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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.

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504641-32-00
Acronym
Gero-PACS
Enrollment
60
Registered
2023-07-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-acute COVID syndrome(PACS) diagnosis.

Brief summary

Short Physical Performance Battery, Frailty reversibility, Quality of life assessed with EQ 5D-5L

Detailed description

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)

Interventions

DRUGMETFORMIN
DRUGSIROLIMUS

Sponsors

Azienda Ospedaliero Universitaria Di Modena
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Short Physical Performance Battery, Frailty reversibility, Quality of life assessed with EQ 5D-5L

Secondary

MeasureTime frame
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)

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026