Clinical trial NCT05745974: Post COVID-19 Complications in Children
Official title: Post COVID-19 Complications in Children Attending Assiut University Children Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post COVID-19 Condition
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children below 18 years of age

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: record post COVID-19 complications in patients below 18 years old
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.