Covid19NCT04487119
Hematology and Clinical Picture in Pediatric COVID-19 Infection
An observational study of Covid19, run by Benha University at 1 site in Egypt.
Trial summary
This study is to discuss the different clinical presentations, hematological and laboratory abnormalities in pediatric COVID-19 infection. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Covid19
- How many people
- 29 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Aug 2020to 23 Aug 2020
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- -inpatient confirmed COVID-19 infection by PCR
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pediatric COVID-19 Infection; Do Clinical Features and Hematological Parameters Predict the Need for ICU Admission?
This study is to discuss the different clinical presentations, hematological and laboratory abnormalities in pediatric COVID-19 infection.
Read the detailed description
This retrospective observational study will be conducted at Benha University Hospital, Benha, Egypt; after approval by the local ethical committee of Faculty of Medicine, Benha University, Egypt.
We will include in this retrospective study 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.
All data including demography information, contact history, previous history, clinical symptoms, clinical examination on admission, and hematology and laboratory information will be obtained from inpatient medical records.
- Conditions
- Covid19
- Keywords
- COVID19, hematology, pediatric
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
hematological findings
hematological indices; TLC, absolute lymphocytic count, absolute neutrophil count platelet count, N/L ratio and CRP in pediatric COVID-19 infection
Measured: at time of admission
Secondary outcomes (1)
clinical presentations
proportion of patients with respiratory and GIT symptoms, proportion of patients needs ICU admission relation between severity and hematologic indices
Measured: at time of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start12 Aug 2020
- Primary completion20 Aug 2020
- Study completion23 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Benha 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
- Retrospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Reda Abdelmaksoud, Benha University
- Investigators
- Shaimaa R Abdelmaksoud, MD, Principal investigator, Benha UniversityRana A Khashaba, MD, Study chair, Benha UniversityEffat H Assar, MD, Study chair, Benha UniversityRasha S Eldesouky, MD, Study chair, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487119
- Sponsor's protocol ID
- RC 6-7-2020
- Status last verified
- Sep 2020
- First submitted
- 24 Jul 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32031570Fan 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.
PubMed 32129508
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric COVID-19 Infection; Do Clinical Features and Hematological Parameters Predict the Need for ICU Admission?
- ClinicalTrials.gov ID
- NCT04487119
- Acronym / sponsor ID
- RC 6-7-2020
- Conditions
- Covid19
- Keywords
- COVID19, hematology, pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 23 Aug 2020 (actual)
- First posted
- 27 Jul 2020 (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.
This study is to discuss the different clinical presentations, hematological and laboratory abnormalities in pediatric COVID-19 infection.
Detailed description
This retrospective observational study will be conducted at Benha University Hospital, Benha, Egypt; after approval by the local ethical committee of Faculty of Medicine, Benha University, Egypt.
We will include in this retrospective study 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.
All data including demography information, contact history, previous history, clinical symptoms, clinical examination on admission, and hematology and laboratory information will be obtained from inpatient medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- -inpatient confirmed COVID-19 infection by PCR
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hematological findings
Time frame: at time of admission
hematological indices; TLC, absolute lymphocytic count, absolute neutrophil count platelet count, N/L ratio and CRP in pediatric COVID-19 infection
1 secondary outcome
clinical presentations
Time frame: at time of admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Background: PubMed 32031570Wang 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.
- Background: PubMed 32129508Fan 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.
- Individual participant dataSharing planned: No
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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.
Shaimaa R Abdelmaksoud, MD principal investigator
Benha University
Rana A Khashaba, MD study chair
Benha University
Effat H Assar, MD study chair
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Benha University at 1 site in Egypt.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hematological findings (time frame: at time of admission). 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 NCT04487119, which also lists 2 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 9 Sep 2020.