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

June 13, 2023 updated by: Maastricht University
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.

Study Overview

Status

Completed

Conditions

Detailed Description

In December 2019, the first cases of coronavirus disease 2019 (COVID-19) were diagnosed in Wuhan, China. Within a couple of weeks, the highly contagious disease spread across the world, requiring rapid and drastic measures, unparalleled in recent decades. Currently, there have been approximately 97.8 million cases, including 2.1 million deaths, reported to the WHO (website accessed January 25th, 2021, https://covid19.who.int). Data from published epidemiology and virologic studies show that the virus is mainly passed on by respiratory droplets, by direct contact with infected people, or by contact with contaminated objects and surfaces. The severity of the disease greatly differs between people. It ranges from non-symptomatic contamination or minor symptoms, such as a cold or sore throat, to life-threatening pneumonia and death. Especially, the elderly population and people with underlying comorbidities are vulnerable and experience more severe symptoms. In addition, studies have shown that males have a higher mortality risk.

COVID-19 is currently diagnosed using reverse-transcription polymerase chain reaction (RT-PCR). In the beginning of the pandemic the use of chest computed tomography (CT) was more common, since CT can capture imaging features from the lung associated with COVID-19 early in the course of the disease. However, performing a CT-can takes remarkably longer than current RT-PCR tests. While the epidemic continues, the consequences are slowly becoming more apparent. As the true population infection rate is unknown, the proportion of patients requiring hospital admission is difficult to estimate. In a meta-analysis including 1481 unique publications a pooled rate of ICU admission of 10.9% and the pooled rate of mortality was 4.3%. The negative effects of an ICU stay strongly depend on the length of the stay and include, but are not limited to, risk of lung emboly, severe muscle loss, dysphagia and psychological problems, often necessitating a long period of rehabilitation.

To minimize long-term health consequences early prognosis of the severity of the disease would be beneficial. The link between the severity of COVID-19 and mitochondrial DNA (mtDNA), Nuclear SNPs, imaging features and radiomics has not been studied yet. However, literature about mechanistic insights in the functioning of the immune system and its link to genetic variation, including mtDNA, are promising. In addition, studies focusing on imaging features and radiomics have yielded interesting findings.

Study Type

Observational

Enrollment (Actual)

394

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
      • Athens, Greece
        • Regional Chest Diseases Hospital of Athens <Sotiria>
  • Italy
      • Firenze, Italy
        • University of Florence
  • Portugal
      • Setúbal, Portugal
        • Centro Hospitalar de Setubal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

Exclusion criteria for hospitalized patients

  • Severe illness other than COVID-19 at hospital admission Exclusion criteria for non-hospitalized patients
  • Severe COVID-19 illness leading to death or requiring active treatment without hospital admission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 Severity
Time Frame: When the patient is discharged from the hospital, up to 2 months
Severity of COVID-19 classified as 'Severe', 'Non-severe' and 'Minor'
When the patient is discharged from the hospital, up to 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival of the hospitalized population
Time Frame: When the patient is discharged from the hospital, up to 2 months
Overall survival of the hospitalized population
When the patient is discharged from the hospital, up to 2 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mitochondrial DNA for prediction of COVID-19 severity
Time Frame: Baseline up to 2 years after having had COVID-19
Mitochondrial DNA variants (extracted from the saliva-sample)
Baseline up to 2 years after having had COVID-19
Nuclear SNPs for prediction of COVID-19 severity
Time Frame: Baseline up to 2 years after having had COVID-19
Nuclear SNPs, candidate approach (extracted from the saliva-sample)
Baseline up to 2 years after having had COVID-19
Radiomic features for COVID-19 severity prediction
Time Frame: Baseline
Radiomics from chest CT-scan of COVID-19 infected participants
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University

Collaborators

Innovative Medicines Initiative

Investigators

  • Principal Investigator: Philippe Lambin, Prof. Dr., Head of Department of Precision Medicine, Maastricht University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

June 12, 2023

Study Completion (Actual)

June 12, 2023

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (Actual)

February 11, 2021

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVIDmtDNA1.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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