NCT05813574

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
835

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 28, 2020

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

3.2 years

First QC Date

April 13, 2023

Last Update Submit

November 21, 2024

Conditions

Long COVID-19Post-COVID-19 SyndromeCOVID-19

Outcome Measures

Primary Outcomes (1)

  • General health perception

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

    at 12 months after hospital discharge

Secondary Outcomes (17)

  • Health-related quality of life

    at 3, 6, 9 and 12 months

  • Health Status

    at 3, 6, 9 and 12 months

  • Health Status Scale

    at 3, 6, 9 and 12 months

  • Positive Health

    at 3, 6, 9 and 12 months

  • Incidence, severity and course of Fatique

    at 3, 6, 9 and 12 months

  • +12 more secondary outcomes

Study Arms (1)

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

Interventions

Observational patient reported outcomesOTHER

Of COVID-19 patients

COVID-19 survivors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients (≥18 years old) with SARS-CoV-2 infection confirmed by PCR, and hospitalised and subsequently discharged from MST or ZGT hospital

You may qualify if:

  • Ages ≥18 years
  • PCR-confirmed SARS-CoV-2 infection and hospital admission
  • Proficiency in Dutch
  • Providing informed consent

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medisch Spectrum Twente

Enschede, Overijssel, 7512KZ, Netherlands

Location

Related Publications (2)

  • Wensink M, Schaap G, Ten Klooster PM, Doggen CJM, van der Palen J, Vonkeman HE, Bode C. Physical and mental fatigue in post-COVID syndrome and their associations over time: A small-sample ESM-study to explore fatigue, quality of sleep and behaviours. J Psychosom Res. 2023 Jan;164:111084. doi: 10.1016/j.jpsychores.2022.111084. Epub 2022 Nov 17.

    PMID: 36436226BACKGROUND

  • Schaap G, Wensink M, Doggen CJM, van der Palen J, Vonkeman HE, Bode C. "It Really Is an Elusive Illness"-Post-COVID-19 Illness Perceptions and Recovery Strategies: A Thematic Analysis. Int J Environ Res Public Health. 2022 Oct 11;19(20):13003. doi: 10.3390/ijerph192013003.

    PMID: 36293582BACKGROUND

MeSH Terms

Conditions

Post-Acute COVID-19 SyndromeCOVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Harald E. Vonkeman, PhD

    Medisch Spectrum Twente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

April 13, 2023

First Posted

April 14, 2023

Study Start

July 28, 2020

Primary Completion

October 1, 2023

Study Completion

November 1, 2023

Last Updated

November 25, 2024

Record last verified: 2024-11

Locations

NL(1)