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NCT04375761: HEROS

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

Completed Results posted Last updated 6 August 2025
What this trial tests

trial testing Collection of Biological Samples in Coronavirus Disease 2019 (COVID-19) in 5,599 participants. Completed in 29 March 2021.

Timeline
1 May 2020
Primary endpoint
29 March 2021
29 March 2021

Quick facts

Lead sponsorNational Institute of Allergy and Infectious Diseases (NIAID)
StatusCompleted
Study typeOBSERVATIONAL
Enrollment5,599
Start date1 May 2020
Primary completion29 March 2021
Estimated completion29 March 2021
Sites20 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Eligibility, any sex, with Coronavirus Disease 2019 (COVID-19) or SARS-CoV-2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

30 Days
GroupValue95% CI
Index Participants98.998.4 – 99.1
Non-Index Participants99.298.8 – 99.5
All Participants Combined99.198.8 – 99.4
60 Days
GroupValue95% CI
Index Participants98.097.3 – 98.8
Non-Index Participants98.497.9 – 98.9
All Participants Combined98.397.9 – 98.7
90 Days
GroupValue95% CI
Index Participants97.296.3 – 98.1
Non-Index Participants97.797.1 – 98.3
All Participants Combined97.597.0 – 98.0
120 Days
GroupValue95% CI
Index Participants95.894.7 – 96.9
Non-Index Participants96.195.3 – 96.9
All Participants Combined96.095.3 – 96.6
150 Days
GroupValue95% CI
Index Participants94.292.9 – 95.6
Non-Index Participants94.393.3 – 95.2
All Participants Combined94.393.5 – 95.1
180 Days
GroupValue95% CI
Index Participants90.588.5 – 92.7
Non-Index Participants91.490.1 – 92.7
All Participants Combined91.190.0 – 92.2
210 Days
GroupValue95% CI
Index Participants90.187.9 – 92.4
Non-Index Participants88.485.3 – 91.7
All Participants Combined89.086.8 – 91.3
212 Days
GroupValue95% CI
Index Participants90.187.9 – 92.4
Non-Index Participants83.577.5 – 89.9
All Participants Combined85.781.5 – 90.1

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Index Participants
Serious: 0/1387 (0%)
Deaths: 0/1387
Non-Index Participants
Serious: 0/2755 (0%)
Deaths: 0/2755
Other adverse events (13 terms — click to expand)

ReactionSystemIndex ParticipantsNon-Index Participants
SyncopeNervous system disorders
Vessel puncture site bruiseGeneral disorders
Vessel puncture site swellingGeneral disorders
DizzinessNervous system disorders
EpistaxisRespiratory, thoracic and mediastinal disorders
Vessel puncture site haemorrhageGeneral disorders
Vessel puncture site hypoaesthesiaGeneral disorders
Vessel puncture site painGeneral disorders
Vessel puncture site rashGeneral disorders
ConcussionInjury, poisoning and procedural complications
ContusionInjury, poisoning and procedural complications
Facial bones fractureInjury, poisoning and procedural complications
Dermatitis contactSkin and subcutaneous tissue disorders

Data from ClinicalTrials.gov NCT04375761 adverse events section.

Sponsor's own description

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

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Risk factors for SARS-CoV-2 infection and transmission in households with children with asthma and allergy: A prospective surveillance study.
    Seibold MA, Moore CM, Everman JL, Williams BJM, et al · · 2022 · cited 33× · PMID 35660376 · DOI 10.1016/j.jaci.2022.05.014
  2. 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.
    Fulkerson PC, Lussier SJ, Bendixsen CG, Castina SM, et al · · 2024 · cited 6× · PMID 38775275 · DOI 10.1093/aje/kwae077
  3. The Common Cold Is Associated With Protection From SARS-CoV-2 Infections.
    Moore CM, Secor EA, Everman JL, Fairbanks-Mahnke A, et al · · 2025 · cited 2× · PMID 40795882 · DOI 10.1093/infdis/jiaf374
  4. Caregiver worry about COVID-19 as a predictor of social mitigation behaviours and SARS-CoV-2 infection in a 12-city U.S. surveillance study of households with children.
    Brunwasser SM, Gebretsadik T, Satish A, Cole JC, et al · · 2025 · PMID 39697187 · DOI 10.1016/j.pmedr.2024.102936
  5. Effects of Worry About COVID-19 on Activities that Increase Risk of SARS-CoV-2 Infection in a 12-City Surveillance Study of Households with Children
    Brunwasser SM, Gebretsadik T, Cole JC, Dupont WD, et al · · 2023 · DOI 10.2139/ssrn.4589841
  6. 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
    Fulkerson PC, Lussier SJ, Bendixsen CG, Castina SM, et al · · 2022 · DOI 10.1101/2022.07.09.22277457

Verify or expand the search:

Other recruiting trials for Coronavirus Disease 2019 (COVID-19)

Currently open trials in the same condition.

Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Trials by the same sponsor.

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