- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04824495
Evaluation of Inflammatory Cytokines During COVID-19
April 4, 2021 updated by: Daniela Gompelmann, University of Vienna
The aim of this study is to evaluate pro-inflammatory cytokines as well as microvesicles during the course of SARS-CoV2 infection in the context of clinical parameters.
Study Overview
Detailed Description
In this prospective trial, 100 patients with an acute SARS-CoV2 infection are enrolled.
After confirmation of COVID-19, blood samples are taken for evaluation of various inflammatory cyokines and microvesicles at day 1, 5, 9 and 13 during hospitalisation and are interpreted in the context of clinical parameters.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Daniela Gompelmann
- Phone Number: 0043 1 40400 47730
- Email: daniela.gompelmann@meduniwien.ac.at
Study Locations
-
-
-
Vienna, Austria, 1090
- Recruiting
- Medical University of Vienna
-
Contact:
- Daniela Gompelmann
- Phone Number: 0043 1 40400 47730
- Email: daniela.gompelmann@meduniwien.ac.at
-
-
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 confirmed acute SARS-CoV2 infection
Description
Inclusion Criteria:
- Age > 18 years
- Confirmation of acute SARS-CoV2 infection
- Ability to provide informed consent
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 |
|---|---|
|
Patients with acute COVID-19
|
Blood samples at different timepoints during SARS-CoV2 infection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cytokine level in context with clinical parameters
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniela Gompelmann, Medical University of Vienna
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)
January 7, 2021
Primary Completion (Anticipated)
August 31, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
March 29, 2021
First Submitted That Met QC Criteria
March 29, 2021
First Posted (Actual)
April 1, 2021
Study Record Updates
Last Update Posted (Actual)
April 6, 2021
Last Update Submitted That Met QC Criteria
April 4, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Version 1.1, 31.12.2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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