Coronavirus Disease 2019 (COVID-19)HEROSNCT04375761

COVID-19: Human Epidemiology and Response to SARS-CoV-2

An observational study of Coronavirus Disease 2019 (COVID-19) and SARS-CoV-2, run by National Institute of Allergy and Infectious Diseases (NIAID) at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The human disease caused by SARS-CoV-2 is called COVID-19. In most cases, COVID-19 presents as a mild to moderate respiratory illness. But it can also be more severe and even lead to death. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Coronavirus Disease 2019 (COVID-19), SARS-CoV-2
What is being tested?: Collection of Biological Samples and Symptom and Exposure Surveys
Type of treatment: Surgery or procedure
How many people: 5,599 participants
Where: 20 sitesUnited States
Study dates: 1 May 2020to 29 Mar 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: NIH-funded study participants (index participants) and their families This includes participants who have asthma and/or other atopic or allergic conditions, as well as healthy index participants, all with extensive medical information and information on atopic and allergic status available as a result of their participation in an NIH-funded study. As many of these are birth cohort studies, there is extensive information available on the parents. The majority of the families have experience with collection of respiratory samples and completing respiratory questionnaires.

Who may be able to join

Household members who meet all of the following criteria are eligible for enrollment as study participants:
The index participant, defined as an individual who either is or has been a participant in an NIH-funded clinical research study from which information on respiratory conditions, including asthma, and other atopic and allergic diseases is available, is:
≤21 years of age, and
Lives with caregiver(s).
The index participant and/or caregiver understands the study procedures and is willing to conduct these procedures at home;
Have the ability to use either a computer or a smart phone to link to and respond to the study questionnaires:

Show all 13Show fewer

--Exception: When the family is willing to speak with a study member to answer the questionnaires in the event of not having access to a computer or a smart phone.
The index participant and caregiver will reside in the United States, including Puerto Rico, for the duration of the study;
The index participant will live with the caregiver for at least 50% of the time for the duration of the study;
An English or Spanish speaker is available to:
Serve as the primary contact, and
As the person who will be responsible for the completion of questionnaires and the collection of study biological samples; and,
To participate as a sibling (of the index participant), must be under 21 years of age and live in the same home as the index participant and caregiver.

Who cannot join

-Past or current medical problems, which, in the opinion of the site investigator may:
Pose risks from participation in the study
Interfere with the participant's ability to comply with study requirements, or
Impact the quality or interpretation of the data obtained from the study.

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Children's Hospital Colorado: Inner City Asthma Consortium (ICAC) Site
Aurora, Colorado, 80045
Children's Hospital Colorado: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages (OMEGA) Site
Aurora, Colorado, 80045
Massachusetts General Hospital:Childhood Microbiome (CHIME) and Wheezing Index (WIND) Site
Boston, Massachusetts, 02114
Boston Children's Hospital: School Inner-City Asthma Study (SICAS-2), Environmental Assessment of Sleep in Youth (EASY), Severe Asthma Research Program (SARP) and Preventing Asthma in High Risk Kids (PARK) Site
Boston, Massachusetts, 02115
Boston Medical Center: Inner City Asthma Consortium (ICAC) Site
Boston, Massachusetts, 02118
Ann & Robert H. Lurie Children's Hospital of Chicago: Food Allergy Outcomes Related to White and African American Racial Differences (FORWARD) and Improving Technology-Assisted Recording of Asthma Control in Children (iTRACC) Site
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center: Greater Cincinnati Pediatric Clinic Repository (GCPCR) and Mechanisms of Progression of Atopic Dermatitis to Asthma in Children (MPAACH) Site
Cincinnati, Ohio, 45229
Cincinnati Children's Hospital Medical Center: Inner City Asthma Consortium (ICAC) Site
Cincinnati, Ohio, 45229
Cincinnati Children's Hospital Medical Center: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages (OMEGA) Site
Cincinnati, Ohio, 45229
Cincinnati Children's Hospital Medical Center:Cincinnati Childhood Allergy & Air Pollution Study (CCAAPS) Site
Cincinnati, Ohio, 45229
University of Texas Southwestern Medical Center: Inner City Asthma Consortium (ICAC) Site
Dallas, Texas, 75390
Henry Ford Health System: Childhood Allergy Study (CAS) Site
Detroit, Michigan, 48202
Henry Ford Health System: Inner City Asthma Consortium (ICAC) Site
Detroit, Michigan, 48202
Henry Ford Health System: Microbes, Asthma, Allergy and Pets (MAAP) and Wayne County Health, Environment, Allergy, and Asthma Longitudinal Study (WHEALS) Site
Detroit, Michigan, 48202
University of Wisconsin Hospital and Clinics: Childhood Origins of Asthma (COAST) Site
Madison, Wisconsin, 53792
University of Wisconsin Hospital and Clinics: Wisconsin Infant Study Cohort (WISC) Site
Madison, Wisconsin, 53792
Vanderbilt University Medical Center: Infant Susceptibility to Pulmonary Infections and Asthma Following RSV Exposure Study (INSPIRE) Site
Nashville, Tennessee, 37232
Columbia University Medical Center: Inner City Asthma Consortium (ICAC) Site
New York, New York, 10032
St. Louis Children's Hospital: Inner City Asthma Consortium (ICAC) Site
St Louis, Missouri, 63110
Children's National Medical Center: Inner City Asthma Consortium (ICAC) Site
Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: Human Epidemiology and Response to SARS-CoV-2 (DAIT-COVID-19-001)

