Coronavirus COVID-19PedCan-COVIDNCT04404244
Extraordinary Measures for Egyptian Children With Hemato-Oncological Disorders During COVID-19 Pandemic
An observational study of Coronavirus COVID-19, run by Fatma Soliman Elsayed Ebeid, MD at 1 site in Egypt.
Trial summary
This is a prospective follow-up non-intervention study that will be carried out at Hematology/ Oncology Department, Children's hospital, Ain-Shams University, Cairo, Egypt. All followed-up children below 18 years with cancer during the one year study period from May 2020 till Apr 2021 either at the out-patients clinic… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Coronavirus COVID-19
- How many people
- 800 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 Jan 2024
- 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 followed-up children below 18 years with with malignancy either hematological or solid tumors or hematological condition during the one year study period from May 2020 till Apr 2021 either at the out-patients clinic or inpatient department will be recruited.
Who may be able to join
- Children below 18 years with malignancy either hematological or solid tumors or
- Children below 18 years with hematological condition
Who cannot join
- 1. Patients or care-givers refusal to be enrolled in the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, 11566
About this study
This is a prospective follow-up non-intervention study that will be carried out at Hematology/ Oncology Department, Children's hospital, Ain-Shams University, Cairo, Egypt. All followed-up children below 18 years with cancer during the one year study period from May 2020 till Apr 2021 either at the out-patients clinic or inpatient department will be recruited.
Read the detailed description
Study Procedures:
On admission or during the outpatient visit:
- Obtaining an informed consent .
- Full medical history, concurrent medications, demographic data and epidemiological data (history of contact to a COVID-19 case, history of travel), will be obtained.
- A thorough physical examination will be performed.
- Body weight, height, BMI, vital signs (blood pressure, heart rate and temperature) and blood oxygen saturation) will be recorded.
- Laboratory to perform the following tests:
Complete blood count with differential counts, COVID -19 reverse Transcription Polymerase Chain Reaction (RT-PCR) test by nasopharyngeal swab.
During admission:
Whenever unexplained fever and or respiratory symptoms developed or whenever COVID19 suspected to have the following to be performed:
- Symptom developed that necessitates to repeat oropharyngeal and nasopharyngeal swab if indicated will be collected
- Chest X-ray or CT chest will be recorded.
- Laboratory to perform the following tests:
Complete blood count with differential counts,
COVID-19 RT-PCR test by oropharyngeal and nasopharyngeal swab:
C-reactive protein and serum ferritin level. Coagulation test; D. dimer, prothrombin time and INR. Routine bacteriological study, blood culture and other symptoms/signs based cultures will be recorded
On discharge:
- Date of discharge
- Period of admission
- Period of fever
- A thorough physical examination will be performed
- Record the outcome
- Conditions
- Coronavirus COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of COVID-19 among children with cancer
Measure the incidence of COVID-19 infection among children with cancer
Measured: 12 months
Secondary outcomes (1)
Families training
Families training about adhering to standard precautions for basic and respiratory hygiene to reduce the risk of transmission
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Jan 2020
- Primary completion1 Nov 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus COVID-19Studies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatma Soliman Elsayed Ebeid, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fatma Soliman Elsayed Ebeid, MD, Ain Shams University
- Investigators
- Fatma Ebeid, Principal investigator, Excuitive Director of MARSI-CRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404244
- Sponsor's protocol ID
- FMASU P25a/ 2020
- Acronym
- PedCan-COVID
- Status last verified
- Jan 2024
- First submitted
- 25 May 2020
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ebeid FSE, Ragab IA, Elsherif NHK, Makkeyah S, Mostafa S, Eltonbary K, Matbouly S, Mostafa A, Goma H, Agwa SH, Hafez HM, Girgis S, El Gendy YG, El-Sayed MH. COVID-19 in Children With Cancer: A Single Low-Middle Income Center Experience. J Pediatr Hematol Oncol. 2021 Nov 1;43(8):e1077-e1081. doi: 10.1097/MPH.0000000000002025.
PubMed 33290293
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extraordinary Measures for Egyptian Children With Hemato-Oncological Disorders During COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04404244
- Acronym / sponsor ID
- PedCan-COVID / FMASU P25a/ 2020
- Conditions
- Coronavirus COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Fatma Soliman Elsayed Ebeid, MDUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 27 May 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 is a prospective follow-up non-intervention study that will be carried out at Hematology/ Oncology Department, Children's hospital, Ain-Shams University, Cairo, Egypt. All followed-up children below 18 years with cancer during the one year study period from May 2020 till Apr 2021 either at the out-patients clinic or inpatient department will be recruited.
Detailed description
Study Procedures:
On admission or during the outpatient visit:
- Obtaining an informed consent .
- Full medical history, concurrent medications, demographic data and epidemiological data (history of contact to a COVID-19 case, history of travel), will be obtained.
- A thorough physical examination will be performed.
- Body weight, height, BMI, vital signs (blood pressure, heart rate and temperature) and blood oxygen saturation) will be recorded.
- Laboratory to perform the following tests:
Complete blood count with differential counts, COVID -19 reverse Transcription Polymerase Chain Reaction (RT-PCR) test by nasopharyngeal swab.
During admission:
Whenever unexplained fever and or respiratory symptoms developed or whenever COVID19 suspected to have the following to be performed:
- Symptom developed that necessitates to repeat oropharyngeal and nasopharyngeal swab if indicated will be collected
- Chest X-ray or CT chest will be recorded.
- Laboratory to perform the following tests:
Complete blood count with differential counts,
COVID-19 RT-PCR test by oropharyngeal and nasopharyngeal swab:
C-reactive protein and serum ferritin level. Coagulation test; D. dimer, prothrombin time and INR. Routine bacteriological study, blood culture and other symptoms/signs based cultures will be recorded
On discharge:
- Date of discharge
- Period of admission
- Period of fever
- A thorough physical examination will be performed
- Record the outcome
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All followed-up children below 18 years with with malignancy either hematological or solid tumors or hematological condition during the one year study period from May 2020 till Apr 2021 either at the out-patients clinic or inpatient department will be recruited.
Key inclusion criteria (2 listed)
- Children below 18 years with malignancy either hematological or solid tumors or
- Children below 18 years with hematological condition
Key exclusion criteria (1 listed)
- 1. Patients or care-givers refusal to be enrolled in 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
Incidence of COVID-19 among children with cancer
Time frame: 12 months
Measure the incidence of COVID-19 infection among children with cancer
1 secondary outcome
Families training
Time frame: 12 months
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 12 Jan 2024.
- Results publication: PubMed 33290293Ebeid FSE, Ragab IA, Elsherif NHK, Makkeyah S, Mostafa S, Eltonbary K, Matbouly S, Mostafa A, Goma H, Agwa SH, Hafez HM, Girgis S, El Gendy YG, El-Sayed MH. COVID-19 in Children With Cancer: A Single Low-Middle Income Center Experience. J Pediatr Hematol Oncol. 2021 Nov 1;43(8):e1077-e1081. doi: 10.1097/MPH.0000000000002025.
- 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.
Fatma Ebeid principal investigator
Excuitive Director of MARSI-CRC
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 Coronavirus COVID-19, run by Fatma Soliman Elsayed Ebeid, MD 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 2 inclusion and 1 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 12 Jan 2024. 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?
Incidence of COVID-19 among children with cancer (time frame: 12 months). 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 NCT04404244, which also lists 1 linked publication.
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 12 Jan 2024.