SARS-CoV-2 InfectionIICov19PRSNCT05074719
Index Individuals in SARS-CoV-2 Prevention Research Studies (COVID-19 Index Individuals Companion Study)
An observational study of SARS-CoV-2 Infection and COVID-19, run by University of Washington at 1 site in United States.
Trial summary
Clinical trials of prevention modalities for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection and coronavirus disease (COVID-19) and pneumonia are underway under separate protocol(s) for close contacts (i.e., household contacts, [e.g.,3502]) of infectious (index) individuals (3502-01). Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- SARS-CoV-2 Infection, COVID-19, Coronavirus Infection
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2020to 31 Oct 2021
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study is enrolling children and adolescents 10 years of age and older and adults 18 and older, identified as the index case(s) of SARS-CoV-2 infection within their households.
Who may be able to join
- Adults 18 and older; children and adolescents 10 years of age and older, at the time of signing the informed assent with parent or guardian consent
- Willing and able to provide informed consent/assent with parental consent
- Diagnosis of SARS-CoV-2 infection using a diagnostic test with a positive result, e.g., RT-PCR, antigen test, or other test format (approved or with Emergency Use Authorization issued by the US FDA or by local health authority) and within the eligibility period of the contact's prevention research study, or is currently being assessed for COVID-19
- A close contact is being screened for enrollment or has enrolled in a SARS-CoV-2 prevention research study
- Access to a smart phone or device with internet access to complete a questionnaire or communicate with research study team
Who cannot join
- Hospitalization (current)
- No household member enrolling/enrolled in a SARS-CoV-2 prevention research study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington International Clinical Research Center
Seattle, Washington, 98104
About this study
Official title: Characterization of the Index Individual for Contact Participants Enrolled in Clinical Trials of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Prevention Interventions; COVID-19 Prevention Trials Network (CoVPN) 3502-01
Clinical trials of prevention modalities for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection and coronavirus disease (COVID-19) and pneumonia are underway under separate protocol(s) for close contacts (i.e., household contacts, [e.g.,3502]) of infectious (index) individuals (3502-01).
Characterizing the index individuals within households will ascertain the risk of exposure for the contact participant. These data will be used to strengthen the precision of efficacy estimates.
Read more
This ancillary observational study will assess the cofactors for infectiousness among index individuals whose close contacts are enrolled in COVID-19 prevention clinical trials.
Additionally, this study will assess post-acute sequelae of SARS-CoV-2 infection in index individuals that are more than two weeks past their initial diagnosis.
Read the detailed description
Within households, the incidence of SARS-CoV-2 is high, but the risk of transmission is characterized by exposure cofactors and transmission mitigation strategies.
Exposure cofactors are defined as cofactors that influence infectiousness of the index individual such as SARS-CoV-2 viral load, SARS-CoV-2 antibodies, and viable virus (as characterized by subgenomic RNA).
Transmission mitigation strategies are defined as modifiable cofactors that influence transmission and currently include physical distancing, social isolation, ventilation, and handwashing.
The continued progression of the pandemic has seen an increase in reports of persistent and/or delayed onset of symptoms and complications in patients well past the acute phase of COVID-19 infection. The prevalence and impacts of these post-acute sequelae of SARS-CoV-2 infection (PASC), which may continue for weeks to months after the initial COVID-19 illness, are not well understood.
Up to approximately 2,000 eligible index individuals who have close contacts (e.g., uninfected household members) in COVID-19 prevention research studies will be invited to participate. Individuals that enroll within two weeks of their diagnosis will be asked to provide a baseline mid-turbinate nasal swab for SARS-CoV-2 testing and complete questionnaires at baseline and on Days 7 and 14. Through these questionnaires, index individuals will report on the clinical course of their illness and share information about their household environment, including potential exposures there-in and any COVID-19 transmission mitigation strategies implemented (whether intentional or as part of standard home routines). Individuals that enroll more than two weeks after being diagnosed will be asked to provide a mid-turbinate nasal swab for SARS-CoV-2 testing and to complete a questionnaire reporting retrospectively on their COVID-19 illness and household environment. These individuals will also complete a questionnaire reporting on the persistence and/or delayed onset of symptoms and complications that they associate with their COVID-19 illness. Enrolled index individuals will also be invited to participate in the SARS-CoV-2 Antibody Sub-study and provide a dried blood spot specimen (at baseline) for antibody testing.
