NCT04794985TerminatedNot Applicable

Post-COVID-Health Study: Multidimensional Health Status of COVID-19 Survivors One Year After a SARS-CoV-2 Infection

Maastricht University Medical Center3 sites in 1 country140 target enrollmentStarted: February 17, 2022Last updated: January 16, 2025

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Terminated
Sponsor: Maastricht University Medical Center
Enrollment: 140
Locations: 3
Primary Endpoint: Fat free mass by dual-energy X-ray (DEXA)-scan

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

This study assesses the multidimensional health status of COVID-19 survivors one-year post-infection using validated subjective and objective measures.

Detailed Description

Rationale: Within the Netherlands, more than 1 million people have been infected with SARS-CoV-2, also known as COVID-19. Although the mortality rate is considerable, the vast majority of COVID-19 patients survive the infection. Preliminary findings show that a majority of COVID-19 survivors still experience health problems 3 months after the infection, including reduced lung diffusion capacity, low exercise capacity, muscle weakness, mental problems and reduced cognitive function resulting in a generally poor health status. Whether these health consequences persist on the long-term is unknown.

Objective: To assess the multidimensional health status of COVID-19 survivors one-year post-infection using validated subjective and objective measures.

Study design: A multicenter prospective observational study performed within the MUMC+ and VieCuri Medical Center.

Study population: 200 COVID-19 survivors of the MUMC+, VieCuri Medical Center or Zuyderland Medical Center, both hospitalized (ICU and non-ICU admitted) as well as non-hospitalized patients.

Main study parameters/endpoints: Outcome parameters include objectively and subjectively measured multidimensional health outcomes including physiological and metabolic health, physical capability, cognitive function, psychosocial well-being, social well-being, patient reported outcomes as well as potential determinants of these multidimensional health outcomes (e.g. treatment during/after SARS-CoV-2 infection, vaccination, comorbidities, medication use etc.). Outcomes will be measured during a one-day study visit.

Study Design

Study Type: Observational
Observational Model: Case Only
Time Perspective: Prospective

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•COVID-19 positive based on:
•Confirmed RT-PCR;
•Proven serology for SARS-COV-2 with clearly associated complaints for a SARS-COV-2 infection;
•CO-RADS score of 4 or more with a proven serology for SARS-CoV-2 afterwards.
•Age of ≥18 years;
•Able to provide informed consent;
•Understanding of Dutch language.

Exclusion Criteria

•Patients not willing to participate;
•Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements.