Post COVID-19 Complications in Children

February 24, 2023 updated by: Gehad Gamal Ali, Assiut University

Post COVID-19 Complications in Children Attending Assiut University Children Hospital

Is to record post COVID-19 complications in patients below 18 years old in assiut University children hospital

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Coronavirus disease 2019 (COVID-19) is one of the largest public health pandemics since the Spanish flu of1918. With a wide spectrum of clinical manifestations, COVID-19 has caused major setbacks in healthcare worldwide and challenged the capabilities of some of the most accomplished health care systems in the world. Although up to 80% of patients are initially asymptomatic, a nonnegligible percentage eventually require hospitalization and intensive care admission (ICU)Johns Hopkins,2020.Currently, the worst complication of COVID-19 is vascular inflammation and degeneration, AbdelMassih AF, Kamel A et al. Most children with COVID-19 present with a range of signs and symptoms that are not severe or specific enough to prompt disease testing.3 Some children and adolescents show no symptoms at all,Han MS, Choi EH, et al .The challenge with unrecognized COVID-19 cases is that asymptomatic children might become silent carriers in the community, DeBiasi RL, Delaney M,et al.or be at risk of developing post-COVID-19 complications. post-acute COVID-19 includes patients with persistent or delayed symptoms that develop, or last, more than 3 weeks after symptom-onset. The 3-week period is in line with evidence that viable virus is rarely detected past 10 days in mild to moderate COVID-19, and rarely past 20 days in severe cases, DeBiasi RL, Delaney M, et al. Another term used to describe this condition is "long COVID". Butler M, Pollak TA, Baker HA,et al. Since MIS-C is not true sequelae, we will report on MIS-C separately from post-acute COVID-19. MIS-C is a newl recognized illness associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. McMurray et al. (2020) described MIS-C as a post-viral systemic inflammatory vasculopathy of children following SARS-CoV-2 infection, with similar clinical presentations to Kawasaki disease. Ontario Agency for Health Protection and Promotion,2020. In April 2020, reports from the United Kingdom documented a clinical presentation in children identical to Kawasaki disease (KD) or toxic shock syndrome. Since then, there has been an increase in reported cases of similarly affected children in other parts of the wothe, Riphagen S, Gomez X, et al ,2020. The cases have been reported from Asia, North America, Latin America and Europe in the past 3 months, describing children with COVID-19-associated multisystem inflammatory syndrome in children (MIS-C), which is likely to develop after the disease instead of developing during the acute phase of COVID-19 Jones VG, Mills M, et al, 2020.Thrombotic complications have alsobeen reported in children with COVID-19, Mitchell W, Davilla J, Whitworth H, Sartain SE,2020.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

children below 18 years of age

Description

Inclusion Criteria:

  • Patients below 18 years of age
  • Patients who are Tested swab positive for COVID-19
  • New cases that will be tested swab positive for COVID-19
  • Pateints who are suspected of kawazaki disease

Exclusion Criteria:

  • Patients above 18 years
  • Patients having psychological disorders patients having chronic disease like cardiac, chest , and renal diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
record post COVID-19 complications in patients below 18 years old
Time Frame: Baseline
detection of any complications related to post infection with COVID-19 by using the laboratory investigations
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Post COVID-19 complications

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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