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
About this trial
This is an interventional basic science trial for Complement Abnormality
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
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
NCT ID
NCT05258643
First Posted
November 3, 2021
Last Updated
February 25, 2022
Sponsor
Universitair Ziekenhuis Brussel
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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