Hypohidrotic Ectodermal DysplasiaPEDCOVID-19NCT04741412
Pediatric SARS-CoV-2 Infections: Course of COVID-19, Immune Responses, Complications and Long-term Consequences
An observational study of Hypohidrotic Ectodermal Dysplasia, run by University Hospital Erlangen at 1 site in Germany.
Trial summary
Longitudinal study of 56 households with at least one member who had COVID-19 to compare the course of illness, immune responses, and long-term consequences of SARS-CoV-2 infection in HED patients with those of control subjects of the same age group. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypohidrotic Ectodermal Dysplasia
- How many people
- 231 participants
- Where
- 1 siteGermany
- Study dates
- 3 Jun 2020to 31 May 2021
- How long will I take part?
- 6 Months
- 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: households with children and/or adolescents and at least one member who has or had a SARS-CoV-2 infection
Who may be able to join
- household with one or more members registered as patient(s) in the University Hospital Erlangen
- at least one person <18 years of age
- at least one household member who has or had a SARS-CoV-2 infection confirmed by a positive PCR test, detection of specific antibodies against this virus, or by development of COVID-19 symptoms after being in close contact with a person known to be infected with SARS-CoV-2
- informed consent
Who cannot join
- missing informed consent of one or more household members
- language barriers to communication that would prevent informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SARS-CoV-2 Infections in Children and Adolescents: Course of COVID-19, Immune Responses, Complications and Long-term Consequences in Entire Households With Members Younger Than 18 Years
Longitudinal study of 56 households with at least one member who had COVID-19 to compare the course of illness, immune responses, and long-term consequences of SARS-CoV-2 infection in HED patients with those of control subjects of the same age group. Complete households are investigated, including women who are pregnant when exposed to the virus and their newborn child(ren).
- Conditions
- Hypohidrotic Ectodermal Dysplasia
- Medical subject headings
- Ectodermal Dysplasia 1, Anhidrotic
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 |
|---|---|---|
| Hypohidrotic Ectodermal Dysplasia | all household members with hypohidrotic ectodermal dysplasia (HED), a rare hereditary developmental disorder | |
| Control | individuals of the same age group, but without HED, including pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
age-dependence of SARS-CoV-2 infection
registry of household members with and without symptoms of COVID-19 (entire households)
Measured: 3 months from the point in time at which the first household member shows symptoms of COVID-19
percentage of household members infected by SARS-CoV-2
The infection rate is determined on the basis of specific PCR tests and detectibility of antibodies against SARS-CoV-2.
Measured: 3 months from the point in time at which the first household member shows symptoms of COVID-19
duration of primary COVID-19 symptoms
The possible association between the length of time with symptoms of COVID-19 and specific immune responses, in particular the development of virus-neutralizing antibodies, is studied.
Measured: 2 months from the onset of COVID-19 symptoms
frequency of late-onset cardiovascular complications
Patient-reported known and yet unknown long-term consequences of COVID-19 are registered and investigated further (questionnaire, specific data confirmed by clinical examination).
Measured: 2-12 months from the onset of COVID-19 symptoms
frequency of postviral fatigue
Patient-reported symptoms of fatigue are registered (questionnaire).
Measured: 2-12 months from the onset of COVID-19 symptoms
frequency of noticeable temporary hair loss after COVID-19
Patient-reported extent of hair loss is registered (questionnaire).
Measured: 2-12 months from the onset of COVID-19 symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start3 Jun 2020
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypohidrotic Ectodermal DysplasiaStudies of the same condition, open and under way.
- 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
- 231 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospital Erlangen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Holm Schneider, University Hospital Erlangen
- Investigators
- Holm Schneider, MD, Principal investigator, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741412
- Sponsor's protocol ID
- 212_20 B
- Acronym
- PEDCOVID-19
- Status last verified
- Aug 2021
- First submitted
- 1 Feb 2021
- Last updated
- 16 Aug 2021
- 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 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 Infections in Children and Adolescents: Course of COVID-19, Immune Responses, Complications and Long-term Consequences in Entire Households With Members Younger Than 18 Years
- ClinicalTrials.gov ID
- NCT04741412
- Acronym / sponsor ID
- PEDCOVID-19 / 212_20 B
- Conditions
- Hypohidrotic Ectodermal Dysplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- University Hospital ErlangenUniversity, hospital or other
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 5 Feb 2021 (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.
Longitudinal study of 56 households with at least one member who had COVID-19 to compare the course of illness, immune responses, and long-term consequences of SARS-CoV-2 infection in HED patients with those of control subjects of the same age group. Complete households are investigated, including women who are pregnant when exposed to the virus and their newborn child(ren).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypohidrotic Ectodermal Dysplasia | – | –all household members with hypohidrotic ectodermal dysplasia (HED), a rare hereditary developmental disorder |
| Control | – | –individuals of the same age group, but without HED, including pregnant women |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- households with children and/or adolescents and at least one member who has or had a SARS-CoV-2 infection
Key inclusion criteria (4 listed)
- household with one or more members registered as patient(s) in the University Hospital Erlangen
- at least one person <18 years of age
- at least one household member who has or had a SARS-CoV-2 infection confirmed by a positive PCR test, detection of specific antibodies against this virus, or by development of COVID-19 symptoms after being in close contact with a person known to be infected with SARS-CoV-2
- informed consent
Key exclusion criteria (2 listed)
- missing informed consent of one or more household members
- language barriers to communication that would prevent informed consent
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
age-dependence of SARS-CoV-2 infection
Time frame: 3 months from the point in time at which the first household member shows symptoms of COVID-19
registry of household members with and without symptoms of COVID-19 (entire households)
percentage of household members infected by SARS-CoV-2
Time frame: 3 months from the point in time at which the first household member shows symptoms of COVID-19
The infection rate is determined on the basis of specific PCR tests and detectibility of antibodies against SARS-CoV-2.
duration of primary COVID-19 symptoms
Time frame: 2 months from the onset of COVID-19 symptoms
The possible association between the length of time with symptoms of COVID-19 and specific immune responses, in particular the development of virus-neutralizing antibodies, is studied.
frequency of late-onset cardiovascular complications
Time frame: 2-12 months from the onset of COVID-19 symptoms
Patient-reported known and yet unknown long-term consequences of COVID-19 are registered and investigated further (questionnaire, specific data confirmed by clinical examination).
frequency of postviral fatigue
Time frame: 2-12 months from the onset of COVID-19 symptoms
Patient-reported symptoms of fatigue are registered (questionnaire).
frequency of noticeable temporary hair loss after COVID-19
Time frame: 2-12 months from the onset of COVID-19 symptoms
Patient-reported extent of hair loss is registered (questionnaire).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
Related trials for Hypohidrotic Ectodermal Dysplasia
RecruitingPhase 2
Intraamniotic Administrations of ER004 to Male Subjects With X-linked Hypohidrotic Ectodermal Dysplasia
X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED)
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.
Holm Schneider, MD principal investigator
University Hospital Erlangen
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 Hypohidrotic Ectodermal Dysplasia, run by University Hospital Erlangen at 1 site in Germany.
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: finished, as of the sponsor's last update on 16 Aug 2021. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
age-dependence of SARS-CoV-2 infection (time frame: 3 months from the point in time at which the first household member shows symptoms of COVID-19). The study lists 6 primary outcomes in all. 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 16 Aug 2021.