COVID19-MHM: COVID-19 and Hereditary Metabolic Diseases

Sponsor

University Hospital, Lille (Other)

Overall Status

Recruiting

CT.gov ID

NCT04645498

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Covid19 Metabolism, Inborn Errors

Study Design

Study Type:

Observational

Anticipated Enrollment :

77 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Metabolism, Inborn Errors Patient affected by an inherited metabolic disease

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hop Claude Huriez Chu Lille	Lille		France	59037

Sponsors and Collaborators

University Hospital, Lille

Investigators

Principal Investigator: Claire Douillard, MD, University Hospital, Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Lille

ClinicalTrials.gov Identifier:

NCT04645498

Other Study ID Numbers:

2020_52
2020-A02886-33

First Posted:

Nov 27, 2020

Last Update Posted:

Mar 2, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Lille

COVID-19

Inherited metabolic diseases

Additional relevant MeSH terms:

COVID-19

Metabolism, Inborn Errors

Metabolic Diseases

Study Results

No Results Posted as of Mar 2, 2022