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WithdrawnNCT04645498COVID19-MHMUpdated May 22, 2026

COVID-19 and Hereditary Metabolic Diseases

An observational study in Covid19 and Metabolism, Inborn Errors, sponsored by University Hospital, Lille. Withdrawn at 1 site in France. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by University Hospital, Lille · Observational

Why this study was withdrawn
Sponsor decision
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Sex
All
01

Study 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

02

Conditions studied

  • Covid19
  • Metabolism, Inborn Errors

Keywords

  • COVID-19
  • Inherited metabolic diseases
03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

Browse COVID-19 studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • inability to receive informed information
  • Persons deprived of liberty
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Metabolism, Inborn Errors

    Patient affected by an inherited metabolic disease

06

What researchers measure

Primary outcomes

  1. Frequency of MHM imbalance triggered by COVID-19

    disease aggravation or metabolic decompensation, among MHM-infected patients with COVID-19.

    Time frame: at 8 weeks

Secondary outcomes

  1. Number of COVID-19 patients in Gaucher's disease

    Time frame: at 24 months

  2. Number of COVID-19 patients in Urea Cycle Disorder

    Time frame: at 24 months

  3. Severity of COVID-19 infection

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

    Time frame: at 24 months

07

Study locations

1 site
  • Hop Claude Huriez Chu Lille
    Lille, 59037, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2021 to primary completion in Feb 2023, 24 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 25, 2020
First posted
Nov 27, 2020
StartActual
Feb 1, 2021
Primary completionActual
Feb 1, 2023
CompletionActual
Feb 1, 2023
Last update
May 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04645498
Responsible party
Sponsor
First posted
Nov 27, 2020
Start date
Feb 1, 2021
Primary completion
Feb 1, 2023
Completion
Feb 1, 2023
Last update
May 22, 2026

Study contacts

Claire Douillard, MD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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