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.
Phase 1
- Conditions
- Post-acute COVID syndrome(PACS) diagnosis.MedDRA version: 23.0Level: PTClassification code: 10084268Term: COVID-19 Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- CTIS2023-504641-32-00
- Lead Sponsor
- Azienda Ospedaliero Universitaria Di Modena
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
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.
Exclusion Criteria
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method