The human disease caused by SARS-CoV-2 is called COVID-19. In most cases, COVID-19 presents as a mild to moderate respiratory illness. But it can also be more severe and even lead to death.

The purpose of this study is to:

Determine the prevalence of SARS-CoV-2 carrier status over time in children and parents
Determine the prevalence of antibody development over time in children and parents
Compare carrier status and antibody development for children with asthma and/or other atopic conditions (e.g. eczema) versus children without asthma and/or other atopic conditions
Investigate the presence of SARS-CoV-2 exposure in historical samples from enrolled participants

Read the detailed description

The study population will include children that are participants in NIH-funded cohort studies and their families (household contacts).The intent is to recruit families that have experience with the collection of respiratory samples.

The objective of this surveillance study is to identify the rate of infection in children and what, if any effect, atopy has on the SARS-CoV-2 carrier status.

The initial surveillance interval for participants will be 6 months and, depending upon the findings, may be extended. During surveillance, biological samples will be collected by the family at established intervals and symptom and exposure surveys will be completed remotely via a smart phone, on-line, or phone communications at the time the biological samples are collected.

Conditions: Coronavirus Disease 2019 (COVID-19), SARS-CoV-2
Being tested: Collection of Biological Samples, Symptom and Exposure Surveys
Keywords: COVID-19, SARS-CoV-2, Public Health Surveillance, Participants in NIH-funded studies (and their families)
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Collection of Biological SamplesProcedure or surgery
Biological samples will be collected throughout the study at regular intervals (every 2 weeks) in addition to when illness event(s) occur. All biological samples (e.g. nasal swabs, peripheral blood, stool) will be collected by the caregiver at home using materials provided to the family. At the end of study, additional samples (e.g. nasal secretion and/or saliva samples) may be collected by the family or study staff at a site visit, if feasible.
Symptom and Exposure SurveysProcedure or surgery
Also called Symptom and Exposure Questionnaires
Symptom and exposure surveys (questionnaires) will be completed throughout the study at regular intervals (every 2 weeks) in addition to when illness event(s) occur. The primary household contact/caregiver will be the designee for ensuring timely questionnaires completion and submission for all household study participants.

Study groups in NCT04375761
Study group	Role	What they receive
SARS-CoV-2 Surveillance: Total Group		Participants either currently or in the past, enrolled in National Institutes of Health (NIH)-funded cohort studies, and their families (household contacts). Active surveillance for detection of SARS-CoV-2 for 6 months, beginning with enrollment. During surveillance, biological samples will be collected by the family at established intervals and symptom and exposure surveys will be completed at the time that biological samples are collected. Receives: Procedure: Collection of Biological Samples; Procedure: Symptom and Exposure Surveys

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period
Nasal samples were analyzed to determine whether a participant ever tested positive for SARS-CoV-2 or not over the course of the study. Kaplan-Meier was used to estimate survival probabilities at timepoints throughout the study. Participants were censored if they did not test positive for SARS-CoV-2 by the end of follow-up. The last positive nasal swab occurred at day 212.
Measured: Baseline through end of study (24 or 28 weeks, depending on if a participant agreed to do the extension)

