High-throughput Serological Testing of Antibodies Platform
NCT ID: NCT06939556
Last Updated: 2025-06-08
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
RECRUITING
Total Enrollment
152 participants
Study Classification
OBSERVATIONAL
Study Start Date
2025-04-15
Study Completion Date
2025-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
In the case of large emergency serosurveys, innovation in the sampling techniques is an often neglected, but relevant aspect to facilitate the enrolment of subjects in both adult and paediatric populations. Further, neutralization assays are the first line of response immediately after the emergence of a novel virus in the human population. This study aims at developing at IZSVe 384-format high-throughput neutralization assays for emerging and re-emerging respiratory viruses with pandemic potential to increase the preparedness capacity at both regional and national levels. This diagnostic platform will include the validation of Mitra VAMS devices for gathering blood samples for the diagnostic procedure. The platform will be tested and validated using adult subject-matched serum samples collected by venipuncture and finger-prick with volumetric tip microsampling devices (Mitra VAMS). This comparison will focus on the titration of antibodies against endemic viruses like influenza type A (i.e., seasonal influenza strains, like pdmH1N1 or H3N2) and SARS-CoV-2. The same serological assay will be developed to titrate neutralizing antibodies against emerging pathogens like avian influenza viruses of the H3 and H5 subtypes, Zika virus, and MERS-CoV.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Serology and Other Immunologic Response Tests in the Diagnosis of COVID-19 in Pediatrics
NCT05795790
COVID-19
UNKNOWN
Clinical Usefulness of a Multi-analyte Immunoassay for Distinguishing Bacterial and Viral Infections in Children
NCT06852846
Febrile Illness
ACTIVE_NOT_RECRUITING
NA
Evaluation of the Detection Performance of the N Antigenemia of SARS-CoV-2 in the General Population for the Diagnosis and Screening of COVID-19
NCT05092607
Respiratory Viral Infection
UNKNOWN
NA
Co-Sér: Serological Analysis and Viral Neutralization in People With a Documented COVID-19 Infection
NCT05000307
SARS-CoV Infection
Immune System Disorder
COMPLETED
NA
Use of Low-cost Molecular Diagnostic Techniques as a New Surveillance Model for Diseases Preventable by Vaccinations.
NCT06322277
Bacterial Infections
RECRUITING
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Orthomyxoviridae, Flaviviridae, and Coronaviridae are viral families from which a pandemic/epidemic agent is expected to emerge in the coming years. In particular, highly pathogenic avian influenza viruses of the H5N1 subtype and MERS-CoV are respiratory viruses that are known to cause sporadic infections in humans in vast areas of the world where these infections are endemic in animals. These pathogens are on the high-priority list of the World Health Organization given their potential to increase their fitness in humans, their ability to reassort/recombine with other respiratory agents, and the unpredictable potential to gain human-to-human transmission abilities. Zika and other exotic zoonotic flaviviruses like Dengue, Usutu, or Mayaro viruses are not respiratory pathogens, but the rising temperatures associated with climate change are making the European region a more favorable ecological space for the introduction and maintenance of these viruses.
The development of a serological high-throughput platform for mass screening is a fundamental element in increasing preparedness for pandemic scenarios. In the case of large emergency serosurveys, innovation in the sampling techniques is an often neglected but relevant aspect to facilitate the enrolment of subjects in both adult and paediatric populations. Venipuncture is considered the gold standard for sampling blood. Nonetheless, this method includes several important drawbacks: the great volume that is collected (exceeding 1 ml), its invasiveness, the need for a sterile environment as well as specialized personnel to perform it, and the potential risk of exposure to pathogens, which demands a great effort in sample preparation and shipping conditions (affecting costs) (reviewed in Bossi et al. 2024).
