Children With CancerNCT05172063
Persistent SARS-CoV-2 Infection in Children With Cancer and Impaired Immune Responsiveness
An observational study of Children With Cancer and SARS-CoV-2 Infection, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Children With Cancer, SARS-CoV-2 Infection
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Conditions
- Children With Cancer, SARS-CoV-2 Infection
- Keywords
- Children, Cancer, SARS-CoV-2, Adaptive Immune Response
- Medical subject headings
- COVID-19, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 antibody titers
Measured: Three months
Different subsets of immune cells (neutrophils, dendritic cells, B- and T- lymphocytes)
Measured: Three months
Secondary outcomes (2)
Sequence viral variants in the persistent SARS-COV-2 infected group
Measured: Three months
Assess the association between the emergence of viral variants and mutations and strain virulence and clinical outcome
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study startJan 2022 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Children With CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Cancer Hospital Egypt 57357
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Centre, Egypt, Pfizer
- Responsible party
- Sponsor
- Investigators
- Mohamed Diaaeldin Hashem, MBBCh, MSc, Principal investigator, Children's Cancer Hospital Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172063
- Sponsor's protocol ID
- CCHE-Persistent SARS-CoV-2
- Status last verified
- Dec 2021
- First submitted
- 26 Dec 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32374370Avanzato 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.
PubMed 33248470Baang 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.
PubMed 33089317Choi 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.
PubMed 33176080Aydillo 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.
PubMed 33259154Truong 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.
PubMed 33915337Turner 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.
PubMed 33488630Gomaa 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.
PubMed 33329484Gomaa 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.
PubMed 33705496Schmidt 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.
PubMed 32692348
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent SARS-CoV-2 Infection in Children With Cancer and Impaired Immune Responsiveness
- ClinicalTrials.gov ID
- NCT05172063
- Acronym / sponsor ID
- CCHE-Persistent SARS-CoV-2
- Conditions
- Children With Cancer, SARS-CoV-2 Infection
- Keywords
- Children, Cancer, SARS-CoV-2, Adaptive Immune Response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Children's Cancer Hospital Egypt 57357University, hospital or other
- Collaborators
- National Research Centre, Egypt, Pfizer
- Study start
- Jan 2022 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SARS-CoV-2 antibody titers
Time frame: Three months
Different subsets of immune cells (neutrophils, dendritic cells, B- and T- lymphocytes)
Time frame: Three months
2 secondary outcomes
Sequence viral variants in the persistent SARS-COV-2 infected group
Time frame: Three months
Assess the association between the emergence of viral variants and mutations and strain virulence and clinical outcome
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Results publication: PubMed 32374370Sethuraman 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.
- Results publication: PubMed 33248470Avanzato 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.
- Results publication: PubMed 33089317Baang 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.
- Results publication: PubMed 33176080Choi 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.
- Results publication: PubMed 33259154Aydillo 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.
- Results publication: PubMed 33915337Truong 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.
- Results publication: PubMed 33488630Turner 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.
- Results publication: PubMed 33329484Gomaa 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.
- Results publication: PubMed 33705496Gomaa 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.
- Results publication: PubMed 32692348Schmidt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Diaaeldin Hashem, MBBCh, MSc principal investigator
Children's Cancer Hospital Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children With Cancer and SARS-CoV-2 Infection, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Diaaeldin Hashem, MBBCh, MSc (+2-02-25351500 ext. 7204, mohamed.diaaeldin@57357.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 antibody titers (time frame: Three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05172063, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.