NCT04487119

Brief Summary

This study is to discuss the different clinical presentations, hematological and laboratory abnormalities in pediatric COVID-19 infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

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

July 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

August 12, 2020

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2020

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

8 days

First QC Date

July 24, 2020

Last Update Submit

September 6, 2020

Conditions

Keywords

COVID19hematologypediatric

Outcome Measures

Primary Outcomes (1)

  • hematological findings

    hematological indices; TLC, absolute lymphocytic count, absolute neutrophil count platelet count, N/L ratio and CRP in pediatric COVID-19 infection

    at time of admission

Secondary Outcomes (1)

  • clinical presentations

    at time of admission

Eligibility Criteria

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

all pediatric patients who were admitted with confirmed COVID-19 infection with age range from birth to 18 years during the period from April 2020 till July 2020. The diagnosis of COVID-19 infection is based on positive SARS-CoV-2 RNA detection in throat swab specimens by PCR.

You may qualify if:

  • inpatient confirmed COVID-19 infection by PCR

You may not qualify if:

  • patients with records missing hematology and/or laboratory data,
  • patients transfered to other medical facilities with unknown outcomes,
  • patients with age older than 18 years from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha Faculty of Medicine

Banhā, Qalyubia Governorate, Egypt

Location

Related Publications (2)

  • Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

    PMID: 32031570BACKGROUND
  • Fan BE, Chong VCL, Chan SSW, Lim GH, Lim KGE, Tan GB, Mucheli SS, Kuperan P, Ong KH. Hematologic parameters in patients with COVID-19 infection. Am J Hematol. 2020 Jun;95(6):E131-E134. doi: 10.1002/ajh.25774. Epub 2020 Mar 19. No abstract available.

    PMID: 32129508BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Shaimaa R Abdelmaksoud, MD

    Benha University

    PRINCIPAL INVESTIGATOR
  • Rana A Khashaba, MD

    Benha University

    STUDY CHAIR
  • Effat H Assar, MD

    Benha University

    STUDY CHAIR
  • Rasha S Eldesouky, MD

    Benha University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Lecturer pediatrics

Study Record Dates

First Submitted

July 24, 2020

First Posted

July 27, 2020

Study Start

August 12, 2020

Primary Completion

August 20, 2020

Study Completion

August 23, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations