SARS-CoV-2VERDINCT05430516
Within Household Transmission of COVID-19 Infections
An observational study of SARS-CoV-2, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
In the absence of a vaccine, the spread of SARS-CoV-2 can only be mitigated via non-pharmaceutical interventions that reduce the risks of forward transmission. Currently, European policymakers are implementing combinations of fierce pandemic control measures. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- How many people
- 450 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Jan 2022to 1 May 2022
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Communty within the region of Utrecht
Who may be able to join
- All members of the household or their legal guardians consent to participation
- All members of the household are willing to complete diaries and questionnaires for the duration of follow-up
- All members of the household are willing to, and capable of self-sampling nose-throat swabs, (a subset) saliva and capillary blood samples by finger. If parents/caretakers of young children are reluctant to take a blood sample from their child, this is no reason for exclusion.
Who cannot join
- Patients or household members who are unable to consent, or do not wish to provide informed consent.
- Children, pregnant women and patients lacking capacity will be included. Those lacking capacity to consent for themselves will be identified and consent will be sought from an appropriate consulted.
- Households who do not have daily access to a smartphone or tablet with internet connection, will be excluded, as follow-up of households requires the use of an interactive diary App.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Within Household Transmission of SARS-CoV-2 Infections, a Multicentre Prospective
In the absence of a vaccine, the spread of SARS-CoV-2 can only be mitigated via non-pharmaceutical interventions that reduce the risks of forward transmission. Currently, European policymakers are implementing combinations of fierce pandemic control measures. However, there is substantial uncertainty on the transmission dynamics of SARS-CoV-2 and, consequently, the effect of each specific mitigation intervention as well as their joint impact on the pandemic evolution. Moreover, it is uncertain how and when the Public Health response should be modified once the pandemic starts to slow. There is an urgent need for data that can help to further unravel the key transmission characteristics of SARS-CoV-2 in the population. Household studies are, therefore, a useful approach to obtain insight into the main determinants of transmission and to derive estimates of transmission parameters. By fully characterizing the critical process of SARS-CoV-2 household transmission and how they vary by patient and household characteristics, infection dynamics in the population can be further elucidated.
Responding to SARS-CoV-2 effectively from a community care perspective will also require understanding the perceptions, beliefs, and actions taken by patients and the public.
Read more
A 'bottom-up' understating of such issues is critical to understand how best to design effective community strategies.
Rapid European COVID-19 Emergency Research response (RECOVER) is a project involving ten international partners that have been selected for funding by the European Union under the Horizon 2020 research framework. RECOVER responds to call topic SC1-PHE-CORONAVIRUS-2020: Advancing knowledge for the clinical and public health response to the SARS-CoV-2 epidemic and builds on many years of investment by the European Commission in clinical research preparedness for epidemic response. RECOVER will therefore provide a range of data and analytical results to guide the Public Health response, including the here described household transmission study.
Objective: Estimate key transmission parameters of SARS-CoV-2 in Europe from observing within household virus spread and seroconversion of household members and characterize the views and experiences of households regarding perceptions, practices regarding infection control, and impacts of imposed isolation measures.
- Conditions
- SARS-CoV-2
- Being tested
- No intervention
- Keywords
- SARS-CoV-2, Omicron, Children, Household study, Tranmission
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Families | Patients with confirmed SARS-Cov-2 infection and their household members of all ages can be enrolled in the study, if at least one household member is a child age under 18. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate key transmission parameters of SARS-CoV-2 in Europe from observing within household virus spread and seroconversion of household members through study completion, an average of 4 weeks.
Estimate key transmission parameters of SARS-CoV-2 in Europe from observing within household virus spread and seroconversion of household members. Including secondary attack rates and Transmission rate.
Measured: Samples and data collected through study completion, an average of 4 weeks.
Secondary outcomes (6)
Estimate the incubation period through study completion, an average of 4 weeks.
Infer from the data the transmission parameter incubation period.
Measured: Samples and data collected through study completion, an average of 4 weeks.
Estimate the generation time through study completion, an average of 4 weeks.
Infer from the data the transmission parameter generation time.
Measured: Samples and data collected through study completion, an average of 4 weeks.
Estimate the susceptibility through study completion, an average of 4 weeks.
Infer from the data susceptibility rate of different types of individuals. Calculated as follows: number of secondary cases / total number exposed.
Measured: Samples and data collected through study completion, an average of 4 weeks.
Estimate the infectiousness through study completion, an average of 4 weeks.
Infer from the data infectiousness rate of different types of individuals. Calculated as follows: number of index cases with secondary transmission / total number of index cases.
Measured: Samples and data collected through study completion, an average of 4 weeks.
Estimate the transmission through study completion, an average of 4 weeks.
Infer from the data the transmission rate of different types of households (e.g. number of household members, living conditions, sanitary facilities, pets) and behavioral characteristics.
Measured: Samples and data collected through study completion, an average of 4 weeks.
Determine seroconversion rates and how this compares with virologically confirmed SARS-CoV-2 infections through study completion, an average of 4 weeks.
