Genotype and Susceptibility to COVID-19

Active, not recruiting

• Conditions: Covid19
• Interventions: Other: Questionnaire administration,blood sampling and genetic analyses.

• Registration Number: NCT04799834
• Lead Sponsor: Mario Negri Institute for Pharmacological Research

Brief Summary

COVID-19 is a viral disease induced by infection with the novel SARS-CoV-2 coronavirus. Infection arises from the inhalation of viral particles spread by an infected individual. The main virus entry pathways are the nose and mouth mucous membranes, particularly rich in ACE2 receptors, that are used by the virus to enter cells and begin its replication.

Not all individuals who contract the virus fall ill, and most of those who do (about 70-80%) experience mild symptoms (fever, cough, headache, muscle aches, loss of taste and smell). If the immune system is unable to rapidly fight the virus back, the latter can attack the lungs, affeting oxygen absorption inside the alveoli and lead to pneumonia. This more severe form is observed in 20% of patients and can develop into even more serious complications requiring intensive care, with a high mortality rate. In severe cases (about 5%), the disease spreads to the entire body reaching the cardiovascular system and brain, with the risk of heart attacks, encephalitis and stroke, but it can also affect the liver, kidney and bowel.

Reasons why some subjects develop a highly severe disease while others have little or no symptoms at all still remain unclear. Many researchers are trying to find an answer by investigating the human genome, and the Mario Negri laboratories are also working in this direction.

The general hypothesis underlying this research project is that inter-individual genetic variations can explain the different responses to viral infection in a population, and that COVID-19 severity is, therefore, genetically determined in each infected subject.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-30
• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-16
• Primary Completion: 2021-09-20
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-19
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Age > 18 years

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CASES	Questionnaire administration,blood sampling and genetic analyses.	Subjects who have had a severe form of COVID-19 and developed respiratory failure requiring oxygen supplementation or CPAP mechanical ventilation or intubation
CONTROLS 2	Questionnaire administration,blood sampling and genetic analyses.	Subjects, comparable in age, sex and risk factors (such as concomitant pathologies) with the CASES, who did not contract the virus
CONTROLS 1	Questionnaire administration,blood sampling and genetic analyses.	Subjects, comparable in age, sex and risk factors (such as concomitant diseases) with the CASES, who contracted the virus but either did not fall ill or had mild symptoms

Primary Outcome Measures

Name	Time	Method
Identification of genetic factors affecting risk of SARS-Cov-2 infection.	Through study completion, an average of 10 months.
Identification of the genetic determinants of COVID-19 severity.	Through study completion, an average of 10 months.	Identification of variants in one or more candidate gene(s) responsible for the severe manifestation of COVID-19.

Secondary Outcome Measures

Name	Time	Method
Identification of polymorphic variants or mutations affecting treatment response in severe COVID-19 patients.	Through study completion, an average of 10 months.

Trial Locations

Locations (1)

Centro di Ricerche Cliniche per le Malattie Rare "Aldo e Cele Daccò"; 🇮🇹 Ranica, BG, Italy