- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05745974
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
Not yet recruiting
Conditions
Intervention / Treatment
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
Observational
Enrollment (Anticipated)
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
- Name: Gehad Gamal Ali, MD
- Phone Number: 01016957283
- Email: jeejeeali2023@gmail.com
Study Contact Backup
- Name: Azza ahmed Al-Tayeb, Professor
- Phone Number: 01006863277
- Email: azza.eisa@med.eu.eg
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
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
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
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
- Whitworth H, Sartain SE, Kumar R, Armstrong K, Ballester L, Betensky M, Cohen CT, Diaz R, Diorio C, Goldenberg NA, Jaffray J, Keegan J, Malone K, Randolph AG, Rifkin-Zenenberg S, Leung WS, Sochet A, Srivaths L, Zia A, Raffini L. Rate of thrombosis in children and adolescents hospitalized with COVID-19 or MIS-C. Blood. 2021 Jul 15;138(2):190-198. doi: 10.1182/blood.2020010218.
- AbdelMassih AF, Kamel A, Mishriky F, Ismail HA, El Qadi L, Malak L, El-Husseiny M, Ashraf M, Hafez N, AlShehry N, El-Husseiny N, AbdelRaouf N, Shebl N, Hafez N, Youssef N, Afdal P, Hozaien R, Menshawey R, Saeed R, Fouda R. Is it infection or rather vascular inflammation? Game-changer insights and recommendations from patterns of multi-organ involvement and affected subgroups in COVID-19. Cardiovasc Endocrinol Metab. 2020 Jun 11;9(3):110-120. doi: 10.1097/XCE.0000000000000211. eCollection 2020 Sep.
- Han MS, Choi EH, Chang SH, Jin BL, Lee EJ, Kim BN, Kim MK, Doo K, Seo JH, Kim YJ, Kim YJ, Park JY, Suh SB, Lee H, Cho EY, Kim DH, Kim JM, Kim HY, Park SE, Lee JK, Jo DS, Cho SM, Choi JH, Jo KJ, Choe YJ, Kim KH, Kim JH. Clinical Characteristics and Viral RNA Detection in Children With Coronavirus Disease 2019 in the Republic of Korea. JAMA Pediatr. 2021 Jan 1;175(1):73-80. doi: 10.1001/jamapediatrics.2020.3988.
- DeBiasi RL, Delaney M. Symptomatic and Asymptomatic Viral Shedding in Pediatric Patients Infected With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2): Under the Surface. JAMA Pediatr. 2021 Jan 1;175(1):16-18. doi: 10.1001/jamapediatrics.2020.3996. No abstract available.
- Butler M, Pollak TA, Rooney AG, Michael BD, Nicholson TR. Neuropsychiatric complications of covid-19. BMJ. 2020 Oct 13;371:m3871. doi: 10.1136/bmj.m3871. No abstract available.
- Baker HA, Safavynia SA, Evered LA. The 'third wave': impending cognitive and functional decline in COVID-19 survivors. Br J Anaesth. 2021 Jan;126(1):44-47. doi: 10.1016/j.bja.2020.09.045. Epub 2020 Oct 21. No abstract available.
- McMurray JC, May JW, Cunningham MW, Jones OY. Multisystem Inflammatory Syndrome in Children (MIS-C), a Post-viral Myocarditis and Systemic Vasculitis-A Critical Review of Its Pathogenesis and Treatment. Front Pediatr. 2020 Dec 16;8:626182. doi: 10.3389/fped.2020.626182. eCollection 2020.
- Riphagen S, Gomez X, Gonzalez-Martinez C, Wilkinson N, Theocharis P. Hyperinflammatory shock in children during COVID-19 pandemic. Lancet. 2020 May 23;395(10237):1607-1608. doi: 10.1016/S0140-6736(20)31094-1. Epub 2020 May 7. No abstract available.
- Jones VG, Mills M, Suarez D, Hogan CA, Yeh D, Segal JB, Nguyen EL, Barsh GR, Maskatia S, Mathew R. COVID-19 and Kawasaki Disease: Novel Virus and Novel Case. Hosp Pediatr. 2020 Jun;10(6):537-540. doi: 10.1542/hpeds.2020-0123. Epub 2020 Apr 7.
- Mitchell WB, Davila J, Keenan J, Jackson J, Tal A, Morrone KA, Silver EJ, O'Brien S, Manwani D. Children and young adults hospitalized for severe COVID-19 exhibit thrombotic coagulopathy. Pediatr Blood Cancer. 2021 Jul;68(7):e28975. doi: 10.1002/pbc.28975. Epub 2021 Mar 4.
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)
February 24, 2023
Primary Completion (Anticipated)
February 28, 2023
Study Completion (Anticipated)
March 1, 2023
Study Registration Dates
First Submitted
February 23, 2023
First Submitted That Met QC Criteria
February 23, 2023
First Posted (Actual)
February 27, 2023
Study Record Updates
Last Update Posted (Estimate)
February 28, 2023
Last Update Submitted That Met QC Criteria
February 24, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Molecular Mechanisms of Pharmacological Action
- Fibrin Modulating Agents
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Fibrin fragment D
Other Study ID 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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