Within Household Transmission of COVID-19 Infections (VERDI)

June 23, 2022 updated by: Patricia Bruijning-Verhagen, UMC Utrecht

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Communty within the region of Utrecht

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Samples and data collected through study completion, an average of 4 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Infer from the data the transmission parameter incubation period.
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.
Infer from the data the transmission parameter generation time.
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.
Infer from the data susceptibility rate of different types of individuals. Calculated as follows: number of secondary cases / total number exposed.
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.
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.
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.
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.
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.
Determine seroconversion rates and how this compares with virologically confirmed SARS-CoV-2 infections
Samples and data collected through study completion, an average of 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Investigators

  • Principal Investigator: Patricia Bruijning, MD PhD, UMC Utrecht

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2022

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

March 17, 2022

First Submitted That Met QC Criteria

June 23, 2022

First Posted (Actual)

June 24, 2022

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 23, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL73581.041.20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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