Determine seroconversion rates and how this compares with virologically confirmed SARS-CoV-2 infections
Measured: Samples and data collected through study completion, an average of 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start15 Jan 2022
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Bruijning-Verhagen, UMC Utrecht
- Investigators
- Patricia Bruijning, MD PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430516
- Sponsor's protocol ID
- NL73581.041.20
- Acronym
- VERDI
- Status last verified
- Jun 2022
- First submitted
- 17 Mar 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Within Household Transmission of SARS-CoV-2 Infections, a Multicentre Prospective
- ClinicalTrials.gov ID
- NCT05430516
- Acronym / sponsor ID
- VERDI / NL73581.041.20
- Conditions
- SARS-CoV-2
- Keywords
- SARS-CoV-2, Omicron, Children, Household study, Tranmission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 24 Jun 2022 (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 the absence of a vaccine, the spread of SARS-CoV-2 can only be mitigated via non-pharmaceutical interventions that reduce the risks of forward transmission. Currently, European policymakers are implementing combinations of fierce pandemic control measures. However, there is substantial uncertainty on the transmission dynamics of SARS-CoV-2 and, consequently, the effect of each specific mitigation intervention as well as their joint impact on the pandemic evolution. Moreover, it is uncertain how and when the Public Health response should be modified once the pandemic starts to slow. There is an urgent need for data that can help to further unravel the key transmission characteristics of SARS-CoV-2 in the population. Household studies are, therefore, a useful approach to obtain insight into the main determinants of transmission and to derive estimates of transmission parameters. By fully characterizing the critical process of SARS-CoV-2 household transmission and how they vary by patient and household characteristics, infection dynamics in the population can be further elucidated.
Responding to SARS-CoV-2 effectively from a community care perspective will also require understanding the perceptions, beliefs, and actions taken by patients and the public.
A 'bottom-up' understating of such issues is critical to understand how best to design effective community strategies.
Rapid European COVID-19 Emergency Research response (RECOVER) is a project involving ten international partners that have been selected for funding by the European Union under the Horizon 2020 research framework. RECOVER responds to call topic SC1-PHE-CORONAVIRUS-2020: Advancing knowledge for the clinical and public health response to the SARS-CoV-2 epidemic and builds on many years of investment by the European Commission in clinical research preparedness for epidemic response. RECOVER will therefore provide a range of data and analytical results to guide the Public Health response, including the here described household transmission study.
Objective: Estimate key transmission parameters of SARS-CoV-2 in Europe from observing within household virus spread and seroconversion of household members and characterize the views and experiences of households regarding perceptions, practices regarding infection control, and impacts of imposed isolation measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Families | – | Other: No interventionPatients with confirmed SARS-Cov-2 infection and their household members of all ages can be enrolled in the study, if at least one household member is a child age under 18. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Communty within the region of Utrecht
Key inclusion criteria (3 listed)
- All members of the household or their legal guardians consent to participation
- All members of the household are willing to complete diaries and questionnaires for the duration of follow-up
- All members of the household are willing to, and capable of self-sampling nose-throat swabs, (a subset) saliva and capillary blood samples by finger. If parents/caretakers of young children are reluctant to take a blood sample from their child, this is no reason for exclusion.
Key exclusion criteria (3 listed)
- Patients or household members who are unable to consent, or do not wish to provide informed consent.
- Children, pregnant women and patients lacking capacity will be included. Those lacking capacity to consent for themselves will be identified and consent will be sought from an appropriate consulted.
- Households who do not have daily access to a smartphone or tablet with internet connection, will be excluded, as follow-up of households requires the use of an interactive diary App.
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 |
|---|---|---|
| No interventionNo intervention | Other | Families |
Primary outcome
Estimate key transmission parameters of SARS-CoV-2 in Europe from observing within household virus spread and seroconversion of household members through study completion, an average of 4 weeks.
Time frame: Samples and data collected through study completion, an average of 4 weeks.
Estimate key transmission parameters of SARS-CoV-2 in Europe from observing within household virus spread and seroconversion of household members. Including secondary attack rates and Transmission rate.
6 secondary outcomes
Estimate the incubation period through study completion, an average of 4 weeks.
Time frame: Samples and data collected through study completion, an average of 4 weeks.
Estimate the generation time through study completion, an average of 4 weeks.
Time frame: Samples and data collected through study completion, an average of 4 weeks.
Estimate the susceptibility through study completion, an average of 4 weeks.
Time frame: Samples and data collected through study completion, an average of 4 weeks.
Estimate the infectiousness through study completion, an average of 4 weeks.
Time frame: Samples and data collected through study completion, an average of 4 weeks.
Estimate the transmission through study completion, an average of 4 weeks.
Time frame: Samples and data collected through study completion, an average of 4 weeks.
Determine seroconversion rates and how this compares with virologically confirmed SARS-CoV-2 infections through study completion, an average of 4 weeks.
Time frame: Samples and data collected through study completion, an average of 4 weeks.
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 24 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
Patricia Bruijning, MD PhD principal investigator
UMC Utrecht
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, run by UMC Utrecht 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 3 inclusion and 3 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 24 Jun 2022. 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?
Estimate key transmission parameters of SARS-CoV-2 in Europe from observing within household virus spread and seroconversion of household members through study completion, an average of 4 weeks. (time frame: Samples and data collected through study completion, an average of 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2022.