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

NCT ID: NCT04794985

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-17
• Study Completion Date: 2024-08-20

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.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will benefit from participating within this study, because their general health will be evaluated in detail and from a multidimensional perspective. Furthermore, subjects will be informed on their multidimensional health outcomes and will receive a lifestyle advice tailored to their health status. Risks and inconveniences are limited to the time investment associated with the completion of the questionnaires and the study visit. During the study visit various non-invasive measurements as well as minor invasive blood sampling will be performed.

Conditions

Covid19

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VieCuri Medical Centre

OTHER

Sponsor Role: collaborator

Zuyderland Medical Centre

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annemie Schols, PhD

Role: STUDY_DIRECTOR

Maastricht University Medical Centre

Locations

Zuyderland Medical Center

Heerlen, , Netherlands

Maastricht University Medical Center

Maastricht, , Netherlands

VieCuri Medical Center

Venlo, , Netherlands

Countries

Netherlands

Other Identifiers

NL76949.068.21

Identifier Type: -

Identifier Source: org_study_id