Working closely with prevention research studies, we propose to characterize the index individual level cofactors for SARS-CoV-2 transmission.
Each contact between an index individual and close contact is the unit of analysis for the research study.
The ascertainment of SARS-CoV-2 status among contacts/household members will be done through the parent prevention research study, e.g., through an existing clinical trials agreement with the CoVPN 3502/R 10933-10987-COV-2069 study.h
Across these studies, the investigators aim to assess:
- Prevalence and incidence of SARS-CoV-2 infection in the close contacts.
- Reported SARS-CoV-2 transmission mitigation strategies and exposures as assessed in the index individuals (3502-01) and household contact protocols (e.g., 3502) and the correlation between them.
- Association between the index individual SARS-CoV-2 viral load and subgenomic RNA and infection in the contact participant.
- Association of the duration of symptomatic COVID-19 in the index individual on the risk of SARS-CoV-2 transmission.
- Association of SARS-CoV-2 viral genotype in index individual to related SARS-CoV-2 genotype infection in the contact participant
- Post-acute sequelae of SARS-CoV-2 (PASC) infection in individuals that are weeks to months past their initial SARS-CoV-2 infection.
With these combined household data, effective, modifiable cofactors for household transmission can be identified to inform future post-exposure interventions. With the inclusion of data related to viral and host exposure cofactors, the investigators can increase the precision of predictive models of SARS-CoV-2 infection, adjusted for exposure and mitigation strategies. Data collected on PASC will contribute to the characterization of the long term consequences of SARS-CoV-2 infection and Post-acute COVID-19 Syndrome.
- Conditions
- SARS-CoV-2 Infection, COVID-19, Coronavirus Infection, SARS (Severe Acute Respiratory Syndrome)
- Keywords
- index, cofactors, transmission, prevention, mitigation, viral load, subgenomic RNA, exposure, long COVID, PASC (post-acute sequelae of SARS-CoV-2)
- Medical subject headings
- COVID-19, Coronavirus Infections, Severe Acute Respiratory Syndrome, Erythema Multiforme, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Cohort A comprises individuals that enroll within two weeks of diagnosis of SARS-CoV-2 infection. These individuals will be asked to provide a baseline mid-turbinate nasal swab for SARS-CoV-2 testing and complete questionnaires at baseline and on Days 7 and 14. Through these questionnaires, index individuals will report on the clinical course of their illness and share information about their household environment, including potential exposures there-in and any COVID-19 transmission mitigation strategies implemented (whether intentional or as part of standard home routines). Enrolled Cohort A index individuals will also be invited to participate in the SARS-CoV-2 Antibody Sub-study and provide a dried blood spot specimen (at baseline) for antibody testing. | |
| Cohort B | Cohort B comprises individuals that enroll more than two weeks after diagnosis of SARS-CoV-2 infection. These individuals will be asked to provide a mid-turbinate nasal swab for SARS-CoV-2 testing and to complete a questionnaire reporting retrospectively on their COVID-19 illness and household environment. Through this questionnaire, index individuals will report on the clinical course of their illness and share information about their household environment, including potential exposures there-in and any COVID-19 transmission mitigation strategies implemented (whether intentional or as part of standard home routines). These individuals will also complete a questionnaire reporting on the persistence and/or delayed onset of symptoms and complications that they associate with their COVID-19 illness. Enrolled Cohort B index individuals will also be invited to participate in the SARS-CoV-2 Antibody Sub-study and provide a dried blood spot specimen (at baseline) for antibody testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and incidence of SARS-CoV-2 infection in the household contacts of index individuals
Positive SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) test, or equivalent, as assessed in the Index Individuals Companion Study (3502-01) and household contact COVID-19 Prevention Study (3502) protocols
Measured: Day 1/Baseline for index individuals (3502-01); assessed weekly across 4 weeks for household contacts (3502)
Characterization of reported SARS-CoV-2 transmission mitigation strategies
Characterization and quantification of reported SARS-CoV-2 transmission mitigation strategies as assessed in the index individuals (3502-01) and household contacts (3502) protocols. Assessment of concordance and/or correlation between index individuals' reporting and household contacts' reporting.
