Long COVIDNCT05799508
Consequences of COVID-19 Infection for Child Health and Wellbeing: Protocol for a Prospective, Observational, Longitudinal Study in Children
An observational study of Long COVID, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Prospective follow-up of children with SARS-CoV-2 Read more about this study
- Who is it for?
- Ages 4 weeks to 18 years
- Conditions the study is for
- Long COVID
- How many people
- 1,200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 31 Dec 2024
- 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 4 weeks to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population will consist of patients diagnosed with COVID-19 and admitted to the hospitals and/or assessed in primary care among our Institution. Patients will be identified from existing local cohorts. Inclusion criteria: * Children aged 0-18 years * The child sought/needed primary or secondary medical care for COVID-19 * Laboratory (RT-PCR,) [18] * 28 days - 3 months from the onset of COVID-19 symptoms * Parent's/carer's/guardian's consent to participate The survey for paediatric follow-up is based on the previously developed adult questionnaire. The survey has been adapted to specific age groups to identify specific symptoms in children.
Who may be able to join
- Children aged 0-18 years
- The child sought/needed primary or secondary medical care for COVID-19
- Laboratory (RT-PCR,) [18]
- 28 days - 3 months from the onset of COVID-19 symptoms
- Parent's/carer's/guardian's consent to participate
Who cannot join
- adults
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Gemelli
Roma
danilo buonsenso, md, 3319819715, danilobuonsenso@gmail.com
About this study
Prospective follow-up of children with SARS-CoV-2
- Conditions
- Long COVID
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
number of children developing long covid
prevalence of post covid condition at 3-6-12-18-24-36 months after SARS-CoV-3 infection
Measured: up to 36 months
Secondary outcomes (1)
duration and characteristics of children with long covid, also according to variants
prevalence of post covid condition according to the original SARS-CoV-2 variant at 3-6-12-18-24-36 months after SARS-CoV-3 infection
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Jan 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- 1,200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799508
- Sponsor's protocol ID
- ID 3777
- Status last verified
- Feb 2023
- First submitted
- 29 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: to contact the PI, sharing planned with GBD
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of COVID-19 Infection for Child Health and Wellbeing: Protocol for a Prospective, Observational, Longitudinal Study in Children
- ClinicalTrials.gov ID
- NCT05799508
- Acronym / sponsor ID
- ID 3777
- Conditions
- Long COVID
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Apr 2023 (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.
Prospective follow-up of children with SARS-CoV-2
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population will consist of patients diagnosed with COVID-19 and admitted to the hospitals and/or assessed in primary care among our Institution. Patients will be identified from existing local cohorts. Inclusion criteria: * Children aged 0-18 years * The child sought/needed primary or secondary medical care for COVID-19 * Laboratory (RT-PCR,) [18] * 28 days - 3 months from the onset of COVID-19 symptoms * Parent's/carer's/guardian's consent to participate The survey for paediatric follow-up is based on the previously developed adult questionnaire. The survey has been adapted to specific age groups to identify specific symptoms in children.
Key inclusion criteria (5 listed)
- Children aged 0-18 years
- The child sought/needed primary or secondary medical care for COVID-19
- Laboratory (RT-PCR,) [18]
- 28 days - 3 months from the onset of COVID-19 symptoms
- Parent's/carer's/guardian's consent to participate
Key exclusion criteria (1 listed)
- adults
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
number of children developing long covid
Time frame: up to 36 months
prevalence of post covid condition at 3-6-12-18-24-36 months after SARS-CoV-3 infection
1 secondary outcome
duration and characteristics of children with long covid, also according to variants
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Individual participant dataSharing planned: Yes. to contact the PI, sharing planned with GBD
Related trials for Long COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
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.
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 Long COVID, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Apr 2023. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of children developing long covid (time frame: up to 36 months). 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 5 Apr 2023.