Clinical trial NCT04404244: Extraordinary Measures for Egyptian Children With Hemato-Oncological Disorders During COVID-19 Pandemic
Official title: Extraordinary Measures for Egyptian Children With Hemato-Oncological Disorders During COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus COVID-19
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 800
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of COVID-19 among children with cancer
timeFrame: 12 months
Secondary outcomes:
measure: Families training
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
state: Non-US
Study officials:
affiliation: Excuitive Director of MARSI-CRC
name: Fatma Ebeid
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.