Measured: Across 14 days (Day 1/Baseline and Days 7 &14 Questionnaires) for index individuals, or retrospectively for individuals enrolled more than two weeks after diagnosis (3502-01); assessed at baseline and at 4 weeks for household contacts (3502)
Assessment of household exposures
Characterization and quantification of household exposures assessed in the index individuals (3502-01) and household contacts (3502) protocols. Assessment of concordance and/or correlation between index individuals' reporting and household contacts' reporting.
Measured: Across 14 days (Day 1/Baseline and Days 7 &14 Questionnaires) for index individuals, or retrospectively for individuals enrolled more than two weeks after diagnosis (3502-01); assessed at baseline and at 4 weeks for household contacts (3502)
Secondary outcomes (2)
SARS-CoV-2 viral load and/or subgenomic RNA
SARS-CoV-2 semiquantitative RT-PCR and subgenomic RNA from the index individuals' mid-turbinate nasal swab (3502-01)
Measured: Day 1/Baseline sample (single day) for index individuals (3502-01)
SARS-CoV-2 genotyping within households
SARS-CoV-2 genotyping from a subset of index individuals' (3502-01) and household contacts' (3502) mid-turbinate nasal swab samples. Where feasible (per genotype sample availability), genotype comparisons among index and newly infected household (i.e. contacts) members.
Measured: Day 1/Baseline sample (single day) for index individuals; assessed weekly for household contacts, across 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start10 Dec 2020
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Fred Hutchinson Cancer Center
- Responsible party
- Principal investigator, Ruanne Barnabas, University of Washington
- Investigators
- Ruanne Barnabas, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074719
- Sponsor's protocol ID
- STUDY00011462
- Other IDs
- 38771, 3502-01, 3UM1AI068614-14S1
- Acronym
- IICov19PRS
- Status last verified
- Nov 2021
- First submitted
- 8 Oct 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Index Individual for Contact Participants Enrolled in Clinical Trials of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Prevention Interventions; COVID-19 Prevention Trials Network (CoVPN) 3502-01
- ClinicalTrials.gov ID
- NCT05074719
- Acronym / sponsor ID
- IICov19PRS / STUDY00011462
- Conditions
- SARS-CoV-2 Infection, COVID-19, Coronavirus Infection, SARS (Severe Acute Respiratory Syndrome)
- Keywords
- index, cofactors, transmission, prevention, mitigation, viral load, subgenomic RNA, exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Fred Hutchinson Cancer Center
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 12 Oct 2021 (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.
Clinical trials of prevention modalities for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection and coronavirus disease (COVID-19) and pneumonia are underway under separate protocol(s) for close contacts (i.e., household contacts, [e.g.,3502]) of infectious (index) individuals (3502-01).
Characterizing the index individuals within households will ascertain the risk of exposure for the contact participant. These data will be used to strengthen the precision of efficacy estimates.
This ancillary observational study will assess the cofactors for infectiousness among index individuals whose close contacts are enrolled in COVID-19 prevention clinical trials.
Additionally, this study will assess post-acute sequelae of SARS-CoV-2 infection in index individuals that are more than two weeks past their initial diagnosis.
Detailed description
Within households, the incidence of SARS-CoV-2 is high, but the risk of transmission is characterized by exposure cofactors and transmission mitigation strategies.