Secondary outcomes (9)

Percent of Index Participants and Their Household Contacts With Detectable SARS-CoV-2-Specific Antibodies in Serum Over the Study/Surveillance Period
Included: Participants currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria (index participant) and their family/household contacts.
Outcome definition: Detectable SARS-CoV-2-specific antibodies in serum biological specimen(s).
Measured: Up to Week 24
Number of Index Participants With SARS-CoV-2 Detection in Nasal Samples With Asthma and Other Atopic Disease Compared to Index Participants Without Atopic Disease Over the Study/Surveillance Period
Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria.
Testing method: Positive test result(s) for SARS-CoV-2 RNA in nasal samples.
Measured: Up to Week 24
Percent of Index Participants With Asthma and Other Atopic Disease With Detectable SARS-CoV-2-Specific Antibodies in Serum Compared to Index Participants Without Atopic Disease Over the Study/Surveillance Period
Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria.
Outcome definition: Detectable SARS-CoV-2-specific antibodies in serum biological specimen(s).
Measured: Through study completion, an average of 24 Weeks
Changes in the Nasal Transcriptome Associated With Detection of SARS-CoV-2 in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period
Nasal samples of participants currently or previously enrolled in NIH-funded studies who fulfill inclusion criteria (index participant) and their family/household contacts that test positive for SARS-CoV-2, will undergo transcriptome analysis.
Total RNA will be isolated for cDNA synthesis and amplification. Differential gene expression analysis be pursued.
Measured: Up to Week 24
Changes in the Nasal Transcriptome Associated With Detection of SARS-CoV-2 in Nasal Samples Among Index Participants With Asthma and Other Atopic Disease Compared to Index Participants Without Atopic Disease Over the Study/Surveillance Period
Nasal samples of index participants that test positive for SARS-CoV-2 will be evaluated by transcriptome analysis. Differential gene expression analysis at different timepoints in the disease process will be analyzed.
Definition of index participant(s): Prior and/or current NIH-funded clinical research study participant(s) who fulfill inclusion criteria.
Measured: Up to Week 24
Symptoms Associated With Detection of SARS-CoV-2 in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period
An analysis of symptoms associated with positive SARS-CoV-2 RNA tests in nasal samples will be conducted.
Included in analysis: Index participants and their household contacts.
Measured: Up to Week 24
Number of Index Participants With SARS-CoV-2 Detection in Nasal Samples Using Topical Steroids Compared to Index Participants That Are Not Using Topical Steroids Over the Study/Surveillance Period
Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria.
Tests: Positive for SARS-CoV-2 RNA in nasal samples
Measured: Up to Week 24
Number of Index Participants With SARS-CoV-2 Detection in Nasal Samples Using Topical, Oral, or Inhaled Steroids Compared to Index Participants That Are Not Using Topical, Oral, or Inhaled Steroids During the Study/Surveillance Period
Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria.
Tests: Positive for SARS-CoV-2 RNA in nasal samples.
Measured: Up to Week 24
Analysis of Factors, Baseline and Prior History, for Possible Association With the Cumulative Incidence of SARS-COV-2 Detection in Nasal Samples: Index Participants and Their Household Contacts Over the Study/Surveillance Period
An exploratory analysis will be conducted for detection of possible associations, focusing on baseline demographic and environment factors and/or history of bronchiolitis prior history with the cumulative incidence of SARS-CoV-2 detection in nasal samples Test: Positive for SARS-CoV-2 RNA in nasal samples.
Measured: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202029 Mar 2021

