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Index Individuals in SARS-CoV-2 Prevention Research Studies (COVID-19 Index Individuals Companion Study) (IICov19PRS)

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ClinicalTrials.gov Identifier: NCT05074719
Recruitment Status : Active, not recruiting
First Posted : October 12, 2021
Last Update Posted : November 16, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Fred Hutchinson Cancer Research Center
Information provided by (Responsible Party):
Ruanne Barnabas, University of Washington

Brief 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).

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.


Condition or disease
SARS-CoV-2 Infection COVID-19 Coronavirus Infection SARS (Severe Acute Respiratory Syndrome)

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Study Type : Observational
Actual Enrollment : 155 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : December 10, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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 semiquantitative RT-PCR and subgenomic RNA from the index individuals' mid-turbinate nasal swab (3502-01)

  2. 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. ]
    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.


Other Outcome Measures:
  1. Serum-based antibodies to SARS-CoV-2 [ Time Frame: An optional, Day 1/Baseline sample (single day) for index individuals (3502-01). ]
    Measurement of antibodies to SARS-CoV-2 in index individuals (3502-01) and household contacts (3502) based on dried blood spot sample(s).


Biospecimen Retention:   Samples With DNA
1) mid-turbinate nasal swab sample and 2) dried blood spot sample (optional)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  1. 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
  2. Willing and able to provide informed consent/assent with parental consent
  3. 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
  4. A close contact is being screened for enrollment or has enrolled in a SARS-CoV-2 prevention research study
  5. Access to a smart phone or device with internet access to complete a questionnaire or communicate with research study team

Exclusion Criteria:

  1. Hospitalization (current)
  2. No household member enrolling/enrolled in a SARS-CoV-2 prevention research study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05074719


Locations
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United States, Washington
University of Washington International Clinical Research Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
National Institutes of Health (NIH)
Fred Hutchinson Cancer Research Center
Investigators
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Principal Investigator: Ruanne Barnabas, MD University of Washington
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Responsible Party: Ruanne Barnabas, Associate Professor, School of Medicine: Global Health, University of Washington
ClinicalTrials.gov Identifier: NCT05074719    
Other Study ID Numbers: STUDY00011462
38771 ( Registry Identifier: DAIDS, NIAID, NIH )
3502-01 ( Other Grant/Funding Number: COVID-19 Prevention Network (CoVPN) )
First Posted: October 12, 2021    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ruanne Barnabas, University of Washington:
index
cofactors
transmission
prevention
mitigation
viral load
subgenomic RNA
exposure
long COVID
PASC (post-acute sequelae of SARS-CoV-2)
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Coronavirus Infections
Severe Acute Respiratory Syndrome
Syndrome
Disease
Pathologic Processes
Disease Attributes
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases