COVID-19 and Hereditary Metabolic Diseases

• Conditions: Covid19; Metabolism, Inborn Errors

• Registration Number: NCT04645498
• Lead Sponsor: University Hospital, Lille

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-11-25
• Study First Posted: 2020-11-27
• Study Start: 2021-02-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-02
• Primary Completion: 2023-02
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• 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

Exclusion Criteria

• inability to receive informed information
• Persons deprived of liberty

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of MHM imbalance triggered by COVID-19	at 8 weeks	disease aggravation or metabolic decompensation, among MHM-infected patients with COVID-19.

Secondary Outcome Measures

Name	Time	Method
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	severity of COVID-19 infection as assessed by hospitalization; Intensive Care Unit, death

Trial Locations

Locations (1)

Hop Claude Huriez Chu Lille; 🇫🇷 Lille, France