As a result, starting in 1963 with dry blood spots (DBSs), blood microsampling methods, that is, the collection of small volumes (≤150 μl) of capillary blood derived usually through a finger prick, have been proposed. Capillary sampling is a standard procedure for neonatal screening testing and diabetic patients, while venipuncture is the standard approach to blood sampling and, in particular, for those oriented to the screening of antibodies against infectious diseases. The finger and heel-prick techniques have been rarely adopted for the titration of neutralizing antibodies due to the limited volume of sera available and the cumbersome laboratory process required to recover antibodies (i.e., puncturing DBSs, eluting the spots overnight, etc.).
Microsampling devices, known as volumetric tip microsampling (VTM), represent a novel approach to sampling and self-sampling. These tools serve the same purpose as the DBS (i.e., filter papers), which has been commonly used for neonatal hematology, but with the advantage of the ease of automation and the standardization of sample volumes. Further, VTM can be particularly beneficial in remote non-specialized centers and domestic settings where venipuncture is not possible and where logistical impediments challenge the storage of samples.
VTM is a method that permits a correct quantification of the sample. Hematocrit, along with other parameters, such as humidity and drying conditions, influence spot size, spot homogeneity, and extraction recovery of analytes in DBS, making it inadequate for procedures that require quantification of analytes (reviewed in Thangavelu et al. 2023). Moreover, filter paper properties, a fundamental component of DBS, can introduce further bias by influencing "the maximum loading capacity, blood spreadability, chromatographic effects, analyte stability and recovery." (reviewed in Thangavelu et al. 2023).
During epidemic emergencies, laboratories rarely meet high-volume requests for the detection and titration of neutralizing antibodies due to technical and logistical constraints. Hence, there is a need to scale up laboratories' capacities to meet such requests. In the case of a hub for serological surveys, scaling up the existing techniques requires developments in the field of automation (i.e., the use of liquid-handling workstations) and the transition from a serological assay based on the standard 96-well plate to a 384-well plate technology. Working with the 384 format not only meets the need for capacity scale-up but also allows for a reduction in the sample's minimal working volume. Such a reduction of the working volumes would be a positive element for increasing the sensitivity of assays carried out on samples collected through VTM (i.e., avoiding elution steps to meet higher working volumes). Moreover, lower volumes of blood imply minimizing the distress associated with lengthy restraints of pediatric patients (i.e., one drop of blood rather than two or three).
There is a limited body of literature on the use of VTM as an alternative to DBS for the collection of capillary blood. VTM has been mainly compared to serum samples obtained by venipuncture regarding the performance of hemato-biochemical and metabolic profiling analyses. Only one study compared the performance of a neutralization assay targeting antibodies against the respiratory syncytial virus (RSV) using samples obtained by either venipuncture or with VTM, finding that VTM was an adequate device to collect and store the blood samples for viral neutralization assays (Terstappen et al., 2023).
Using a lentiviral expression system neutralization assay, Roper and co-authors proved in 2023 that DBS on filter paper delivered similar results to patient-matched sera in assessing the presence of neutralizing antibodies against SARS-CoV-2. Nonetheless, sensitivity issues were observed in connection to blood spot cut-out size variability. In 2021, Sancilio and co-authors relied on a surrogate virus neutralization test (sVNT) that quantified the inhibition of the interaction between SARS-CoV-2 S and human angiotensin-converting enzyme 2 receptor protein and demonstrated that responses in DBS from SARS-CoV-2 PCR positive and negative samples had a concordance correlation of 99% to paired sera.
