Approaches and Metrics in Fraily Patients During COVID-19 Era

NCT05792891 | Completed

• 1 other identifier: RS1446
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

The COVID-19 pandemic started in December 2019 in Wuhan, the Chinese province of Hubei. Compared to the period of the first epidemic wave (March to May 2020), in the period of the second epidemic wave (October 2020 to July 2021), deceased people have a more significant clinical complexit, as demonstrated by the higher number of comorbidities.The need to allocate significant amounts of healthcare resources to the COVID-19 emergency, deferral of routine healthcare visits, and invitation to avoid medical controls, if not strictly necessary, may have led to interruptions of disease management undersupply of chronic treatments. Consequently, the health status of patients with chronic pathologic conditions have worsened during and beyond the crisis. Patients with cancer, autoimmune disease, and immune deficiencies represented populations with varying immunocompetence, which made translate into higher susceptibility to SARS-CoV-2 and, for this reason, we defined them as frail populations.The main goal of the study was to propel the field of COVID-19 impact on particularly vulnerable categories of patients. The findings of this study could aid in determining the conditions under which healthcare organizations must operate in the event of a pandemic in order to protect patient's rights to care.

Conditions

Frailty; Oncology; Immune Deficiency

Outcome Measures

Primary Outcomes (1)

• Develop general guidelines for clinical care of frail patients

  Presence or not of SARS-COV2 infection Presence of specific tumor or HIV-1 infection or psoriasis

  18 months

Study Arms (2)

Covid-19 patients

Other: Collecting biological material from frail patients, with or without COVID-19

No Covid-19 patients

Other: Collecting biological material from frail patients, with or without COVID-19

Interventions

Collecting biological material from frail patients, with or without COVID-19 OTHER

The study planned to collect demographic information, disease history, COVID-19 symptomatology, COVID-19 molecular test details, COVID-19 serological test results, and biobanking of biological specimens (PBMCs, sera, plasma). In addition, clinical analyses, anamnestic data, and pharmacological treatment pieces of information were collected.

Covid-19 patients; No Covid-19 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Frail populations (patients with cancer, autoimmune disease, and immune deficiencies)

You may qualify if:

• Written informed consent for participation in the study
• In the period between April 1, 2021, and September 31, 2022, all COVID-19 positive frail patients identified by molecular swabs taken at participating institutions were included in the study; ii) on a quarterly basis, a cohort of equal numbers of COVID-19 negative frail patients wre identified and paired by disease , gender, and age.

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (2)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

Location

Regina Elena Cancer Institute

Rome, 00144, Italy

Location

Related Publications (1)

• Silvestris N, Belleudi V, Addis A, Pimpinelli F, Morrone A, Sciacchitano S, Mancini R, Garrisi VM, Costantini M, Ciliberto G, Frisardi V, Piaggio G. Development of Approaches and Metrics to Measure the Impact and Improve the Clinical Outcomes of Patients With Frailty in the Era of COVID-19. The COMETA Italian Protocol. Front Oncol. 2022 Jun 2;12:828660. doi: 10.3389/fonc.2022.828660. eCollection 2022.

  PMID: 35756683 RESULT

MeSH Terms

Conditions

Frailty; Neoplasms; Immunologic Deficiency Syndromes

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: March 31, 2023
• Study Start: December 22, 2020
• Primary Completion: February 15, 2021
• Study Completion: November 23, 2022
• Last Updated: May 8, 2023

Record last verified: 2023-03

Locations

IT (2)