Covid19COVID19-MHMNCT04645498
COVID-19 and Hereditary Metabolic Diseases
An observational study of Covid19 and Metabolism, Inborn Errors, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19, Metabolism, Inborn Errors
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2021to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- inability to receive informed information
- Persons deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Covid19, Metabolism, Inborn Errors
- Keywords
- COVID-19, Inherited metabolic diseases
- Medical subject headings
- COVID-19, Metabolism, Inborn Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Metabolism, Inborn Errors | Patient affected by an inherited metabolic disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of MHM imbalance triggered by COVID-19
disease aggravation or metabolic decompensation, among MHM-infected patients with COVID-19.
Measured: at 8 weeks
Secondary outcomes (3)
Number of COVID-19 patients in Gaucher's disease
Measured: at 24 months
Number of COVID-19 patients in Urea Cycle Disorder
Measured: at 24 months
Severity of COVID-19 infection
severity of COVID-19 infection as assessed by hospitalization; Intensive Care Unit, death
Measured: at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start1 Feb 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Douillard, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645498
- Sponsor's protocol ID
- 2020_52
- Other IDs
- 2020-A02886-33
- Acronym
- COVID19-MHM
- Status last verified
- May 2026
- First submitted
- 25 Nov 2020
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04645498
- Acronym / sponsor ID
- COVID19-MHM / 2020_52
- Conditions
- Covid19, Metabolism, Inborn Errors
- Keywords
- COVID-19, Inherited metabolic diseases
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 27 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metabolism, Inborn Errors | – | –Patient affected by an inherited metabolic disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- inability to receive informed information
- Persons deprived of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Number of COVID-19 patients in Gaucher's disease
Time frame: at 24 months
Number of COVID-19 patients in Urea Cycle Disorder
Time frame: at 24 months
Severity of COVID-19 infection
Time frame: at 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Douillard, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Metabolism, Inborn Errors, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of MHM imbalance triggered by COVID-19 (time frame: at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.