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

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.

Study Overview

• Status: Completed
• Conditions: Coronavirus COVID-19

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 800

Contacts and Locations

• Study Contact: Name: Fatma Ebeid; Phone Number: +201095569596; Email: dr.fatma_ebeid@yahoo.com

Study Locations

• Egypt
  • Non-US
    • Cairo, Non-US, Egypt, 11566
      • Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of COVID-19 among children with cancer	Measure the incidence of COVID-19 infection among children with cancer	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Families training	Families training about adhering to standard precautions for basic and respiratory hygiene to reduce the risk of transmission	12 months

Collaborators and Investigators

• Sponsor: Fatma Soliman Elsayed Ebeid, MD
• Investigators: Principal Investigator: Fatma Ebeid, Excuitive Director of MARSI-CRC

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: May 25, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: FMASU P25a/ 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No