First posted5 May 2020
Study start1 May 2020
Primary completion29 Mar 2021
Study completion29 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Coronavirus Disease 2019 (COVID-19)Studies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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: Family based
Time perspective: Prospective
Enrolment: 5,599 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04375761
Sponsor's protocol ID: DAIT-COVID-19-001
Acronym: HEROS
Status last verified: Jul 2025
First submitted: 30 Apr 2020
Last updated: 6 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Moore CM, Secor EA, Everman JL, Fairbanks-Mahnke A, Jackson N, Pruesse E, Diener K, Morin A, Arbes SJ, Bacharier LB, Bendixsen CG, Calatroni A, Dupont WD, Furuta GT, Gebretsadik T, Gruchalla RS, Gupta RS, Khurana Hershey GK, Kattan M, Liu AH, Lussier SJ, Murrison LB, Numata M, O'Connor GT, Rivera-Spoljaric K, Phipatanakul W, Rothenberg ME, Seroogy CM, Zoratti EM, Castina S, Jackson DJ, Camargo CA Jr, Johnson CC, Ethridge R, Ramratnam S, Stelzig L, Teach SJ, Togias AG, Fulkerson PC, Hartert TV, Seibold MA. The Common Cold Is Associated With Protection From SARS-CoV-2 Infections. J Infect Dis. 2025 Dec 20;232(6):e920-e930. doi: 10.1093/infdis/jiaf374.
PubMed 40795882
Fulkerson PC, Lussier SJ, Bendixsen CG, Castina SM, Gebretsadik T, Marlin JS, Russell PB, Seibold MA, Everman JL, Moore CM, Snyder BM, Thompson K, Tregoning GS, Wellford S, Arbes SJ, Bacharier LB, Calatroni A, Camargo CA Jr, Dupont WD, Furuta GT, Gruchalla RS, Gupta RS, Hershey GK, Jackson DJ, Johnson CC, Kattan M, Liu AH, Murrison L, O'Connor GT, Phipatanakul W, Rivera-Spoljaric K, Rothenberg ME, Seroogy CM, Teach SJ, Zoratti EM, Togias A, Hartert TV, Heros Study Team OBOT. Human Epidemiology and Response to SARS-CoV-2 (HEROS): objectives, design, and enrollment results of a 12-city remote observational surveillance study of households with children, using direct-to-participant methods. Am J Epidemiol. 2024 Oct 7;193(10):1329-1338. doi: 10.1093/aje/kwae077.
PubMed 38775275

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Human Epidemiology and Response to SARS-CoV-2 (DAIT-COVID-19-001)
ClinicalTrials.gov ID: NCT04375761
Acronym / sponsor ID: HEROS / DAIT-COVID-19-001
Conditions: Coronavirus Disease 2019 (COVID-19), SARS-CoV-2
Keywords: COVID-19, SARS-CoV-2, Public Health Surveillance, Participants in NIH-funded studies (and their families)
Study type: Observational
Recruitment status: Completed
Enrolment: 5,599 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Collaborators: Rho Federal Systems Division, Inc.
Study start: 1 May 2020 (actual)
Primary completion: 29 Mar 2021 (actual)
Study completion: 29 Mar 2021 (actual)
First posted: 5 May 2020 (actual)
Results: Posted 5 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The human disease caused by SARS-CoV-2 is called COVID-19. In most cases, COVID-19 presents as a mild to moderate respiratory illness. But it can also be more severe and even lead to death.

The purpose of this study is to:

Determine the prevalence of SARS-CoV-2 carrier status over time in children and parents
Determine the prevalence of antibody development over time in children and parents
Compare carrier status and antibody development for children with asthma and/or other atopic conditions (e.g. eczema) versus children without asthma and/or other atopic conditions
Investigate the presence of SARS-CoV-2 exposure in historical samples from enrolled participants

Detailed description

The objective of this surveillance study is to identify the rate of infection in children and what, if any effect, atopy has on the SARS-CoV-2 carrier status.

Study design

Observational model: Family based
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
SARS-CoV-2 Surveillance: Total Group	–	Procedure: Collection of Biological Samples, Procedure: Symptom and Exposure SurveysParticipants either currently or in the past, enrolled in National Institutes of Health (NIH)-funded cohort studies, and their families (household contacts). Active surveillance for detection of SARS-CoV-2 for 6 months, beginning with enrollment. During surveillance, biological samples will be collected by the family at established intervals and symptom and exposure surveys will be completed at the time that biological samples are collected.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: NIH-funded study participants (index participants) and their families This includes participants who have asthma and/or other atopic or allergic conditions, as well as healthy index participants, all with extensive medical information and information on atopic and allergic status available as a result of their participation in an NIH-funded study. As many of these are birth cohort studies, there is extensive information available on the parents. The majority of the families have experience with collection of respiratory samples and completing respiratory questionnaires.

Key inclusion criteria (13 listed)

Household members who meet all of the following criteria are eligible for enrollment as study participants:
The index participant, defined as an individual who either is or has been a participant in an NIH-funded clinical research study from which information on respiratory conditions, including asthma, and other atopic and allergic diseases is available, is:
The index participant and/or caregiver understands the study procedures and is willing to conduct these procedures at home;
Have the ability to use either a computer or a smart phone to link to and respond to the study questionnaires:
--Exception: When the family is willing to speak with a study member to answer the questionnaires in the event of not having access to a computer or a smart phone.

Key exclusion criteria (4 listed)

Pose risks from participation in the study
Interfere with the participant's ability to comply with study requirements, or
Impact the quality or interpretation of the data obtained from the study.

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
Collection of Biological SamplesBiological samples will be collected throughout the study at regular intervals (every 2 weeks) in addition to when illness event(s) occur. All biological samples (e.g. nasal swabs, peripheral blood, stool) will be collected by the caregiver at home using materials provided to the family. At the end of study, additional samples (e.g. nasal secretion and/or saliva samples) may be collected by the family or study staff at a site visit, if feasible.	Procedure or surgery	SARS-CoV-2 Surveillance: Total Group
Symptom and Exposure SurveysAlso: Symptom and Exposure QuestionnairesSymptom and exposure surveys (questionnaires) will be completed throughout the study at regular intervals (every 2 weeks) in addition to when illness event(s) occur. The primary household contact/caregiver will be the designee for ensuring timely questionnaires completion and submission for all household study participants.	Procedure or surgery	SARS-CoV-2 Surveillance: Total Group

Primary outcome

Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period
Time frame: Baseline through end of study (24 or 28 weeks, depending on if a participant agreed to do the extension)
Nasal samples were analyzed to determine whether a participant ever tested positive for SARS-CoV-2 or not over the course of the study. Kaplan-Meier was used to estimate survival probabilities at timepoints throughout the study. Participants were censored if they did not test positive for SARS-CoV-2 by the end of follow-up. The last positive nasal swab occurred at day 212.

9 secondary outcomes

Percent of Index Participants and Their Household Contacts With Detectable SARS-CoV-2-Specific Antibodies in Serum Over the Study/Surveillance Period
Time frame: Up to Week 24
Number of Index Participants With SARS-CoV-2 Detection in Nasal Samples With Asthma and Other Atopic Disease Compared to Index Participants Without Atopic Disease Over the Study/Surveillance Period
Time frame: Up to Week 24
Percent of Index Participants With Asthma and Other Atopic Disease With Detectable SARS-CoV-2-Specific Antibodies in Serum Compared to Index Participants Without Atopic Disease Over the Study/Surveillance Period
Time frame: Through study completion, an average of 24 Weeks
Changes in the Nasal Transcriptome Associated With Detection of SARS-CoV-2 in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period
Time frame: Up to Week 24
Changes in the Nasal Transcriptome Associated With Detection of SARS-CoV-2 in Nasal Samples Among Index Participants With Asthma and Other Atopic Disease Compared to Index Participants Without Atopic Disease Over the Study/Surveillance Period
Time frame: Up to Week 24
Symptoms Associated With Detection of SARS-CoV-2 in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period
Time frame: Up to Week 24
Number of Index Participants With SARS-CoV-2 Detection in Nasal Samples Using Topical Steroids Compared to Index Participants That Are Not Using Topical Steroids Over the Study/Surveillance Period
Time frame: Up to Week 24
Number of Index Participants With SARS-CoV-2 Detection in Nasal Samples Using Topical, Oral, or Inhaled Steroids Compared to Index Participants That Are Not Using Topical, Oral, or Inhaled Steroids During the Study/Surveillance Period
Time frame: Up to Week 24
Analysis of Factors, Baseline and Prior History, for Possible Association With the Cumulative Incidence of SARS-COV-2 Detection in Nasal Samples: Index Participants and Their Household Contacts Over the Study/Surveillance Period
Time frame: Baseline, Week 24

Results and safety

Results posted to the registry on 5 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Index Participants	1,387	1,012
Non-Index Participants	2,755	2,011

Primary outcome: Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period

Time frame: Baseline through end of study (24 or 28 weeks, depending on if a participant agreed to do the extension). Number (95% Confidence Interval). Unit: Percent surviving using Kaplan-Meier

Measure	Index Participants n = 1387	Non-Index Participants n = 2755	All Participants Combined n = 4142
30 Days	98.9 (98.4 to 99.1)	99.2 (98.8 to 99.5)	99.1 (98.8 to 99.4)
60 Days	98.0 (97.3 to 98.8)	98.4 (97.9 to 98.9)	98.3 (97.9 to 98.7)
90 Days	97.2 (96.3 to 98.1)	97.7 (97.1 to 98.3)	97.5 (97.0 to 98.0)
120 Days	95.8 (94.7 to 96.9)	96.1 (95.3 to 96.9)	96.0 (95.3 to 96.6)
150 Days	94.2 (92.9 to 95.6)	94.3 (93.3 to 95.2)	94.3 (93.5 to 95.1)
180 Days	90.5 (88.5 to 92.7)	91.4 (90.1 to 92.7)	91.1 (90.0 to 92.2)
210 Days	90.1 (87.9 to 92.4)	88.4 (85.3 to 91.7)	89.0 (86.8 to 91.3)
212 Days	90.1 (87.9 to 92.4)	83.5 (77.5 to 89.9)	85.7 (81.5 to 90.1)

Population analysed: Participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Index Participants	0 of 1,387 (0%)	14 of 1,387 (1%)	0 of 1,387
Non-Index Participants	0 of 2,755 (0%)	4 of 2,755 (0.1%)	0 of 2,755

Limitations and caveats (from the sponsor): 34.4% of nasal collections were missed during the study period.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40795882Moore CM, Secor EA, Everman JL, Fairbanks-Mahnke A, Jackson N, Pruesse E, Diener K, Morin A, Arbes SJ, Bacharier LB, Bendixsen CG, Calatroni A, Dupont WD, Furuta GT, Gebretsadik T, Gruchalla RS, Gupta RS, Khurana Hershey GK, Kattan M, Liu AH, Lussier SJ, Murrison LB, Numata M, O'Connor GT, Rivera-Spoljaric K, Phipatanakul W, Rothenberg ME, Seroogy CM, Zoratti EM, Castina S, Jackson DJ, Camargo CA Jr, Johnson CC, Ethridge R, Ramratnam S, Stelzig L, Teach SJ, Togias AG, Fulkerson PC, Hartert TV, Seibold MA. The Common Cold Is Associated With Protection From SARS-CoV-2 Infections. J Infect Dis. 2025 Dec 20;232(6):e920-e930. doi: 10.1093/infdis/jiaf374.
Derived from this study: PubMed 38775275Fulkerson PC, Lussier SJ, Bendixsen CG, Castina SM, Gebretsadik T, Marlin JS, Russell PB, Seibold MA, Everman JL, Moore CM, Snyder BM, Thompson K, Tregoning GS, Wellford S, Arbes SJ, Bacharier LB, Calatroni A, Camargo CA Jr, Dupont WD, Furuta GT, Gruchalla RS, Gupta RS, Hershey GK, Jackson DJ, Johnson CC, Kattan M, Liu AH, Murrison L, O'Connor GT, Phipatanakul W, Rivera-Spoljaric K, Rothenberg ME, Seroogy CM, Teach SJ, Zoratti EM, Togias A, Hartert TV, Heros Study Team OBOT. Human Epidemiology and Response to SARS-CoV-2 (HEROS): objectives, design, and enrollment results of a 12-city remote observational surveillance study of households with children, using direct-to-participant methods. Am J Epidemiol. 2024 Oct 7;193(10):1329-1338. doi: 10.1093/aje/kwae077.
National Institute of Allergy and InfectiousLink provided by the sponsor.
Division of Allergy, Immunology, and TransplantationLink provided by the sponsor.

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Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

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.

Tina V. Hartert, MD, MPH study chair

Vanderbilt University School of Medicine, Dept. of Medicine

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronavirus Disease 2019 (COVID-19) and SARS-CoV-2, run by National Institute of Allergy and Infectious Diseases (NIAID) at 20 sites 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 13 inclusion and 4 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 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites 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?

Yes. Results are posted in the registry (first posted 5 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period (time frame: Baseline through end of study (24 or 28 weeks, depending on if a participant agreed to do the extension)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04375761, which also lists 2 linked publications.

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 6 Aug 2025.