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NCT05258643 Clinical Trial

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

Covid19 Clinical Trial

— TONIC  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05258643
Other study ID # 2020/177
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date September 1, 2024

Study information
Verified date April 2021
Source Universitair Ziekenhuis Brussel
Contact Marco Moretti
Phone +32 (0)2477 6001
Email marco.moretti@uzbrussel.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date September 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Blood analysis
Venipuncture and collection of serum and whole blood

Locations
Country Name City State
Belgium UZ Brussel Jette Brussels

Sponsors (1)
Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference in complements or peripheral blood mononuclear cells between CoViD-19 patients and controls up to 1 year
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