Among different blood microsampling methods, "the Mitra device, which comprises a plastic sampler attached to a proprietary hydrophilic polymer tip based on Mitra's patented volumetric absorptive microsampling (VAMS®) technology" (Thangavelu et al. 2023) stands out because it allows for higher volumes of blood to be collected than other VTM devices. Mitra devices are compatible with 96-Autoracks and automated liquid-handling systems, making them exceptionally indicated for high-throughput methods. According to Kok and Fillet's review (2018), "\[a\] cross-laboratory study showed that the VAMS technology enables the collection of an accurate and precise blood volume regardless of the haematocrit." Like other microsampling devices, Mitra VAMS allows for self-sampling and is minimally invasive. However, beyond these advantages, these devices have further ones: compared to most other microsampling devices, one can collect greater blood volumes; and, as noted above, they are exceptionally compatible with high-throughput processes. These traits make them notable candidates for pandemic preparedness and response. Indeed, Mitra VAMS have been used for procedures aiming at detecting and titrating antibodies against SARS-CoV-2 (e.g., Johnson et al. 2022; Whitcombe et al., 2020; Wang et al. 2020; Klumpp-Thomas et al. 2021).
This study aims to develop at IZSVe 384-format high-throughput neutralization assays for emerging and re-emerging respiratory viruses with pandemic potential to increase the preparedness capacity at both regional and national levels. This diagnostic platform will include the validation of Mitra VAMS devices for gathering blood samples for the diagnostic procedure.
Primary objective: Validate the use in the diagnostic practice of microsampling devices (Mitra VAMS) for the detection of neutralizing antibodies for viral infectious diseases of epidemic nature in a real-world scenario for adult and pediatric populations.
Secondary objective: Develop a high-throughput serological platform for the detection of neutralizing antibodies against avian influenza strains associated with pandemic potential (H5N1, H3N8, H9N2, etc), MERS-CoV and Zika virus.
This study will be a cross-sectional study. It will allow us to evaluate the diagnostic performance of the assay in a real-world setting and to identify potential confounding variables. To validate the microsampling device, we will enroll 62 adult and 90 pediatric patients who will be subjected to venipuncture for either routine diagnostic purposes or routine medical examinations by the occupational physician. For this reason, venipuncture procedures should not be considered as an intervention. In this study, the intervention will consist only of capillary sampling with a lancet (i.e., finger prick). This comparison will focus on the titration of antibodies against endemic viruses like influenza type A (i.e., seasonal influenza strains, like pdmH1N1 or H3N2) and SARS-CoV-2. The same serological assay will be developed to titrate neutralising antibodies against emerging pathogens like avian influenza viruses of the H3 and H5 subtypes, Zika virus, and MERS-CoV.
The study is part of the VERDI (SARS-coV2 Variants Evaluation in pRegnancy and paeDIatrics cohorts) project funded by the European Union.
The development of a serological high-throughput platform for mass screening is a fundamental element in increasing preparedness for pandemic scenarios. In the case of large emergency serosurveys, innovation in the sampling techniques is an often neglected but relevant aspect to facilitate the enrolment of subjects in both adult and paediatric populations. Venipuncture is considered the gold standard for sampling blood. Nonetheless, this method includes several important drawbacks: the great volume that is collected (exceeding 1 ml), its invasiveness, the need for a sterile environment as well as specialized personnel to perform it, and the potential risk of exposure to pathogens, which demands a great effort in sample preparation and shipping conditions (affecting costs) (reviewed in Bossi et al. 2024).
As a result, starting in 1963 with dry blood spots (DBSs), blood microsampling methods, that is, the collection of small volumes (≤150 μl) of capillary blood derived usually through a finger prick, have been proposed. Capillary sampling is a standard procedure for neonatal screening testing and diabetic patients, while venipuncture is the standard approach to blood sampling and, in particular, for those oriented to the screening of antibodies against infectious diseases. The finger and heel-prick techniques have been rarely adopted for the titration of neutralizing antibodies due to the limited volume of sera available and the cumbersome laboratory process required to recover antibodies (i.e., puncturing DBSs, eluting the spots overnight, etc.).
Microsampling devices, known as volumetric tip microsampling (VTM), represent a novel approach to sampling and self-sampling. These tools serve the same purpose as the DBS (i.e., filter papers), which has been commonly used for neonatal hematology, but with the advantage of the ease of automation and the standardization of sample volumes. Further, VTM can be particularly beneficial in remote non-specialized centers and domestic settings where venipuncture is not possible and where logistical impediments challenge the storage of samples.
