Long Term Impact of COVID-19

Sponsor
Medisch Spectrum Twente (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05813574
Collaborator
University of Twente (Other), Ziekenhuisgroep Twente (Other)
835
1
44.1
18.9

Study Details

Study Description

Brief Summary

COVID-19, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, has a devastating effect on human lives, including over 6.6 million death as of November 2022. Furthermore, many individuals continue to experience persisting sequelae after the initial infection. Little is known about the impact of undergoing COVID-19 hospitalisation. Hence, the investigators propose an observational longitudinal study in a cohort of COVID-19 survivors after hospital discharge, to examine their perspectives on their health, health-related quality of life, and persistence of common COVID-19 symptoms, such as fatigue, dyspnoea and anxiety. Potential influencing socio-demographic and biological factors will additionally assessed.

Condition or Disease Intervention/Treatment Phase
  • Other: Observational patient reported outcomes

Study Design

Study Type:
Observational
Actual Enrollment :
835 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Long Term Sequelae of COVID-19: Observational Cohort Study in Twente, the Netherlands
Actual Study Start Date :
Jul 28, 2020
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
COVID-19 survivors

COVID-19 survivors: patients (≥18 years old) who were tested positive for SARS-CoV-2 infection as confirmed by polymerase-chain-reaction (PCR) testing and were subsequently hospitalised, were followed after discharge from hospitals in Enschede (MST), Hengelo or Almelo (ZGT).

Other: Observational patient reported outcomes
Of COVID-19 patients

Outcome Measures

Primary Outcome Measures

  1. General health perception [at 12 months after hospital discharge]

    measured by Short Form 36 Health Survey (SF-36)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Ages ≥18 years

  • PCR-confirmed SARS-CoV-2 infection and hospital admission

  • Proficiency in Dutch

  • Providing informed consent

Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medisch Spectrum Twente Enschede Overijssel Netherlands 7512KZ

Sponsors and Collaborators

  • Medisch Spectrum Twente
  • University of Twente
  • Ziekenhuisgroep Twente

Investigators

  • Principal Investigator: Harald E. Vonkeman, PhD, Medisch Spectrum Twente

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Harald E. Vonkeman, Principle Investigator, Medisch Spectrum Twente
ClinicalTrials.gov Identifier:
NCT05813574
Other Study ID Numbers:
  • Long COVID
First Posted:
Apr 14, 2023
Last Update Posted:
Apr 19, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 19, 2023