NCT04793269

Brief Summary

Characterization of patients with long COVID syndrome including symptoms, medical history and persistent organ damage.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

February 23, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

4.9 years

First QC Date

March 4, 2021

Last Update Submit

March 25, 2025

Conditions

Keywords

long COVIDpost COVID

Outcome Measures

Primary Outcomes (6)

  • Dyspnea

    modified medical research council (scale from 0 to 4). The higher the score the worse the symptoms.

    once through study completion, an average of 6 months.

  • self-addressed Quality of life

    Short form health 36 questionnaire with 8 domains, each rated from 0-100. The higher the score the better subjective quality of life.

    once through study completion, an average of 6 months

  • Thoracic pain

    assessed by medical interview (reported as yes or no)

    once through study completion, an average of 6 months

  • Medical history

    List of relevant morbidities assessed as present/not present by medical interview (e.g. respiratory, cardial, neurological, psychiatric diseases by interview and medical records)

    once through study completion, an average of 6 months

  • Fibrosis

    Assessed by chest CT, rated as present/not present

    once through study completion, an average of 6 months

  • Myocardial damage

    Assessed by myocardial damage, rated as present/not present

    once through study completion, an average of 6 months

Study Arms (1)

Long COVID

Patients with long COVID syndrome

Other: No intervention

Interventions

no intervention

Long COVID

Eligibility Criteria

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

Patients with long COVID syndrome

You may qualify if:

  • Long COVID syndrome
  • age \>= 18 years
  • Informed consent

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Malesevic S, Sievi NA, Baumgartner P, Roser K, Sommer G, Schmidt D, Vallelian F, Jelcic I, Clarenbach CF, Kohler M. Impaired health-related quality of life in long-COVID syndrome after mild to moderate COVID-19. Sci Rep. 2023 May 12;13(1):7717. doi: 10.1038/s41598-023-34678-8.

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christian F Clarenbach, MD

    University Hospital Zurich, Pulmonology

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 11, 2021

Study Start

February 23, 2021

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 30, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

IPD will be shared on request

Locations