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

NCT05074719 | Completed

• 4 other identifiers: STUDY00011462387713502-013UM1AI068614-14S1
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  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

  Day 1/Baseline sample (single day) for index individuals (3502-01)

• SARS-CoV-2 genotyping within households

  Day 1/Baseline sample (single day) for index individuals; assessed weekly for household contacts, across 4 weeks.

Other Outcomes (1)

• Serum-based antibodies to SARS-CoV-2

  An optional, Day 1/Baseline sample (single day) for index individuals (3502-01).

Study Arms (2)

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.

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Fred Hutchinson Cancer Center: collaborator

Study Sites (1)

University of Washington International Clinical Research Center

Seattle, Washington, 98104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

1\) mid-turbinate nasal swab sample and 2) dried blood spot sample (optional)

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Severe Acute Respiratory Syndrome; Erythema Multiforme; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Erythema; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vesiculobullous; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ruanne Barnabas, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine: Global Health

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 12, 2021
• Study Start: December 10, 2020
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: December 15, 2021

Record last verified: 2021-11

Locations

US (1)