VTM is a method that permits a correct quantification of the sample. Hematocrit, along with other parameters, such as humidity and drying conditions, influence spot size, spot homogeneity, and extraction recovery of analytes in DBS, making it inadequate for procedures that require quantification of analytes (reviewed in Thangavelu et al. 2023). Moreover, filter paper properties, a fundamental component of DBS, can introduce further bias by influencing "the maximum loading capacity, blood spreadability, chromatographic effects, analyte stability and recovery." (reviewed in Thangavelu et al. 2023).
During epidemic emergencies, laboratories rarely meet high-volume requests for the detection and titration of neutralizing antibodies due to technical and logistical constraints. Hence, there is a need to scale up laboratories' capacities to meet such requests. In the case of a hub for serological surveys, scaling up the existing techniques requires developments in the field of automation (i.e., the use of liquid-handling workstations) and the transition from a serological assay based on the standard 96-well plate to a 384-well plate technology. Working with the 384 format not only meets the need for capacity scale-up but also allows for a reduction in the sample's minimal working volume. Such a reduction of the working volumes would be a positive element for increasing the sensitivity of assays carried out on samples collected through VTM (i.e., avoiding elution steps to meet higher working volumes). Moreover, lower volumes of blood imply minimizing the distress associated with lengthy restraints of pediatric patients (i.e., one drop of blood rather than two or three).
There is a limited body of literature on the use of VTM as an alternative to DBS for the collection of capillary blood. VTM has been mainly compared to serum samples obtained by venipuncture regarding the performance of hemato-biochemical and metabolic profiling analyses. Only one study compared the performance of a neutralization assay targeting antibodies against the respiratory syncytial virus (RSV) using samples obtained by either venipuncture or with VTM, finding that VTM was an adequate device to collect and store the blood samples for viral neutralization assays (Terstappen et al., 2023).
Using a lentiviral expression system neutralization assay, Roper and co-authors proved in 2023 that DBS on filter paper delivered similar results to patient-matched sera in assessing the presence of neutralizing antibodies against SARS-CoV-2. Nonetheless, sensitivity issues were observed in connection to blood spot cut-out size variability. In 2021, Sancilio and co-authors relied on a surrogate virus neutralization test (sVNT) that quantified the inhibition of the interaction between SARS-CoV-2 S and human angiotensin-converting enzyme 2 receptor protein and demonstrated that responses in DBS from SARS-CoV-2 PCR positive and negative samples had a concordance correlation of 99% to paired sera.
Among different blood microsampling methods, "the Mitra device, which comprises a plastic sampler attached to a proprietary hydrophilic polymer tip based on Mitra's patented volumetric absorptive microsampling (VAMS®) technology" (Thangavelu et al. 2023) stands out because it allows for higher volumes of blood to be collected than other VTM devices. Mitra devices are compatible with 96-Autoracks and automated liquid-handling systems, making them exceptionally indicated for high-throughput methods. According to Kok and Fillet's review (2018), "\[a\] cross-laboratory study showed that the VAMS technology enables the collection of an accurate and precise blood volume regardless of the haematocrit." Like other microsampling devices, Mitra VAMS allows for self-sampling and is minimally invasive. However, beyond these advantages, these devices have further ones: compared to most other microsampling devices, one can collect greater blood volumes; and, as noted above, they are exceptionally compatible with high-throughput processes. These traits make them notable candidates for pandemic preparedness and response. Indeed, Mitra VAMS have been used for procedures aiming at detecting and titrating antibodies against SARS-CoV-2 (e.g., Johnson et al. 2022; Whitcombe et al., 2020; Wang et al. 2020; Klumpp-Thomas et al. 2021).
This study aims to develop at IZSVe 384-format high-throughput neutralization assays for emerging and re-emerging respiratory viruses with pandemic potential to increase the preparedness capacity at both regional and national levels. This diagnostic platform will include the validation of Mitra VAMS devices for gathering blood samples for the diagnostic procedure.
Primary objective: Validate the use in the diagnostic practice of microsampling devices (Mitra VAMS) for the detection of neutralizing antibodies for viral infectious diseases of epidemic nature in a real-world scenario for adult and pediatric populations.
Secondary objective: Develop a high-throughput serological platform for the detection of neutralizing antibodies against avian influenza strains associated with pandemic potential (H5N1, H3N8, H9N2, etc), MERS-CoV and Zika virus.
This study will be a cross-sectional study. It will allow us to evaluate the diagnostic performance of the assay in a real-world setting and to identify potential confounding variables. To validate the microsampling device, we will enroll 62 adult and 90 pediatric patients who will be subjected to venipuncture for either routine diagnostic purposes or routine medical examinations by the occupational physician. For this reason, venipuncture procedures should not be considered as an intervention. In this study, the intervention will consist only of capillary sampling with a lancet (i.e., finger prick). This comparison will focus on the titration of antibodies against endemic viruses like influenza type A (i.e., seasonal influenza strains, like pdmH1N1 or H3N2) and SARS-CoV-2. The same serological assay will be developed to titrate neutralising antibodies against emerging pathogens like avian influenza viruses of the H3 and H5 subtypes, Zika virus, and MERS-CoV.
The study is part of the VERDI (SARS-coV2 Variants Evaluation in pRegnancy and paeDIatrics cohorts) project funded by the European Union.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Diagnostics
Pandemic Response
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
OTHER
Study Time Perspective
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Adult Cohort
20-65 years of age
No interventions assigned to this group
Pediatric Cohort
2-10 years of age
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
Adult Cohort - between 20 and 65 years of age Pediatric Cohort - between 2 and 10 years of age Signed consent form by the subject for adults or by caregivers for children
Exclusion Criteria
1. subjects with an immunocompromised status, such as immunodeficiency disorders or those undergoing immunosuppressant treatments
2. subjects with underlying chronic inflammatory conditions (i.e., autoimmune disorders, chronic gastrointestinal, and rheumatic conditions)
3. subjects who have received immunomodulatory treatment within the past year.
2. subjects with underlying chronic inflammatory conditions (i.e., autoimmune disorders, chronic gastrointestinal, and rheumatic conditions)
3. subjects who have received immunomodulatory treatment within the past year.
Minimum Eligible Age
2 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Union
OTHER
Sponsor Role
collaborator
VERDI Consortium
UNKNOWN
Sponsor Role
collaborator
University of Padova
OTHER
Sponsor Role
collaborator
Istituto Zooprofilattico Sperimentale delle Venezie
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Francesco Bonfante
Head of the Laboratory of Experimental Animal Models at the SCS6 - Experimental Virology, Istituto Zooprofilattico Sperimentale delle Venezie (IZSVe)
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Istituto Zooprofilattico Sperimentale delle Venezie
Padua, Italy, Italy
Site Status
RECRUITING
Padova University Hospital, Department of Women's and Children's Health
Padua, Italy, Italy
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Italy
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Head of the Laboratory of Experimental Animal Models IZSVe
Role: CONTACT
+39 049 8084101-102
Olga S Munoz Pogoreltseva, DVM, MSc, PhD in Public Health
Role: CONTACT
+39 049 8084101-102
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Whitcombe AL, McGregor R, Craigie A, James A, Charlewood R, Lorenz N, Dickson JM, Sheen CR, Koch B, Fox-Lewis S, McAuliffe G, Roberts SA, Morpeth SC, Taylor S, Webb RH, Jack S, Upton A, Ussher JE, Moreland NJ. Comprehensive analysis of SARS-CoV-2 antibody dynamics in New Zealand. Clin Transl Immunology. 2021 Mar 14;10(3):e1261. doi: 10.1002/cti2.1261. eCollection 2021.
