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Long COVID-19NCT05813574

Long Term Impact of COVID-19

An observational study of Long COVID-19 and Post-COVID-19 Syndrome, run by Medisch Spectrum Twente at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Long COVID-19, Post-COVID-19 Syndrome, COVID-19
What is being tested?
Observational patient reported outcomes
How many people
835 participants
Where
1 siteNetherlands
Study dates
28 Jul 2020to 1 Nov 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Medisch Spectrum Twente

    Enschede, Overijssel, 7512KZ

Other trials in Netherlands

About this study

Official title: Long Term Sequelae of COVID-19: Observational Cohort Study in Twente, the Netherlands

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.

Being tested
Observational patient reported outcomes
Medical subject headings
Post-Acute COVID-19 Syndrome, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observational patient reported outcomesOther

    Of COVID-19 patients

Study groups in NCT05813574
Study groupRoleWhat they receive
COVID-19 survivorsCOVID-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).
Receives: Other: Observational patient reported outcomes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. General health perception

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

    Measured: at 12 months after hospital discharge

Secondary outcomes (17)

  1. Health-related quality of life

    measured by Short Form 36 Health Survey (SF-36). Physical role limitations, bodily pain, general health perceptions vitality, social functioning, emotional role limitations and mental health. Min=0, Max=100 where higher scores indicate better health outcomes

    Measured: at 3, 6, 9 and 12 months

  2. Health Status

    measured by EuroQol 5d(EQ-5D). Mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Min = 1, Max = 5, where higher scores indicate worse health outcomes.

    Measured: at 3, 6, 9 and 12 months

  3. Health Status Scale

    Measured by EQ Visual Analogue Scale for self-rated health. Min = 0, Max = 100, where higher scores indicate better health outcomes.

    Measured: at 3, 6, 9 and 12 months

  4. Positive Health

    measured by my Positive Health]): Min = 0, Max = 10, where higher scores indicate better health outcomes

    Measured: at 3, 6, 9 and 12 months

  5. Incidence, severity and course of Fatique

    measured by Short Fatique Questionnaire; min = 4, max = 28, higher scores indicating worse fatigue]

    Measured: at 3, 6, 9 and 12 months

  6. Incidence, severity and course of Dyspnoea

    measured by modified Mental Research Council (mMRC) scale; min = 1, max = 6, higher scores indicating worse dyspnoea

    Measured: at 3, 6, 9 and 12 months

  7. Incidence, severity and course of Sleep

    measured by unvalidated single-item question min = 1, max = 5, higher scores indicating worse sleep

    Measured: at 3, 6, 9 and 12 months

  8. Incidence, severity and course of Post-Traumatic Stress Disorder

    measured by PTSD checklist for th DSM-5 (PCL-5) COVID-19 version

    Measured: at 3, 6, 9 and 12 months

  9. Experience sampling study measuring fatigue

    Fatigue (physical, and mental), 1-7, as single-item with higher scores indicating worse health outcomes

    Measured: Six times a day over 14 days

  10. Experience sampling study measuring dyspnoea

    Dyspnoea (1 - 7), as single-item with higher scores indicating worse health outcomes

    Measured: Six times a day over 14 days

  11. Experience sampling study measuring cognitive functioning

    cognitive functioning, 0 - 10, as single-item with higher scores indicating worse health outcomes

    Measured: Six times a day over 14 days

  12. Experience sampling study measuring pain

    pain (headache, joint pain, chest pain or discomfort, and pain elsewhere/non-specific; 0 - 10, as single-item with higher scores indicating worse health outcomes

    Measured: Six times a day over 14 days

  13. Experience sampling study measuring severity and daily course of positive and negative affect

    Positive (excited, relaxed, satisfied, thankful, and happy) and negative (anxious, gloomy, sad, irritable, and disappointed) affect (all single-items; 1 - 7, higher scores indicating better and worse outcomes for positive and negative affect respectively

    Measured: Six times a day over 14 days

  14. Experience sampling study measuring daily activity

    Type of activity just before measurement; o Options: 1: nothing; 2: strenuous relaxation (for example walking, riding a bike, gardening); 3: passive relaxation (for example watching television, reading a book); 4: sleeping or resting; 5: Work/study; 6: household chores; 7: Eating/drinking; 8: self-care (for example bodily hygiene, medication); 9: On the go; 10: social interaction; 11: Something else, namely…

    Measured: Six times a day over 14 days

  15. Experience sampling study measuring sleep

    Sleep (quality and duration) ; single-item; How many hours of sleep did you get last night?

    Measured: Once a day for 14 days

  16. Experience sampling study measuring naps

    naps (frequency and duration; single-item

    Measured: Once a day for 14 days

  17. Experience sampling study measuring health status

    Self-reported health status (EQ-VAS of the EQ-5D-5L; 0 - 100; higher scores indicating better health outcomes)

    Measured: Once a day for 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2023
  2. Study start28 Jul 2020
  3. Primary completion1 Oct 2023
  4. Study completion1 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
835 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05813574
Sponsor's protocol ID
Long COVID
Status last verified
Nov 2024
First submitted
13 Apr 2023
Last updated
25 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Upon reasonable request

Publications

  • 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.

    PubMed 36436226

  • 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.

    PubMed 36293582

Questions about this trial

What is this clinical trial studying?

An observational study of Long COVID-19 and Post-COVID-19 Syndrome, run by Medisch Spectrum Twente at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

General health perception (time frame: at 12 months after hospital discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05813574, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.

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