Post COVID-19 Complications in Children

NCT ID: NCT05745974

Last Updated: 2023-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-24

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post COVID-19 Condition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

lymphocytic count

taking blood samples and COVID-19 swab

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

C-Reactive Protein serum ferritin D dimer RT PCR for COVID-19

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gehad Gamal Ali

physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gehad Gamal Ali, MD

Role: CONTACT

Phone: 01016957283

Email: [email protected]

Azza ahmed Al-Tayeb, Professor

Role: CONTACT

Phone: 01006863277

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 33895804 (View on PubMed)

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.

Reference Type RESULT
PMID: 32803145 (View on PubMed)

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.

Reference Type RESULT
PMID: 32857112 (View on PubMed)

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.

Reference Type RESULT
PMID: 32857158 (View on PubMed)

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.

Reference Type RESULT
PMID: 33051183 (View on PubMed)

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.

Reference Type RESULT
PMID: 33187638 (View on PubMed)

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.

Reference Type RESULT
PMID: 33425823 (View on PubMed)

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.

Reference Type RESULT
PMID: 32386565 (View on PubMed)

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.

Reference Type RESULT
PMID: 32265235 (View on PubMed)

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.

Reference Type RESULT
PMID: 33661561 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Post COVID-19 complications

Identifier Type: -

Identifier Source: org_study_id