Evaluation of Inflammatory Cytokines During COVID-19 | NCT04824495

Studies
Evaluation of Inflammatory Cytokines During COVID-19

NCT04824495

Sponsor

University of Vienna

Status

Unknown status

Last Update Posted

Apr 6, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Covid19

Interventions

Blood sample

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 7, 2021Actual

Primary Completion Date

Aug 31, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Mar 29, 2021

First Submission Date that Met QC Criteria

Mar 29, 2021

First Posted Date

Apr 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2021

Last Update Posted Date

Apr 6, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with acute COVID-19			Diagnostic Test: Blood sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sample	Diagnostic Test	Blood samples at different timepoints during SARS-CoV2 infection	Patients with acute COVID-19

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cytokine level in context with clinical parameters		2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years
Confirmation of acute SARS-CoV2 infection
Ability to provide informed consent

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with confirmed acute SARS-CoV2 infection

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daniela Gompelmann	Contact	0043 1 40400 47730		daniela.gompelmann@meduniwien.ac.at

Overall Officials

Name	Affiliation	Role
Daniela Gompelmann	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna	Recruiting	Vienna		1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39472409	Derived	Antoniewicz L, Melnikov G, Lyytinen G, Blomberg A, Bosson JA, Hedman L, Mobarrez F, Lundback M. Vascular Stress Markers Following Inhalation of Heated Tobacco Products: A Study on Extracellular Vesicles. Cardiovasc Toxicol. 2025 Jan;25(1):1-8. doi: 10.1007/s12012-024-09934-6. Epub 2024 Oct 29.

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis