COVID-19 and Hereditary Metabolic Diseases

Covid19 Clinical Trial

— COVID19-MHM  

Official title:

Prospective Study on the Impact of COVID-19 on the Equilibrium of Hereditary Metabolic Disease (MHM) in Patients With or Who Have Contracted COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04645498
• Other study ID #: 2020_52
• Secondary ID: 2020-A02886-33
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: February 2023

Study information

• Verified date: February 2022
• Source: University Hospital, Lille
• Contact: Claire Douillard, MD
• Phone: 0320445962
• Email: claire.douillard[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 77
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Metabolic Diseases
• Metabolism, Inborn Errors

Locations

Country	Name	City	State
France	Hop Claude Huriez Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of MHM imbalance triggered by COVID-19	disease aggravation or metabolic decompensation, among MHM-infected patients with COVID-19.	at 8 weeks
Secondary	Number of COVID-19 patients in Gaucher's disease		at 24 months
Secondary	Number of COVID-19 patients in Urea Cycle Disorder		at 24 months
Secondary	Severity of COVID-19 infection	severity of COVID-19 infection as assessed by hospitalization; Intensive Care Unit, death	at 24 months