Persistent SARS-CoV-2 Infection in Children With Cancer and Impaired Immune Responsiveness

Sponsor

Children's Cancer Hospital Egypt 57357 (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05172063

Collaborator

National Research Centre, Egypt (Other), Pfizer (Industry)

Enrollment

Location

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main goal of this study is to characterize the adaptive immune responses to SARS-CoV-2 infection in a cohort of children with cancer and impaired immune responsiveness and prolonged viral shedding of SARS-CoV-2, and to identify SARS-CoV-2 variants that might arise during poorly controlled virus replication

Condition or Disease	Intervention/Treatment	Phase
Children With Cancer SARS-CoV-2 Infection

Detailed Description

Although the adaptive immune response plays an important role in improving clinical outcomes of patients infected with SARS2, variability in clinical disease and outcome in patients with SARS2 infection has not been explained by the variation in qualitative and quantitative antiviral immune responses. It has been observed that immunocompromised children shed the virus from the upper respiratory tract for prolonged periods of time, even after the resolution of clinical symptoms. Thus deficits in adaptive immune responses might lead to ineffective control of virus replication and prolonged virus shedding. The proposed studies will define the relationship between adaptive immunity and virus replication/shedding, including the contribution of viral variants that could arise during poorly controlled virus replication in children with ineffective immune responses. The specific aims of the proposed study are: (a) To measure (quantify and qualify) the adaptive immune responses (humoral and cell-mediated immune responses) after infection with SARS-CoV-2 in a cohort of hospitalized children with cancer and impaired immune response. (b) To define the long-term kinetics of the antibody response, cell-mediated immune responses following infection with SARS-CoV-2 in a cohort of hospitalized children with cancer and impaired immune response, and to estimate the duration of protective immunity.(c) to statistically assess whether impaired humoral immunity is associated with prolonged viral replication and shedding (persistence) following infection with SARS-CoV-2 in a cohort of children with cancer and impaired immune response, (d) To genetically trace SARS-CoV-2 mutations, and statistically assess the association between persistent SARS-CoV-2 infection and the frequency of viral mutations and the emergence of viral variants in a cohort of children with cancer and impaired immune response, after their infection with SARS-CoV-2 This will be a prospective, observational cohort study design. The study population will include pediatric and adolescent patients undergoing cancer chemotherapy with a confirmed SARS-CoV-2 infection (PCR Positive). Eligible subjects will be followed prospectively for three months from the time they tested positive for SARS-CoV-2 by PCR. SARS-CoV-2 RNA, antibody, and cell-mediated immune responses will be assessed at specified time points and compared between the children with persistent SARS-CoV-2 infection, and those who cleared SARS-CoV-2 virus. Sequence viral variants in the persistent SARS-COV-2 infected group Assess the association between the emergence of viral variants and mutations and strain virulence and clinical outcome

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Persistent SARS-CoV-2 Infection in Children With Cancer and Impaired Immune Responsiveness

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Persistent SARS-CoV-2 Infection Group Pediatric Cancer patients with persistent SARS-CoV-2 infection
SARS-CoV-2 Clearance Group Pediatric Cancer patients who tested negative for SARS-CoV-2 within 14 days of diagnosis.

Outcome Measures

Primary Outcome Measures

SARS-CoV-2 antibody titers [Three months]
Different subsets of immune cells (neutrophils, dendritic cells, B- and T- lymphocytes) [Three months]

Secondary Outcome Measures

Sequence viral variants in the persistent SARS-COV-2 infected group [Three months]
Assess the association between the emergence of viral variants and mutations and strain virulence and clinical outcome [Three months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children (<18) of both genders undergoing cancer chemotherapy
Symptomatic SARS-CoV-2 infection, confirmed by (positive PCR test).
Patients with hematologic malignancies (ALL, AML, HL & NHL) on active treatment or under follow up < 3 months from end of treatment protocol

Exclusion Criteria:

Children (<18 years) of both genders undergoing cancer chemotherapy with (PCR negative) test result for SARS-CoV-2.
Children who are PCR positive but are diagnosed with an immune disorder that may confound the study results.