COVID-19 and Hereditary Metabolic Diseases (COVID19-MHM)

February 28, 2022 updated by: University Hospital, Lille

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

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lille, France, 59037
        • Recruiting
        • Hop Claude Huriez Chu Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Metabolism, Inborn Errors
Patient affected by an inherited metabolic disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of MHM imbalance triggered by COVID-19
Time Frame: at 8 weeks
disease aggravation or metabolic decompensation, among MHM-infected patients with COVID-19.
at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of COVID-19 patients in Gaucher's disease
Time Frame: at 24 months
at 24 months
Number of COVID-19 patients in Urea Cycle Disorder
Time Frame: at 24 months
at 24 months
Severity of COVID-19 infection
Time Frame: at 24 months
severity of COVID-19 infection as assessed by hospitalization; Intensive Care Unit, death
at 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

November 25, 2020

First Submitted That Met QC Criteria

November 25, 2020

First Posted (Actual)

November 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 28, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020_52
  • 2020-A02886-33 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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