Reference Type
BACKGROUND
Wang Y, Sun J, Li X, Zhu A, Guan W, Sun DQ, Gan M, Niu X, Dai J, Zhang L, Zhang Z, Shi Y, Huang S, Mok CKP, Yang Z, Wang Z, Tan W, Li Y, Chen L, Chen R, Peiris M, Zhong N, Zhao J, Huang J, Zhao J. Increased Pathogenicity and Virulence of Middle East Respiratory Syndrome Coronavirus Clade B In Vitro and In Vivo. J Virol. 2020 Jul 16;94(15):e00861-20. doi: 10.1128/JVI.00861-20. Print 2020 Jul 16.
Reference Type
BACKGROUND
Thangavelu MU, Wouters B, Kindt A, Reiss IKM, Hankemeier T. Blood microsampling technologies: Innovations and applications in 2022. Anal Sci Adv. 2023 May 18;4(5-6):154-180. doi: 10.1002/ansa.202300011. eCollection 2023 Jul.
Reference Type
BACKGROUND
Terstappen J, Delemarre EM, Versnel A, White JT, Derrien-Colemyn A, Ruckwardt TJ, Bont LJ, Mazur NI. RSV Neutralizing Antibodies in Dried Blood. J Infect Dis. 2024 Jul 25;230(1):e93-e101. doi: 10.1093/infdis/jiad543.
Reference Type
BACKGROUND
Sancilio AE, D'Aquila RT, McNally EM, Velez MP, Ison MG, Demonbreun AR, McDade TW. A surrogate virus neutralization test to quantify antibody-mediated inhibition of SARS-CoV-2 in finger stick dried blood spot samples. Sci Rep. 2021 Jul 28;11(1):15321. doi: 10.1038/s41598-021-94653-z.
Reference Type
BACKGROUND
Roper KJ, Thomas J, Albalawi W, Maddocks E, Dobson S, Alshehri A, Barone FG, Baltazar M, Semple MG, Ho A, Turtle L; ISARIC4C Consortium; Paxton WA, Pollakis G. Quantifying neutralising antibody responses against SARS-CoV-2 in dried blood spots (DBS) and paired sera. Sci Rep. 2023 Sep 11;13(1):15014. doi: 10.1038/s41598-023-41928-2.
Reference Type
BACKGROUND
Kok MGM, Fillet M. Volumetric absorptive microsampling: Current advances and applications. J Pharm Biomed Anal. 2018 Jan 5;147:288-296. doi: 10.1016/j.jpba.2017.07.029. Epub 2017 Jul 27.
Reference Type
BACKGROUND
Klumpp-Thomas C, Kalish H, Drew M, Hunsberger S, Snead K, Fay MP, Mehalko J, Shunmugavel A, Wall V, Frank P, Denson JP, Hong M, Gulten G, Messing S, Hicks J, Michael S, Gillette W, Hall MD, Memoli MJ, Esposito D, Sadtler K. Standardization of ELISA protocols for serosurveys of the SARS-CoV-2 pandemic using clinical and at-home blood sampling. Nat Commun. 2021 Jan 4;12(1):113. doi: 10.1038/s41467-020-20383-x.
Reference Type
BACKGROUND
Johnson, Joseph M., Syrena C. Fernandes, Danica L. Wuelfing, Aaron R. Baillargeon, Evan L. MacLure, Soyoon Hwang, Andrew J. Ball, et al. 2022. "Quantifying Post-Vaccination Protective Anti-SARS-CoV-2 IgG Antibodies in Blood and Saliva with a Fully Automated, High Throughput Digital Immunoassay". Preprint. Infectious Diseases (except HIV/AIDS). https://doi.org/10.1101/2022.01.21.22269165
Reference Type
BACKGROUND
Bossi E, Limo E, Pagani L, Monza N, Serrao S, Denti V, Astarita G, Paglia G. Revolutionizing Blood Collection: Innovations, Applications, and the Potential of Microsampling Technologies for Monitoring Metabolites and Lipids. Metabolites. 2024 Jan 11;14(1):46. doi: 10.3390/metabo14010046.
