Are SARS-CoV-2 Specific Antibodies a Correlate for Protection?
ImmCoV
1 other identifier
interventional
150
1 country
2
Brief Summary
The objectives of this study are (1) to determine the ex vivo neutralizing capacity and the longevity of SARS-CoV-2-specific Ab responses and (2) to measure the memory B-cell responses in a cohort of health care workers (HCW) recovering from severe, mild or asymptomatic infection. By focusing on HCW, a population that is at risk for re-infection during a second epidemic wave, the correlation between nAb levels and protection is investigated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2020
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2020
CompletedFirst Posted
Study publicly available on registry
July 14, 2020
CompletedStudy Start
First participant enrolled
July 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMarch 6, 2023
March 1, 2023
2.4 years
July 13, 2020
March 3, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
Antibody levels over time
Antibody levels over time
12 months
Antibody neutralizing capacity
Antibody neutralizing capacity
12 months
Memory B-cell function
Memory B-cell function
12 months
Antibody-dependent enhancement
Antibody-dependent enhancement
12 months
Secondary Outcomes (1)
Re-infection with SARS-CoV2
12 months
Study Arms (1)
antibody response and memory B-cell
EXPERIMENTALRegular blood draws to measure antibody responses and memory B-cell responses Regular swab collection to test for re-infection
Interventions
Assessing antibody responses, neutralizing capacity and memory B-cell function and their contribution to protection against re-infection
Eligibility Criteria
You may qualify if:
- Be diagnosed (PCR+) with COVID-19 between March-May 2020
- Be a permanent employee (HCW: nurse, physician, paramedical) of the study hospital
- Agree to complete a short questionnaire and be sampled 4 tubes of heparin whole blood every 3 months over a one-year period
- Have given their informed consent to participate
You may not qualify if:
- Persons in serious clinical condition, incompatible with the informed consent procedure
- Pregnant women
- Persons that have not been diagnosed with COVID-19
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institute of Tropical Medicine, Belgiumlead
- Jessa Hospitalcollaborator
- University Hospital, Antwerpcollaborator
- Universiteit Antwerpencollaborator
- Sciensanocollaborator
- Mensuracollaborator
Study Sites (2)
University Hospital Antwerp
Antwerp, 2000, Belgium
Jessa Hospital
Hasselt, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin K. Ariën, PhD
Institute of Tropical Medicine Antwerp
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2020
First Posted
July 14, 2020
Study Start
July 31, 2020
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
March 6, 2023
Record last verified: 2023-03