MedDataX Logo

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

NCT ID: NCT05172063

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-31

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Children With Cancer SARS-CoV-2 Infection

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Children Cancer SARS-CoV-2 Adaptive Immune Response

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Persistent SARS-CoV-2 Infection Group

Pediatric Cancer patients with persistent SARS-CoV-2 infection

No interventions assigned to this group

SARS-CoV-2 Clearance Group

Pediatric Cancer patients who tested negative for SARS-CoV-2 within 14 days of diagnosis.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Research Centre, Egypt

OTHER

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

Children's Cancer Hospital Egypt 57357

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mohamed Diaaeldin Hashem, MBBCh, MSc

Role: PRINCIPAL_INVESTIGATOR

Children's Cancer Hospital Egypt

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Cancer Hospital Egypt 57357 Cairo, Egypt

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohamed Diaaeldin Hashem, MBBCh, MSc

Role: CONTACT

Phone: +2-02-25351500

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 32374370 (View on PubMed)

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.

Reference Type RESULT
PMID: 33248470 (View on PubMed)

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.

Reference Type RESULT
PMID: 33089317 (View on PubMed)

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.

Reference Type RESULT
PMID: 33176080 (View on PubMed)

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.

Reference Type RESULT
PMID: 33259154 (View on PubMed)

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.

Reference Type RESULT
PMID: 33915337 (View on PubMed)

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.

Reference Type RESULT
PMID: 33488630 (View on PubMed)

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.

Reference Type RESULT
PMID: 33329484 (View on PubMed)

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.

Reference Type RESULT
PMID: 33705496 (View on PubMed)

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.

Reference Type RESULT
PMID: 32692348 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CCHE-Persistent SARS-CoV-2

Identifier Type: -

Identifier Source: org_study_id