The Role of Natural Killer, Complement and T-lymphocytes... | NCT05258643

Studies
The Role of Natural Killer, Complement and T-lymphocytes in COVID-19 Disease, a Prospective Monocentric Study

NCT05258643

Sponsor

Universitair Ziekenhuis Brussel

Status

Unknown status

Last Update Posted

Feb 28, 2022Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Complement Abnormality
Peripheral Blood Mononuclear Cells
Covid19

Interventions

Blood analysis

Countries

Belgium

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

Sep 1, 2020Actual

Primary Completion Date

May 1, 2024Estimated

Completion Date

Sep 1, 2024Estimated

First Submitted Date

Nov 3, 2021

First Submission Date that Met QC Criteria

Feb 25, 2022

First Posted Date

Feb 28, 2022Actual

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

Feb 25, 2022

Last Update Posted Date

Feb 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 current study is an open, non-randomized, monocentric, and interventional study. CoViD-19 patients will be recruited at UZ Brussel after informed consent is obtained. Whole blood and serum samples will be collected during acute disease (inclusion and 7 days after inclusion) and during patient follow-up at 2 months after infection.

Sample storage and subsequent use in fundamental research will be performed at VUB Neuro-Aging and Viro-Immunotherapy.

Additionally, medical records of UZ Brussel will be searched and epidemiological, clinical, radiological, and biological data of the selected patients will be obtained at the diagnosis time point and during follow-up.

Healthy volunteers will be recruited as well in the current study, as a comparison arm, after informed consent is obtained.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Covid-19 patients	Other	Whole blood and serum samples will be collected during acute disease (inclusion and 7 days after inclusion) and during patient follow-up at 2 months after infection	Other: Blood analysis
Controle	Other	Whole blood and serum samples will be collected during the same period	Other: Blood analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood analysis	Other	Venipuncture and collection of serum and whole blood	Controle Covid-19 patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in complements or peripheral blood mononuclear cells between CoViD-19 patients and controls		up to 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Covid-19 patients

Inclusion Criteria:

Positive nasopharyngeal reverse transcriptase-polymerase chain reaction for SARS-Coronavirus-02
Signed inform consent

Healthy Volunteers

Inclusion Criteria:

Signed inform consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marco Moretti	Contact	+32 (0)2477 6001		marco.moretti@uzbrussel.be

Overall Officials

Name	Affiliation	Role
Sabine Allard, PhD	UZ Brussel (Vrije Universiteit Brussel)	Study Director
Joeri Aerts, PhD	Vrije Universiteit Brussel	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Brussel	Recruiting	Jette	Brussels Capital	1090	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006403	Hematologic Tests

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided