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

Primary Purpose

Complement Abnormality, Peripheral Blood Mononuclear Cells, Covid19

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Blood analysis
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Complement Abnormality

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UZ BrusselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Covid-19 patients

Controle

Arm Description

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

Whole blood and serum samples will be collected during the same period

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 3, 2021
Last Updated
February 25, 2022
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT05258643
Brief Title
The Role of Natural Killer, Complement and T-lymphocytes in COVID-19 Disease, a Prospective Monocentric Study
Acronym
TONIC
Official Title
The Role of Natural Killer, Complement and T-lymphocytes in COVID-19 Disease, a Prospective Monocentric Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complement Abnormality, Peripheral Blood Mononuclear Cells, Covid19

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Covid-19 patients
Arm Type
Other
Arm Description
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
Arm Title
Controle
Arm Type
Other
Arm Description
Whole blood and serum samples will be collected during the same period
Intervention Type
Other
Intervention Name(s)
Blood analysis
Intervention Description
Venipuncture and collection of serum and whole blood
Primary Outcome Measure Information:
Title
Difference in complements or peripheral blood mononuclear cells between CoViD-19 patients and controls
Time Frame
up to 1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marco Moretti
Phone
+32 (0)2477 6001
Email
marco.moretti@uzbrussel.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Allard, PhD
Organizational Affiliation
UZ Brussel (Vrije Universiteit Brussel)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joeri Aerts, PhD
Organizational Affiliation
Vrije Universiteit Brussel
Official's Role
Study Chair
Facility Information:
Facility Name
UZ Brussel
City
Jette
State/Province
Brussels
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Moretti

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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