The Role of Natural Killer, Complement and T-lymphocytes in COVID-19 Disease, a Prospective Monocentric Study
TONIC
1 other identifier
interventional
150
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
November 3, 2021
CompletedFirst Posted
Study publicly available on registry
February 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedFebruary 28, 2022
April 1, 2021
3.7 years
November 3, 2021
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
OTHERWhole 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
Controle
OTHERWhole blood and serum samples will be collected during the same period
Interventions
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sabine Allard, PhD
UZ Brussel (Vrije Universiteit Brussel)
- STUDY CHAIR
Joeri Aerts, PhD
Vrije Universiteit Brussel
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