Extraordinary Measures for Egyptian Children With Hemato-Oncological Disorders During COVID-19 Pandemic

Coronavirus COVID-19 Clinical Trial

— PedCan-COVID  

Official title:

Extraordinary Measures for Egyptian Children With Hemato-Oncological Disorders During COVID-19 Pandemic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04404244
• Other study ID #: FMASU P25a/ 2020
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: January 1, 2024

Study information

• Verified date: January 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 or inpatient department will be recruited.

Description:

Study Procedures:

On admission or during the outpatient visit:

1. Obtaining an informed consent .

2. Full medical history, concurrent medications, demographic data and epidemiological data (history of contact to a COVID-19 case, history of travel), will be obtained.

3. A thorough physical examination will be performed.

4. Body weight, height, BMI, vital signs (blood pressure, heart rate and temperature) and blood oxygen saturation) will be recorded.

5. 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:

1. Symptom developed that necessitates to repeat oropharyngeal and nasopharyngeal swab if indicated will be collected

2. Chest X-ray or CT chest will be recorded.

3. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: January 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

1. Children below 18 years with malignancy either hematological or solid tumors or

2. Children below 18 years with hematological condition

Exclusion Criteria:

1. Patients or care-givers refusal to be enrolled in the study

Related Conditions & MeSH terms

• Coronavirus COVID-19
• COVID-19

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center	Cairo	Non-US

Sponsors (1)

Lead Sponsor	Collaborator
Fatma Soliman Elsayed Ebeid, MD

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of COVID-19 among children with cancer	Measure the incidence of COVID-19 infection among children with cancer	12 months
Secondary	Families training	Families training about adhering to standard precautions for basic and respiratory hygiene to reduce the risk of transmission	12 months