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

NCT05172063 | Unknown

• 1 other identifier: CCHE-Persistent SARS-CoV-2
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Children With Cancer; SARS-CoV-2 Infection

Keywords

Children; Cancer; SARS-CoV-2; Adaptive Immune Response

Outcome Measures

Primary Outcomes (2)

• SARS-CoV-2 antibody titers

  Three months

• Different subsets of immune cells (neutrophils, dendritic cells, B- and T- lymphocytes)

  Three months

Secondary Outcomes (2)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Cancer Hospital Egypt 57357: lead
• National Research Centre, Egypt: collaborator
• Pfizer: collaborator

Study Sites (1)

Children's Cancer Hospital Egypt 57357 Cairo, Egypt

Cairo, Egypt

Location

Related Publications (10)

• Sethuraman N, Jeremiah SS, Ryo A. Interpreting Diagnostic Tests for SARS-CoV-2. JAMA. 2020 Jun 9;323(22):2249-2251. doi: 10.1001/jama.2020.8259. No abstract available.

  PMID: 32374370 RESULT

• Avanzato VA, Matson MJ, Seifert SN, Pryce R, Williamson BN, Anzick SL, Barbian K, Judson SD, Fischer ER, Martens C, Bowden TA, de Wit E, Riedo FX, Munster VJ. Case Study: Prolonged Infectious SARS-CoV-2 Shedding from an Asymptomatic Immunocompromised Individual with Cancer. Cell. 2020 Dec 23;183(7):1901-1912.e9. doi: 10.1016/j.cell.2020.10.049. Epub 2020 Nov 4.

  PMID: 33248470 RESULT

• Baang JH, Smith C, Mirabelli C, Valesano AL, Manthei DM, Bachman MA, Wobus CE, Adams M, Washer L, Martin ET, Lauring AS. Prolonged Severe Acute Respiratory Syndrome Coronavirus 2 Replication in an Immunocompromised Patient. J Infect Dis. 2021 Jan 4;223(1):23-27. doi: 10.1093/infdis/jiaa666.

  PMID: 33089317 RESULT

• Choi B, Choudhary MC, Regan J, Sparks JA, Padera RF, Qiu X, Solomon IH, Kuo HH, Boucau J, Bowman K, Adhikari UD, Winkler ML, Mueller AA, Hsu TY, Desjardins M, Baden LR, Chan BT, Walker BD, Lichterfeld M, Brigl M, Kwon DS, Kanjilal S, Richardson ET, Jonsson AH, Alter G, Barczak AK, Hanage WP, Yu XG, Gaiha GD, Seaman MS, Cernadas M, Li JZ. Persistence and Evolution of SARS-CoV-2 in an Immunocompromised Host. N Engl J Med. 2020 Dec 3;383(23):2291-2293. doi: 10.1056/NEJMc2031364. Epub 2020 Nov 11. No abstract available.

  PMID: 33176080 RESULT

• Aydillo T, Gonzalez-Reiche AS, Aslam S, van de Guchte A, Khan Z, Obla A, Dutta J, van Bakel H, Aberg J, Garcia-Sastre A, Shah G, Hohl T, Papanicolaou G, Perales MA, Sepkowitz K, Babady NE, Kamboj M. Shedding of Viable SARS-CoV-2 after Immunosuppressive Therapy for Cancer. N Engl J Med. 2020 Dec 24;383(26):2586-2588. doi: 10.1056/NEJMc2031670. Epub 2020 Dec 1. No abstract available.

  PMID: 33259154 RESULT

• Truong TT, Ryutov A, Pandey U, Yee R, Goldberg L, Bhojwani D, Aguayo-Hiraldo P, Pinsky BA, Pekosz A, Shen L, Boyd SD, Wirz OF, Roltgen K, Bootwalla M, Maglinte DT, Ostrow D, Ruble D, Han JH, Biegel JA, Li M, Huang C, Sahoo MK, Pannaraj PS, O'Gorman M, Judkins AR, Gai X, Dien Bard J. Increased viral variants in children and young adults with impaired humoral immunity and persistent SARS-CoV-2 infection: A consecutive case series. EBioMedicine. 2021 May;67:103355. doi: 10.1016/j.ebiom.2021.103355. Epub 2021 Apr 26.

  PMID: 33915337 RESULT

• Turner JS, Day A, Alsoussi WB, Liu Z, O'Halloran JA, Presti RM, Patterson BK, Whelan SPJ, Ellebedy AH, Mudd PA. SARS-CoV-2 Viral RNA Shedding for More Than 87 Days in an Individual With an Impaired CD8+ T Cell Response. Front Immunol. 2021 Jan 8;11:618402. doi: 10.3389/fimmu.2020.618402. eCollection 2020.

  PMID: 33488630 RESULT

• Gomaa MR, Kandeil A, Mostafa A, Roshdy WH, Kayed AE, Shehata M, Kutkat O, Moatasim Y, El Taweel A, Mahmoud SH, Kamel MN, Abo Shama NM, El Sayes M, El-Shesheny R, Bakheet OH, Elgohary MA, Elbadry M, Nassif NN, Ahmed SH, Abdel Messih IY, Kayali G, Ali MA. Prevalence of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Antibodies in Egyptian Convalescent Plasma Donors. Front Microbiol. 2020 Nov 24;11:596851. doi: 10.3389/fmicb.2020.596851. eCollection 2020.

  PMID: 33329484 RESULT

• Gomaa MR, El Rifay AS, Shehata M, Kandeil A, Nabil Kamel M, Marouf MA, GabAllah M, El Taweel A, Kayed AE, Kutkat O, Moatasim Y, Mahmoud SH, Abo Shama NM, El Sayes M, Mostafa A, El-Shesheny R, McKenzie PP, Webby RJ, Kayali G, Ali MA. Incidence, household transmission, and neutralizing antibody seroprevalence of Coronavirus Disease 2019 in Egypt: Results of a community-based cohort. PLoS Pathog. 2021 Mar 11;17(3):e1009413. doi: 10.1371/journal.ppat.1009413. eCollection 2021 Mar.

  PMID: 33705496 RESULT

• Schmidt F, Weisblum Y, Muecksch F, Hoffmann HH, Michailidis E, Lorenzi JCC, Mendoza P, Rutkowska M, Bednarski E, Gaebler C, Agudelo M, Cho A, Wang Z, Gazumyan A, Cipolla M, Caskey M, Robbiani DF, Nussenzweig MC, Rice CM, Hatziioannou T, Bieniasz PD. Measuring SARS-CoV-2 neutralizing antibody activity using pseudotyped and chimeric viruses. J Exp Med. 2020 Nov 2;217(11):e20201181. doi: 10.1084/jem.20201181.

  PMID: 32692348 RESULT

MeSH Terms

Conditions

COVID-19; Neoplasms

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mohamed Diaaeldin Hashem, MBBCh, MSc

  Children's Cancer Hospital Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Diaaeldin Hashem, MBBCh, MSc

CONTACT

+2-02-25351500; mohamed.diaaeldin@57357.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2021
• First Posted: December 29, 2021
• Study Start: January 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 29, 2021

Record last verified: 2021-12

Locations

EG (1)