Post COVID-19 ConditionNCT05745974
Post COVID-19 Complications in Children
An observational study of Post COVID-19 Condition, run by Assiut University.
Trial summary
Is to record post COVID-19 complications in patients below 18 years old in assiut University children hospital Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Post COVID-19 Condition
- What is being tested?
- lymphocytic count
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 24 Feb 2023to Mar 2023
- 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 1 month to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: children below 18 years of age
Who may be able to join
- 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
Who cannot join
- Patients above 18 years
- Patients having psychological disorders patients having chronic disease like cardiac, chest , and renal diseases
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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.
- Conditions
- Post COVID-19 Condition
- Being tested
- lymphocytic count
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymphocytic countDiagnostic test
Also called C-Reactive Protein, serum ferritin, D dimer, RT PCR for COVID-19
taking blood samples and COVID-19 swab
What is being measured
The primary outcome is the main question the study is designed to answer.
record post COVID-19 complications in patients below 18 years old
detection of any complications related to post infection with COVID-19 by using the laboratory investigations
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start24 Feb 2023 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Post COVID-19 ConditionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehad Gamal Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745974
- Sponsor's protocol ID
- Post COVID-19 complications
- Status last verified
- Feb 2023
- First submitted
- 23 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33895804AbdelMassih 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.
PubMed 32803145Han 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.
PubMed 32857112DeBiasi 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.
PubMed 32857158Butler 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.
PubMed 33051183Baker 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.
PubMed 33187638McMurray 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.
PubMed 33425823Riphagen 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.
PubMed 32386565Jones 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.
PubMed 32265235Mitchell 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.
PubMed 33661561
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post COVID-19 Complications in Children Attending Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT05745974
- Acronym / sponsor ID
- Post COVID-19 complications
- Conditions
- Post COVID-19 Condition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 24 Feb 2023 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 27 Feb 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- children below 18 years of age
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients above 18 years
- Patients having psychological disorders patients having chronic disease like cardiac, chest , and renal diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lymphocytic countAlso: C-Reactive Protein, serum ferritin, D dimer, RT PCR for COVID-19taking blood samples and COVID-19 swab | Diagnostic test | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Background: PubMed 33895804Whitworth 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.
- Results publication: PubMed 32803145AbdelMassih 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.
- Results publication: PubMed 32857112Han 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.
- Results publication: PubMed 32857158DeBiasi 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.
- Results publication: PubMed 33051183Butler 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.
- Results publication: PubMed 33187638Baker 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.
- Results publication: PubMed 33425823McMurray 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.
- Results publication: PubMed 32386565Riphagen 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.
- Results publication: PubMed 32265235Jones 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.
- Results publication: PubMed 33661561Mitchell 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.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Post COVID-19 Condition, run by Assiut University.
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 4 inclusion and 2 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 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Gehad Gamal Ali, MD (01016957283, jeejeeali2023@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
record post COVID-19 complications in patients below 18 years old (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05745974, which also lists 10 linked publications.
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 28 Feb 2023.