COVID-19 and Hereditary Metabolic Diseases

NCT04645498 | Unknown

• 2 other identifiers: 2020_522020-A02886-33
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

No additional risk factors have been identified in patients with Inherited Metabolic Diseases (IMD) for contracting or presenting complications of COVID-19 compared to the general population. Yet, IMD patients have cell/tissue alterations that could constitute a potential direct or indirect target for the virus. We do not know the impact of this infection on patients suffering from MHM, nor the possible effect of specific treatment of MHM on the evolution of COVID-19. This study will collect French IMD patients having or having had COVID-19 infection. The main objective is to estimate among IMD patients contracting COVID-19 the frequency of disease aggravation or metabolic decompensation. The secondary objectives will be : a. to evaluate the incidence of COVID-19 diagnosed in a given group of IMD when the number of patients with this IMD is known (Urea Cycle Deficiency, Gaucher Disease). b. to evaluate the impact of IMD on the and severity of COVID-19 infection

Conditions

Covid19; Metabolism, Inborn Errors

Keywords

COVID-19; Inherited metabolic diseases

Outcome Measures

Primary Outcomes (1)

• Frequency of MHM imbalance triggered by COVID-19

  disease aggravation or metabolic decompensation, among MHM-infected patients with COVID-19.

  at 8 weeks

Secondary Outcomes (3)

• Number of COVID-19 patients in Gaucher's disease

  at 24 months

• Number of COVID-19 patients in Urea Cycle Disorder

  at 24 months

• Severity of COVID-19 infection

  at 24 months

Study Arms (1)

Metabolism, Inborn Errors

Patient affected by an inherited metabolic disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

IMD patients followed in reference centers for IMD in France. children and adult patients with MHM who have been infected with COVID-19 (tested positive or considered positive for COVID-19). Asymptomatic MHM patients tested positive for COVID 19 (contact case, for example) will also be studied.

You may qualify if:

• Child or adult patient with a diagnosis of IMD
• Symptomatic or asymptomatic patient tested positive for COVID-19 (PCR and/or serology)
• Symptomatic patient non tested but with strong clinical suspicion for COVID-19
• Patient affiliated with the health insurance

You may not qualify if:

• inability to receive informed information
• Persons deprived of liberty

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

COVID-19; Metabolism, Inborn Errors

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; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Claire Douillard, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire Douillard, MD

CONTACT

0320445962; claire.douillard@chru-lille.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: November 27, 2020
• Study Start: February 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

FR (1)