COVID-19 and Hereditary Metabolic Diseases

NCT ID: NCT04645498

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2023-02-28

Brief Summary

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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

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Conditions

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Covid19 Metabolism, Inborn Errors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Metabolism, Inborn Errors

Patient affected by an inherited metabolic disease

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire Douillard, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hop Claude Huriez Chu Lille

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Claire Douillard, MD

Role: CONTACT

0320445962 ext. +33

Facility Contacts

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Role: primary

0320445962

Other Identifiers

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2020-A02886-33

Identifier Type: OTHER

Identifier Source: secondary_id

2020_52

Identifier Type: -

Identifier Source: org_study_id

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