COVID-19 and Hereditary Metabolic Diseases

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04645498

Acronym

COVID19-MHM

Enrollment

Registered

2020-11-27

Start date

2021-02-01

Completion date

2023-02-01

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Metabolism, Inborn Errors

Keywords

COVID-19, Inherited metabolic diseases

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORClaire Douillard, MD

University Hospital, Lille

Outcome results