Mitochondrial DNA and Nuclear SNPs to Predict Severity of COVID-19 Infection

NCT04750330 | Completed

• 1 other identifier: COVIDmtDNA1.0
• Study Type: observational
• Target: 394
• Locations: 3 countries
• Sites: 3

Brief Summary

In December 2019, the first people got infected with COVID-19 in Wuhan, China. Within weeks, this highly infectious disease spread all over the world. Nearly one year later everyone is still trying to battle this disease and facing the consequences it causes. What became clear is that the disease and its severity differs largely between infected people. However, knowledge about who will experience severe COVID-19 and who does not is still unclear. Therefore, the aim of this study is to investigate the prognostic value of certain parameters (mtDNA and CT radiomics signature) for the severity of COVID-19.

Conditions

Covid19

Keywords

COVID-19; Severity; mtDNA; SARS-CoV-2 Infection; Radiomics

Outcome Measures

Primary Outcomes (1)

• COVID-19 Severity

  Severity of COVID-19 classified as 'Severe', 'Non-severe' and 'Minor'

  When the patient is discharged from the hospital, up to 2 months

Secondary Outcomes (1)

• Overall survival of the hospitalized population

  When the patient is discharged from the hospital, up to 2 months

Other Outcomes (3)

• Mitochondrial DNA for prediction of COVID-19 severity

  Baseline up to 2 years after having had COVID-19

• Nuclear SNPs for prediction of COVID-19 severity

  Baseline up to 2 years after having had COVID-19

• Radiomic features for COVID-19 severity prediction

  Baseline

Study Arms (3)

Severe COVID-19

Patients, diagnosed with COVID-19, who were admitted to the Intensive Care Unit (ICU) during hospitalisation

Non-severe COVID-19

Patients, diagnosed with COVID-19, who were admitted to the hospital but NOT to the Intensive Care Unit (ICU) during hospitalisation

Minor COVID-19

Patients, diagnosed with COVID-19, who were NOT admitted to the hospital and could recover at home

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients, diagnosed with COVID-19 in the period ranging from December 2019 until December 2022. The case cohort consists of patients, who were admitted to the hospital ICU. The control group consists of patients, who were not admitted to the hospital or admitted to the hospital but not to the ICU.

You may qualify if:

• Confirmed COVID-19 disease
• Age at least 18 years
• Willing and able to provide a saliva sample
• Able to understand the patient study information
• Signed informed consent

You may not qualify if:

• Severe COVID-19 illness leading to death or requiring active treatment without hospital admission

Sponsors & Collaborators

• Maastricht University: lead
• Innovative Medicines Initiative: collaborator

Study Sites (3)

Regional Chest Diseases Hospital of Athens <Sotiria>

Athens, Greece

Location

University of Florence

Florence, Italy

Location

Centro Hospitalar de Setúbal

Setúbal, Portugal

Location

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Related Links

• European Radiology
• WHO Coronavirus Disease (COVID-19) Dashboard

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples will be collected for analysis of * Mitochondrial DNA variants * Nuclear SNPs, candidate approach In case blood samples are present already they can be used instead of saliva. However, patients will never be asked to have (extra) blood samples to be collected if those samples aren't present. If no samples are present they'll be asked to collect saliva.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Philippe Lambin, Prof. Dr.

  Head of Department of Precision Medicine, Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 11, 2021
• Study Start: April 1, 2021
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

GR (1); IT (1); PT (1)