Exposure cofactors are defined as cofactors that influence infectiousness of the index individual such as SARS-CoV-2 viral load, SARS-CoV-2 antibodies, and viable virus (as characterized by subgenomic RNA).
Transmission mitigation strategies are defined as modifiable cofactors that influence transmission and currently include physical distancing, social isolation, ventilation, and handwashing.
The continued progression of the pandemic has seen an increase in reports of persistent and/or delayed onset of symptoms and complications in patients well past the acute phase of COVID-19 infection. The prevalence and impacts of these post-acute sequelae of SARS-CoV-2 infection (PASC), which may continue for weeks to months after the initial COVID-19 illness, are not well understood.
Up to approximately 2,000 eligible index individuals who have close contacts (e.g., uninfected household members) in COVID-19 prevention research studies will be invited to participate. Individuals that enroll within two weeks of their diagnosis will be asked to provide a baseline mid-turbinate nasal swab for SARS-CoV-2 testing and complete questionnaires at baseline and on Days 7 and 14. Through these questionnaires, index individuals will report on the clinical course of their illness and share information about their household environment, including potential exposures there-in and any COVID-19 transmission mitigation strategies implemented (whether intentional or as part of standard home routines). Individuals that enroll more than two weeks after being diagnosed will be asked to provide a mid-turbinate nasal swab for SARS-CoV-2 testing and to complete a questionnaire reporting retrospectively on their COVID-19 illness and household environment. These individuals will also complete a questionnaire reporting on the persistence and/or delayed onset of symptoms and complications that they associate with their COVID-19 illness. Enrolled index individuals will also be invited to participate in the SARS-CoV-2 Antibody Sub-study and provide a dried blood spot specimen (at baseline) for antibody testing.
Working closely with prevention research studies, we propose to characterize the index individual level cofactors for SARS-CoV-2 transmission.
Each contact between an index individual and close contact is the unit of analysis for the research study.
The ascertainment of SARS-CoV-2 status among contacts/household members will be done through the parent prevention research study, e.g., through an existing clinical trials agreement with the CoVPN 3502/R 10933-10987-COV-2069 study.h
Across these studies, the investigators aim to assess:
- Prevalence and incidence of SARS-CoV-2 infection in the close contacts.
- Reported SARS-CoV-2 transmission mitigation strategies and exposures as assessed in the index individuals (3502-01) and household contact protocols (e.g., 3502) and the correlation between them.
- Association between the index individual SARS-CoV-2 viral load and subgenomic RNA and infection in the contact participant.
- Association of the duration of symptomatic COVID-19 in the index individual on the risk of SARS-CoV-2 transmission.
- Association of SARS-CoV-2 viral genotype in index individual to related SARS-CoV-2 genotype infection in the contact participant
- Post-acute sequelae of SARS-CoV-2 (PASC) infection in individuals that are weeks to months past their initial SARS-CoV-2 infection.
With these combined household data, effective, modifiable cofactors for household transmission can be identified to inform future post-exposure interventions. With the inclusion of data related to viral and host exposure cofactors, the investigators can increase the precision of predictive models of SARS-CoV-2 infection, adjusted for exposure and mitigation strategies. Data collected on PASC will contribute to the characterization of the long term consequences of SARS-CoV-2 infection and Post-acute COVID-19 Syndrome.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | –Cohort A comprises individuals that enroll within two weeks of diagnosis of SARS-CoV-2 infection. These individuals will be asked to provide a baseline mid-turbinate nasal swab for SARS-CoV-2 testing and complete questionnaires at baseline and on Days 7 and 14. Through these questionnaires, index individuals will report on the clinical course of their illness and share information about their household environment, including potential exposures there-in and any COVID-19 transmission mitigation strategies implemented (whether intentional or as part of standard home routines). Enrolled Cohort A index individuals will also be invited to participate in the SARS-CoV-2 Antibody Sub-study and provide a dried blood spot specimen (at baseline) for antibody testing. |
| Cohort B | – | –Cohort B comprises individuals that enroll more than two weeks after diagnosis of SARS-CoV-2 infection. These individuals will be asked to provide a mid-turbinate nasal swab for SARS-CoV-2 testing and to complete a questionnaire reporting retrospectively on their COVID-19 illness and household environment. Through this questionnaire, index individuals will report on the clinical course of their illness and share information about their household environment, including potential exposures there-in and any COVID-19 transmission mitigation strategies implemented (whether intentional or as part of standard home routines). These individuals will also complete a questionnaire reporting on the persistence and/or delayed onset of symptoms and complications that they associate with their COVID-19 illness. Enrolled Cohort B index individuals will also be invited to participate in the SARS-CoV-2 Antibody Sub-study and provide a dried blood spot specimen (at baseline) for antibody testing. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study is enrolling children and adolescents 10 years of age and older and adults 18 and older, identified as the index case(s) of SARS-CoV-2 infection within their households.
