SARS-CoV-2 InfectionMuCoNCT04590352
Mucosal Immunity Against SARS-CoV-2 Infection in COVID-19 Patients
An observational study of SARS-CoV-2 Infection, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
In this study nasal fluid (mucosal lining fluid), nose and throat swabs and blood was collected from patients with a confirmed SARS-CoV-2 infection who remained in home isolation, as well as from their household contacts who remained in home quarantine. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- nasopharyngeal and throat swab, collection of mucosal lining fluid and blood collection via fingerprick
- Type of treatment
- Surgery or procedure
- How many people
- 187 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Mar 2020to 13 May 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: laboratory confirmed Sars-Cov-2 cases and their household contacts.
Who may be able to join
- Index case:
- Laboratory-confirmed case of SARS-CoV-2, with a positive indication for home isolation, and;
- With at least 2 household contacts remaining in home quarantine at the same address
- Household contacts For each index case, the study will seek to recruit as many household contacts as possible in the same house as the index case. All household contacts of the index case remaining in home quarantine in the same house as the index case will be asked to participate.
Who cannot join
- Covid-19 patients with a negative indication for home isolation, or having less than 2 household contacts remaining in home quarantine at the same address. For fingerprick blood collection, participants who have a medical indication against fingerprick blood collection will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mucosal Immunity in Patients Diagnosed With SARS-CoV-2 Infection and Their Household Contacts
In this study nasal fluid (mucosal lining fluid), nose and throat swabs and blood was collected from patients with a confirmed SARS-CoV-2 infection who remained in home isolation, as well as from their household contacts who remained in home quarantine. On the collected nose and throat swabs a coronavirus PCR was performed. Antibodies against SARS-CoV-2 were measured in the mucosal lining fluid and blood samples.
Read the detailed description
Objective:
Primary Objective: to analyse the development of mucosal immunity against SARS-CoV-2 in nasal fluid of Covid-19 patients and their household contacts
Secondary Objective(s):
- To descriptively analyse the correlation of mucosal antibodies with viral diagnostics and disease symptoms
- To determine the correlation between mucosal and serum antibody levels
- To study the functionality of serum and mucosal antibodies
Study design: A single-site, observational, prospective cohort study among COVID-19 patients and their household contacts Study population: The study will be conducted among COVID-19 patients with a laboratory-confirmed infection with SARS-CoV-2, as well as household contacts remaining in home quarantine at the same address, among secondary and tertiary hospital careworkers in the provinces of Gelderland and Noord-Brabant in The Netherlands.
Intervention (if applicable): N/A
Main study parameters/endpoints:
Mucosal antibodies: descriptive analysis of SARS-CoV-2 IgG, IgA, IgM and IgD concentrations in nasal fluid at the various collection moments.
Viral diagnostics: presence of SARS-CoV-2 in diagnostic specimens collected at inclusion visit.
Disease symptoms: presence of respiratory complaints in participants. Serum antibodies: descriptive analysis of SARS-CoV-antibody concentrations in serum at day 28 Antibody functionality: descriptive analysis of antibody functionality of serum and nasal fluid samples, including virus neutralization
- Conditions
- SARS-CoV-2 Infection
- Being tested
- nasopharyngeal and throat swab, collection of mucosal lining fluid, blood collection via fingerprick
- Keywords
- SARS-CoV-2, household contacts, mucosal immunitiy, antibodies
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasopharyngeal and throat swabProcedure or surgery
diagnostic specimens via nasopharyngeal swab and throat swab were collected following the current standard operating procedures.
collection of mucosal lining fluidProcedure or surgery
MLF will be collected via nasal absorption at the inclusion visit by study staff and four more time points by the parents or by the children themselves. Nasal absorption is performed by maneuvering a strip of synthetic absorptive matrices (SAM) into the lumen of the nostril, avoiding rubbing against the nasal mucosa. The outside of the nose is then pressed with a finger to cause apposition of the SAM against the mucosa.
blood collection via fingerprickProcedure or surgery
Participants will be asked to wash their hands with soap and warm water. The procedure involves cleaning the ball of the fingertip with an alcohol swab, then using a sterile disposable lancet to pierce the skin (BD Microtainer Lancet or similar). The lancet is placed in a spring-loaded device, which propels the lancet a fixed distance (a few mm) into the skin when the trigger is pressed. Approximately 10-20 drops of blood (0.3 ml) will then be collected with a sterile capillary tube. The participant is given a cotton wool pad to mop up any extra blood, and an elastoplast-type bandage is placed over the finger if necessary. Fingerprick blood samples will only be collected from participants older than 6 months at 28-32 days after the first home visit (d0). Lancet length will be adjusted for age (2.0 mm for participants 8 years and older, 1.5 mm for participants older than 6 months and younger than 8 years).
| Study group | Role | What they receive |
|---|---|---|
| Index case and household contacts | * nasophryngeal and throat swab at day 0.
* collection of mucosal lining fluid: day 0, 7, 14, 28 for index case and day 0, 3, 6, 28 for household contacts.
* fingerprick at day 28 (optional).
* daily record of symptoms from day 0-28. Receives: Procedure: nasopharyngeal and throat swab; Procedure: collection of mucosal lining fluid; Procedure: blood collection via fingerprick |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucosal antibodies
Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid
Measured: Day 0
Mucosal antibodies
Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid
Measured: Day 3 (index cases)
Mucosal antibodies
Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid
Measured: Day 6 (index cases)
Mucosal antibodies
Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid
Measured: Day 7 (household contacts)
Mucosal antibodies
Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid
Measured: Day 14 (household contacts)
Mucosal antibodies in all participants
Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid
Measured: Day 28
Secondary outcomes (8)
SARS-CoV-2 infection
SARS-CoV-2 PCR on nasopharyngeal swab and throat swab
Measured: day 0
Serum antibodies
Descriptive analysis of SARS-CoV-2 antibody concentrations in serum at day 28.
Measured: day 28
Functional antibody assays
Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies
Measured: Day 0
Functional antibody assays
Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies
Measured: Day 3 (index cases)
Functional antibody assays
Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies
Measured: Day 6 (index cases)
Functional antibody assays
Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies
Measured: Day 7 (household contacts)
Functional antibody assays
Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies
Measured: Day 14 (household contacts)
Functional antibody assays
Descriptive analysis of the functionality of SARS-CoV-2 mucosal and serum antibodies
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start26 Mar 2020
- Primary completion13 May 2020
- Study completion13 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dimitri Diavatopoulos, Dr, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590352
- Sponsor's protocol ID
- 2020-6342
- Other IDs
- NL73418.091.20
- Acronym
- MuCo
- Status last verified
- Jul 2020
- First submitted
- 27 Aug 2020
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Froberg J, Koomen VJCH, van der Gaast-de Jongh CE, Philipsen R, GeurtsvanKessel CH, de Vries RD, Baas MC, van der Molen RG, de Jonge MI, Hilbrands LB, Huynen MA, Diavatopoulos DA. Primary Exposure to SARS-CoV-2 via Infection or Vaccination Determines Mucosal Antibody-Dependent ACE2 Binding Inhibition. J Infect Dis. 2024 Jan 12;229(1):137-146. doi: 10.1093/infdis/jiad385.
PubMed 37675756
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mucosal Immunity in Patients Diagnosed With SARS-CoV-2 Infection and Their Household Contacts
- ClinicalTrials.gov ID
- NCT04590352
- Acronym / sponsor ID
- MuCo / 2020-6342
- Conditions
- SARS-CoV-2 Infection
- Keywords
- SARS-CoV-2, household contacts, mucosal immunitiy, antibodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 26 Mar 2020 (actual)
- Primary completion
- 13 May 2020 (actual)
- Study completion
- 13 May 2020 (actual)
- First posted
- 19 Oct 2020 (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.
In this study nasal fluid (mucosal lining fluid), nose and throat swabs and blood was collected from patients with a confirmed SARS-CoV-2 infection who remained in home isolation, as well as from their household contacts who remained in home quarantine. On the collected nose and throat swabs a coronavirus PCR was performed. Antibodies against SARS-CoV-2 were measured in the mucosal lining fluid and blood samples.
Detailed description
Objective:
Primary Objective: to analyse the development of mucosal immunity against SARS-CoV-2 in nasal fluid of Covid-19 patients and their household contacts
Secondary Objective(s):
- To descriptively analyse the correlation of mucosal antibodies with viral diagnostics and disease symptoms
- To determine the correlation between mucosal and serum antibody levels
- To study the functionality of serum and mucosal antibodies
Study design: A single-site, observational, prospective cohort study among COVID-19 patients and their household contacts Study population: The study will be conducted among COVID-19 patients with a laboratory-confirmed infection with SARS-CoV-2, as well as household contacts remaining in home quarantine at the same address, among secondary and tertiary hospital careworkers in the provinces of Gelderland and Noord-Brabant in The Netherlands.
Intervention (if applicable): N/A
Main study parameters/endpoints:
Mucosal antibodies: descriptive analysis of SARS-CoV-2 IgG, IgA, IgM and IgD concentrations in nasal fluid at the various collection moments.
Viral diagnostics: presence of SARS-CoV-2 in diagnostic specimens collected at inclusion visit.
Disease symptoms: presence of respiratory complaints in participants. Serum antibodies: descriptive analysis of SARS-CoV-antibody concentrations in serum at day 28 Antibody functionality: descriptive analysis of antibody functionality of serum and nasal fluid samples, including virus neutralization
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Index case and household contacts | – | Procedure: nasopharyngeal and throat swab, Procedure: collection of mucosal lining fluid, Procedure: blood collection via fingerprick* nasophryngeal and throat swab at day 0. * collection of mucosal lining fluid: day 0, 7, 14, 28 for index case and day 0, 3, 6, 28 for household contacts. * fingerprick at day 28 (optional). * daily record of symptoms from day 0-28. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- laboratory confirmed Sars-Cov-2 cases and their household contacts.
Key inclusion criteria (4 listed)
- Index case:
- Household contacts For each index case, the study will seek to recruit as many household contacts as possible in the same house as the index case. All household contacts of the index case remaining in home quarantine in the same house as the index case will be asked to participate.
Key exclusion criteria (1 listed)
- Covid-19 patients with a negative indication for home isolation, or having less than 2 household contacts remaining in home quarantine at the same address. For fingerprick blood collection, participants who have a medical indication against fingerprick blood collection will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasopharyngeal and throat swabdiagnostic specimens via nasopharyngeal swab and throat swab were collected following the current standard operating procedures. | Procedure or surgery | Index case and household contacts |
| collection of mucosal lining fluidMLF will be collected via nasal absorption at the inclusion visit by study staff and four more time points by the parents or by the children themselves. Nasal absorption is performed by maneuvering a strip of synthetic absorptive matrices (SAM) into the lumen of the nostril, avoiding rubbing against the nasal mucosa. The outside of the nose is then pressed with a finger to cause apposition of the SAM against the mucosa. | Procedure or surgery | Index case and household contacts |
| blood collection via fingerprickParticipants will be asked to wash their hands with soap and warm water. The procedure involves cleaning the ball of the fingertip with an alcohol swab, then using a sterile disposable lancet to pierce the skin (BD Microtainer Lancet or similar). The lancet is placed in a spring-loaded device, which propels the lancet a fixed distance (a few mm) into the skin when the trigger is pressed. Approximately 10-20 drops of blood (0.3 ml) will then be collected with a sterile capillary tube. The participant is given a cotton wool pad to mop up any extra blood, and an elastoplast-type bandage is placed over the finger if necessary. Fingerprick blood samples will only be collected from participants older than 6 months at 28-32 days after the first home visit (d0). Lancet length will be adjusted for age (2.0 mm for participants 8 years and older, 1.5 mm for participants older than 6 months and younger than 8 years). | Procedure or surgery | Index case and household contacts |
Primary outcome
Mucosal antibodies
Time frame: Day 0
Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid
Mucosal antibodies
Time frame: Day 3 (index cases)
Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid
Mucosal antibodies
Time frame: Day 6 (index cases)
Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid
Mucosal antibodies
Time frame: Day 7 (household contacts)
Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid
Mucosal antibodies
Time frame: Day 14 (household contacts)
Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid
Mucosal antibodies in all participants
Time frame: Day 28
Descriptive analysis of SARS-CoV-2 IgG, IgM and IgA concentrations in nasal fluid
8 secondary outcomes
SARS-CoV-2 infection
Time frame: day 0
Serum antibodies
Time frame: day 28
Functional antibody assays
Time frame: Day 0
Functional antibody assays
Time frame: Day 3 (index cases)
Functional antibody assays
Time frame: Day 6 (index cases)
Functional antibody assays
Time frame: Day 7 (household contacts)
Functional antibody assays
Time frame: Day 14 (household contacts)
Functional antibody assays
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Derived from this study: PubMed 37675756Froberg J, Koomen VJCH, van der Gaast-de Jongh CE, Philipsen R, GeurtsvanKessel CH, de Vries RD, Baas MC, van der Molen RG, de Jonge MI, Hilbrands LB, Huynen MA, Diavatopoulos DA. Primary Exposure to SARS-CoV-2 via Infection or Vaccination Determines Mucosal Antibody-Dependent ACE2 Binding Inhibition. J Infect Dis. 2024 Jan 12;229(1):137-146. doi: 10.1093/infdis/jiad385.
- Individual participant dataSharing planned: No
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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.
Dimitri Diavatopoulos, Dr principal investigator
Radboud University Medical Center
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 SARS-CoV-2 Infection, run by Radboud University Medical Center at 1 site in Netherlands.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 29 Jan 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucosal antibodies (time frame: Day 0). The study lists 6 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 NCT04590352, which also lists 1 linked publication.
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 Jan 2021.