Reference Type
BACKGROUND
Related Links
Access external resources that provide additional context or updates about the study.
https://verdiproject.org/
This is the website of the umbrella project.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Nr. CE_IZSVE 10/2024
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
A Specific miRNA Encoded by SARS-CoV-2 as a Diagnostic Tool to Predict Disease Severity in COVID-19 Patients
NCT05739513
COMPLETED
NA
Pediatric Infectious Disease Precision Medicine Using Sequencing Evaluation of CSF
NCT03796546
COMPLETED
Coronavirus Pediatric Serological Study
NCT05128435
COMPLETED
Neutralizing Power of Anti-SARS-CoV-2 (Anti-COVID-19) Serum Antibodies
NCT05315583
TERMINATED
NA
Rapid Diagnostic Tests and Clinical/Laboratory Predictors of Tropical Diseases In Patients With Persistent Fever in Cambodia, Nepal, Democratic Republic of the Congo and Sudan (NIDIAG-Fever)
NCT01766830
COMPLETED
NA
Evaluation of the Acceptance of the Anti-COVID-19 Vaccine Offer Among Pregnant Women
NCT05729191
COMPLETED
Evaluation of Serological Techniques for Screening for COVID-19 Infection at the University Hospital of Rouen
NCT04707833
UNKNOWN
NA
Immune Responses to COVID-19; Isolation of Neutralizing Antibodies for Therapeutics and Vaccine.
NCT04596098
COMPLETED
Consequences of COVID-19 Infection for Child Health and Wellbeing: Protocol for a Prospective, Observational, Longitudinal Study in Children
NCT05799508
UNKNOWN
Serological Profile of Children and Young Adolescents With at Least One COVID-19 Diagnosed Family Member
NCT04649944
UNKNOWN
Factors Associated With a Positive SARS-CoV-2 Serology in Contact Subjects at High/Moderate Risk of Coronavirus SARS-CoV-2 Infection. COVID-19.
NCT04322279
TERMINATED
Serology COVID-19 From the Cornwall Hospital Union
NCT04363593
COMPLETED
NA
TURN-COVID Biobank: The Dutch Cohort Study for the Evaluation of the Use of Neutralizing Monoclonal Antibodies and Other Antiviral Agents Against SARS-CoV-2
NCT05195060
COMPLETED
Detection of COVID-19 in Saliva Collection
NCT04386551
COMPLETED
Evaluating Clinical Parameters of COVID-19 in Pregnancy
NCT04470583
UNKNOWN
Immune Response to Anti COVID-19 Vaccine in Immunocompromised Patients: a Cohort Study
NCT04888793
COMPLETED
Clinical and Immunologic Impact of Perinatal SARS-CoV-2 (COVID-19) Infection
NCT04362956
COMPLETED
Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala
NCT05314816
COMPLETED
NA
Rapid Molecular Diagnosis and Detection of Emerging Infectious Diseases in Patients With Tropical Fever (Tropifever)
NCT06539325
RECRUITING
NA
Determination of the Hemoadsorption Impact as Adjunctive Treatment Upon the Support Therapy of COVID-19
NCT04518969
COMPLETED
NA
COVID-19 Serologies Among Healthcare Workers at CHSD (SERO2)
NCT06989307
COMPLETED
Diagnostic Accuracy of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients
NCT03052088
COMPLETED
Diagnosis of Septicaemia by Detection of Microbial DNA in Blood in Severe Infections
NCT00709358
COMPLETED
PHASE4
A Retrospective, Blinded Validation of a Host-response Based Diagnostics
NCT01911143
COMPLETED
Rapid Salivary Test to Detect SARS-CoV-2 (COVID-19)
NCT04357327
COMPLETED
NA