Severe Acute Respiratory Syndrome Clinical Trial
— Coro-BuddyOfficial title:
Prospective, Seroepidemiological, Non-invasive Cohort Study in Tübingen Children Age-stratified by Nursery and School Attendance
NCT number | NCT04581889 |
Other study ID # | Coro-Buddy |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 2, 2020 |
Est. completion date | July 31, 2022 |
Verified date | June 2022 |
Source | University Hospital Tuebingen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a prospective, longitudinal study to determine the incidence of SARS-COV-2 infection in children and adolescents by measuring specific antibodies in non-invasive saliva sampled in kindergartens and schools in a defined city area. The study includes an additional arm to validate the ELISA for anti-SARS-COV-2 reactive antibody measurements in saliva compared against blood collected in adult volunteers in a bimonthly follow-up period for 12 months.
Status | Completed |
Enrollment | 2380 |
Est. completion date | July 31, 2022 |
Est. primary completion date | July 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Year to 18 Years |
Eligibility | Inclusion Criteria: - Children from 1 months to 18 years - Written informed consent of the parent/legal guardian (study population is minor) - Written assent when children are = 12 years - Enrolled in a kita, kindergarden, primary, or secondary school located in Tübingen Adult population: - Individuals >18 years who recovered from a confirmed SARS-CoV-2 infection. - Or individuals > 18 years with an unknown status of previous SARS-CoV-2 infection Exclusion Criteria: - Unwilling to give consent |
Country | Name | City | State |
---|---|---|---|
Germany | Institute of Tropical Medicine | Tübingen | Deutschland |
Lead Sponsor | Collaborator |
---|---|
University Hospital Tuebingen |
Germany,
Azzi L, Carcano G, Gianfagna F, Grossi P, Gasperina DD, Genoni A, Fasano M, Sessa F, Tettamanti L, Carinci F, Maurino V, Rossi A, Tagliabue A, Baj A. Saliva is a reliable tool to detect SARS-CoV-2. J Infect. 2020 Jul;81(1):e45-e50. doi: 10.1016/j.jinf.2020.04.005. Epub 2020 Apr 14. — View Citation
Bi Q, Wu Y, Mei S, Ye C, Zou X, Zhang Z, Liu X, Wei L, Truelove SA, Zhang T, Gao W, Cheng C, Tang X, Wu X, Wu Y, Sun B, Huang S, Sun Y, Zhang J, Ma T, Lessler J, Feng T. Epidemiology and transmission of COVID-19 in 391 cases and 1286 of their close contacts in Shenzhen, China: a retrospective cohort study. Lancet Infect Dis. 2020 Aug;20(8):911-919. doi: 10.1016/S1473-3099(20)30287-5. Epub 2020 Apr 27. Erratum In: Lancet Infect Dis. 2020 Jul;20(7):e148. — View Citation
Hettegger P, Huber J, Passecker K, Soldo R, Kegler U, Nohammer C, Weinhausel A. High similarity of IgG antibody profiles in blood and saliva opens opportunities for saliva based serology. PLoS One. 2019 Jun 20;14(6):e0218456. doi: 10.1371/journal.pone.0218456. eCollection 2019. — View Citation
Hong H, Wang Y, Chung HT, Chen CJ. Clinical characteristics of novel coronavirus disease 2019 (COVID-19) in newborns, infants and children. Pediatr Neonatol. 2020 Apr;61(2):131-132. doi: 10.1016/j.pedneo.2020.03.001. Epub 2020 Mar 10. No abstract available. — View Citation
Macartney K, Quinn HE, Pillsbury AJ, Koirala A, Deng L, Winkler N, Katelaris AL, O'Sullivan MVN, Dalton C, Wood N; NSW COVID-19 Schools Study Team. Transmission of SARS-CoV-2 in Australian educational settings: a prospective cohort study. Lancet Child Adolesc Health. 2020 Nov;4(11):807-816. doi: 10.1016/S2352-4642(20)30251-0. Epub 2020 Aug 3. — View Citation
Perera RA, Mok CK, Tsang OT, Lv H, Ko RL, Wu NC, Yuan M, Leung WS, Chan JM, Chik TS, Choi CY, Leung K, Chan KH, Chan KC, Li KC, Wu JT, Wilson IA, Monto AS, Poon LL, Peiris M. Serological assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), March 2020. Euro Surveill. 2020 Apr;25(16):2000421. doi: 10.2807/1560-7917.ES.2020.25.16.2000421. — View Citation
To KK, Tsang OT, Yip CC, Chan KH, Wu TC, Chan JM, Leung WS, Chik TS, Choi CY, Kandamby DH, Lung DC, Tam AR, Poon RW, Fung AY, Hung IF, Cheng VC, Chan JF, Yuen KY. Consistent Detection of 2019 Novel Coronavirus in Saliva. Clin Infect Dis. 2020 Jul 28;71(15):841-843. doi: 10.1093/cid/ciaa149. — View Citation
Zimmermann P, Curtis N. COVID-19 in Children, Pregnancy and Neonates: A Review of Epidemiologic and Clinical Features. Pediatr Infect Dis J. 2020 Jun;39(6):469-477. doi: 10.1097/INF.0000000000002700. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | SARS-CoV-2 antibody persistence | SARS-CoV-2 antibodies persistence in peripheral blood and saliva | 12 months | |
Other | Antibodies presence in saliva samples | Saliva samples as alternative for the detection of antibodies against SARS-CoV-2 | 18 months | |
Primary | Incidence of SARS-CoV-2 infection in infants, children and adolescents | Identification of children that have been infected over different periods of time (summer, before winter and after winter) based on saliva samples | 12 months | |
Secondary | Incidence of SARS-CoV-2 | Change of incidence of SARS-CoV-2 infection in children during 2020/2021 | 12 months |
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