NCT05258643

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

February 28, 2022

Status Verified

April 1, 2021

Enrollment Period

3.7 years

First QC Date

November 3, 2021

Last Update Submit

February 25, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difference in complements or peripheral blood mononuclear cells between CoViD-19 patients and controls

    up to 1 year

Study Arms (2)

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

Venipuncture and collection of serum and whole blood

ControleCovid-19 patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Sabine Allard, PhD

    UZ Brussel (Vrije Universiteit Brussel)

    STUDY DIRECTOR
  • Joeri Aerts, PhD

    Vrije Universiteit Brussel

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2021

First Posted

February 28, 2022

Study Start

September 1, 2020

Primary Completion

May 1, 2024

Study Completion

September 1, 2024

Last Updated

February 28, 2022

Record last verified: 2021-04

Locations