NCT05421247

Brief Summary

The aim of study is to: 1-describe demographic and clinical data of children infected with COVID-19 admitted at isolation unit of Assiut university children hospital 2- assess the risk factors responsible for complications of COVID-19 in children 3-assess the outcome of COVID-19 in children admitted at AUCH.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

1.2 years

First QC Date

June 15, 2022

Last Update Submit

August 8, 2022

Conditions

Keywords

childrenCOVID-19

Outcome Measures

Primary Outcomes (1)

  • to describe demographic and clinical data of children infected with COVID-19 admitted at isolation unit of Assiut university children hospital

    to describe demographic data (age ,sex ,residence , socioeconomics,...etc.) and length of hospital stay

    Baseline

Secondary Outcomes (2)

  • to assess the risk factors responsible for complications of COVID-19 in children.

    Baseline

  • to assess the outcome of COVID-19 in children admitted at AUCH

    Baseline

Eligibility Criteria

AgeUp to 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All children (up to 18 years) diagnosed with COVID-19 admitted at Isolaton Unit of Assiut university children hospital through the period from 1st January 2021 to 31st December 2022

You may qualify if:

  • All children (up to 18 years) diagnosed with COVID-19 admitted at Isolaton Unit of Assiut university children hospital through the period from 1st January 2021 to 31st December 2022

You may not qualify if:

  • Clinically suspected patients approved by CT chest and PCR not infected with COVID-19.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.

    PMID: 31995857BACKGROUND
  • Dong Y, Mo X, Hu Y, Qi X, Jiang F, Jiang Z, Tong S. Epidemiology of COVID-19 Among Children in China. Pediatrics. 2020 Jun;145(6):e20200702. doi: 10.1542/peds.2020-0702. Epub 2020 Mar 16.

    PMID: 32179660BACKGROUND
  • Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

    PMID: 32091533BACKGROUND
  • Livingston E, Bucher K. Coronavirus Disease 2019 (COVID-19) in Italy. JAMA. 2020 Apr 14;323(14):1335. doi: 10.1001/jama.2020.4344. No abstract available.

    PMID: 32181795BACKGROUND
  • CDC COVID-19 Response Team. Coronavirus Disease 2019 in Children - United States, February 12-April 2, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 10;69(14):422-426. doi: 10.15585/mmwr.mm6914e4.

    PMID: 32271728BACKGROUND
  • [6] Masoud H, Elassal G, Zaky S, Baki A, Ibrahim H, Amin W, et al. Management Protocol for COVID-19 Patients Version 1.4/30th May 2020 Ministry of health and population (MOHP), Egypt. 2020.

    BACKGROUND
  • [7] Mostafa A, Abdalbaky A, Fouda E, Shaaban H, Elnady H, Hassab-Allah M et al. Practical approach to COVID-19: an Egyptian pediatric consensus. Egyptian Pediatric Association Gazette. 2020;68(1).

    BACKGROUND
  • Klein JD, Koletzko B, El-Shabrawi MH, Hadjipanayis A, Thacker N, Bhutta Z. Promoting and supporting children's health and healthcare during COVID-19 - International Paediatric Association Position Statement. Arch Dis Child. 2020 Jul;105(7):620-624. doi: 10.1136/archdischild-2020-319370. Epub 2020 May 7. No abstract available.

    PMID: 32381517BACKGROUND
  • Chen ZM, Fu JF, Shu Q, Chen YH, Hua CZ, Li FB, Lin R, Tang LF, Wang TL, Wang W, Wang YS, Xu WZ, Yang ZH, Ye S, Yuan TM, Zhang CM, Zhang YY. Diagnosis and treatment recommendations for pediatric respiratory infection caused by the 2019 novel coronavirus. World J Pediatr. 2020 Jun;16(3):240-246. doi: 10.1007/s12519-020-00345-5. Epub 2020 Feb 5.

    PMID: 32026148BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nagla H. Ibrahim, professor

    STUDY DIRECTOR

Central Study Contacts

Yasser M. Abd Elaal

CONTACT

Mohamed A. Sayed, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident at Assiut University Children Hospital

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 16, 2022

Study Start

September 1, 2022

Primary Completion

December 1, 2023

Study Completion

June 1, 2024

Last Updated

August 9, 2022

Record last verified: 2022-08