- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04793269
Characteristics of Long COVID-19 Syndrome
February 9, 2023 updated by: Christian Clarenbach
Long COVID Syndrom: Charakterisierung Eines Neuen Krankheitsbildes
Characterization of patients with long COVID syndrome including symptoms, medical history and persistent organ damage.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Some people are very hesitant to recover from a COVID-19 infection and present persistent symptoms.
The participants still suffer after the acute phase of the infection from shortness of breath, coughing, chest pain or fatigue.
Therefore, a special interdisciplinary consultation was built.
The consulatation is not only addressed to people who have been hospitalized due to COVID-19, but also to those with mild symptoms during infection.
During the consultation hours, personal health data are collected that serves as the basis for this research project.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Zurich, Switzerland, 8091
- University Hospital Zurich
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with long COVID syndrome
Description
Inclusion Criteria:
- Long COVID syndrome
- age >= 18 years
- Informed consent
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Long COVID
Patients with long COVID syndrome
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspnea
Time Frame: once through study completion, an average of 6 months.
|
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
Time Frame: once through study completion, an average of 6 months
|
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
Time Frame: once through study completion, an average of 6 months
|
assessed by medical interview (reported as yes or no)
|
once through study completion, an average of 6 months
|
Medical history
Time Frame: once through study completion, an average of 6 months
|
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
Time Frame: once through study completion, an average of 6 months
|
Assessed by chest CT, rated as present/not present
|
once through study completion, an average of 6 months
|
Myocardial damage
Time Frame: once through study completion, an average of 6 months
|
Assessed by myocardial damage, rated as present/not present
|
once through study completion, an average of 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Christian F Clarenbach, MD, University Hospital Zurich, Pulmonology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 23, 2021
Primary Completion (ANTICIPATED)
December 31, 2023
Study Completion (ANTICIPATED)
April 30, 2024
Study Registration Dates
First Submitted
March 4, 2021
First Submitted That Met QC Criteria
March 9, 2021
First Posted (ACTUAL)
March 11, 2021
Study Record Updates
Last Update Posted (ACTUAL)
February 10, 2023
Last Update Submitted That Met QC Criteria
February 9, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-00280
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
IPD will be shared on request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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