Key inclusion criteria (5 listed)
- Adults 18 and older; children and adolescents 10 years of age and older, at the time of signing the informed assent with parent or guardian consent
- Willing and able to provide informed consent/assent with parental consent
- Diagnosis of SARS-CoV-2 infection using a diagnostic test with a positive result, e.g., RT-PCR, antigen test, or other test format (approved or with Emergency Use Authorization issued by the US FDA or by local health authority) and within the eligibility period of the contact's prevention research study, or is currently being assessed for COVID-19
- A close contact is being screened for enrollment or has enrolled in a SARS-CoV-2 prevention research study
- Access to a smart phone or device with internet access to complete a questionnaire or communicate with research study team
Key exclusion criteria (2 listed)
- Hospitalization (current)
- No household member enrolling/enrolled in a SARS-CoV-2 prevention research study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence and incidence of SARS-CoV-2 infection in the household contacts of index individuals
Time frame: Day 1/Baseline for index individuals (3502-01); assessed weekly across 4 weeks for household contacts (3502)
Positive SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) test, or equivalent, as assessed in the Index Individuals Companion Study (3502-01) and household contact COVID-19 Prevention Study (3502) protocols
Characterization of reported SARS-CoV-2 transmission mitigation strategies
Time frame: Across 14 days (Day 1/Baseline and Days 7 &14 Questionnaires) for index individuals, or retrospectively for individuals enrolled more than two weeks after diagnosis (3502-01); assessed at baseline and at 4 weeks for household contacts (3502)
Characterization and quantification of reported SARS-CoV-2 transmission mitigation strategies as assessed in the index individuals (3502-01) and household contacts (3502) protocols. Assessment of concordance and/or correlation between index individuals' reporting and household contacts' reporting.
Assessment of household exposures
Time frame: Across 14 days (Day 1/Baseline and Days 7 &14 Questionnaires) for index individuals, or retrospectively for individuals enrolled more than two weeks after diagnosis (3502-01); assessed at baseline and at 4 weeks for household contacts (3502)
Characterization and quantification of household exposures assessed in the index individuals (3502-01) and household contacts (3502) protocols. Assessment of concordance and/or correlation between index individuals' reporting and household contacts' reporting.
2 secondary outcomes
SARS-CoV-2 viral load and/or subgenomic RNA
Time frame: Day 1/Baseline sample (single day) for index individuals (3502-01)
SARS-CoV-2 genotyping within households
Time frame: Day 1/Baseline sample (single day) for index individuals; assessed weekly for household contacts, across 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 15 Dec 2021.
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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.
Ruanne Barnabas, MD principal investigator
University of Washington
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 and COVID-19, run by University of Washington at 1 site in United States.
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 5 inclusion and 2 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 15 Dec 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 United States. 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?
Prevalence and incidence of SARS-CoV-2 infection in the household contacts of index individuals (time frame: Day 1/Baseline for index individuals (3502-01); assessed weekly across 4 weeks for household contacts (3502)). The study lists 3 primary outcomes in all. 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 15 Dec 2021.