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

December 26, 2021 updated by: Children's Cancer Hospital Egypt 57357
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

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Children's Cancer Hospital Egypt 57357 Cairo, Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will include pediatric and adolescent patients undergoing cancer chemotherapy with a confirmed SARS-CoV-2 infection (PCR Positive). We will recruit 30 patients undergoing cancer chemotherapy with a confirmed SARS-CoV-2 infection (PCR Positive). Twenty children with persistent SARS-CoV-2 infection, and 10 children with SARS-CoV-2 clearance within 14 days of diagnosis

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SARS-CoV-2 antibody titers
Time Frame: Three months
Three months
Different subsets of immune cells (neutrophils, dendritic cells, B- and T- lymphocytes)
Time Frame: Three months
Three months

Secondary Outcome Measures

Outcome Measure
Time Frame
Sequence viral variants in the persistent SARS-COV-2 infected group
Time Frame: Three months
Three months
Assess the association between the emergence of viral variants and mutations and strain virulence and clinical outcome
Time Frame: Three months
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Cancer Hospital Egypt 57357

Collaborators

Pfizer
National Research Centre, Egypt

Investigators

  • Principal Investigator: Mohamed Diaaeldin Hashem, MBBCh, MSc, Children's Cancer Hospital Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

December 26, 2021

First Submitted That Met QC Criteria

December 26, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Actual)

December 29, 2021

Last Update Submitted That Met QC Criteria

December 26, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCHE-Persistent SARS-CoV-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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