis)
研究者
Giovanni Guaraldi
Scientific
Azienda Ospedaliero Universitaria Di Modena
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
A geroscience approach to post-acute COVID-19 syndrome (PACS) by Diet and Exercise plus rapamycin or metformin to treat Frailty and restore immune functions: a randomized, single center clinical trial.CTIS2023-504641-32-00Azienda Ospedaliero Universitaria Di Modena60
已完成
不适用
eurofeedback for treatment of post-COVID-19 complicationsISRCTN49037874Charles University17
已完成
不适用
ife AfTER COVID-19 (LATER-19) - an observational studyACTRN12621001067864South Metropolitan Health Service344
尚未招募
Unknown
Survey on long-term post COVID-19 health condition after COVID-19 infectioCOVID-19JPRN-UMIN000051964ational Center for Global Health and Medicine1,000
已完成
不适用
ASAP - Assisted Immediate Augmented Post-/Long-COVID Plan for Patients Infected With COVID-19Long-COVIDPost-COVIDPsychosomatic DisorderPsychological DistressPsychological DiseasePsychological DisorderPsychological ImpairmentPsychological AdjustmentPhysiological DiseasePhysiological DisorderPhysiological ImpairmentPhysiological AdjustmentHealthy LifestyleNCT05238415Prof. Dr. Sonia Lippke192