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CompletedNCT04329546Updated May 24, 2022

Understanding COVID-19

An observational study in SARS-CoV-2 Viral Kinetics and Host Immune Responses, sponsored by University Hospital, Geneva. Completed at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2022-05-24.

Sponsored by University Hospital, Geneva · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
86
Sex
All
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Study summary

This single-center prospective observational study will examine immune responses to to SARS-CoV-2 and how they correlate with its virological characteristics and clinical manifestations in infected patients. Household contacts will also be included so that early immune responses and viral kinetics can be captured. Patients and contacts will be followed for 8 and 2 weeks, respectively. The study will include a maximum of 250 participants.

Read the detailed description

The primary aim of this single-center prospective observational study is to establish how immune responses to SARS-CoV-2 or to cross-reactive viruses correlate with the virological and clinical characteristics of SARS- CoV-2-infected patients and their exposed household contacts. Through iterative sampling, the viral kinetics of at least 50 infected patients will be evaluated in relation to symptom severity and innate and adaptive immune responses, while their household contacts will be observed for viral detection and immune responses. Patients and contacts will be followed for 8 and 2 weeks, respectively. The study will include a maximum of 250 participants.

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Conditions studied

  • SARS-CoV-2 Viral Kinetics and Host Immune Responses
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In context

Lead sponsor

University Hospital, Geneva is the lead sponsor of 372 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Adults and children of all ages either infected with, or presumed to be infected with SARS-CoV-2, and their household contacts.

Inclusion criteria

The following persons may be included:

  • A patient of any age meeting the European Centre for Disease Control and Prevention's confirmed case definition: "A person with laboratory confirmation of virus causing COVID-19, irrespective of clinical signs and symptoms" (and/or high suspicion/actively being treated as CoVID+ cases pending test confirmation)
  • Household contacts (defined as those sleeping in the same apartment/house as an infected patient) of a patient with laboratory-confirmed COVID-19 (and/or high suspicion/actively being treated as CoVID+ cases pending test confirmation), whether symptomatic or not, and whether testing positive or not during a period of 14 days

Exclusion criteria

Exclusion Criterion:

  • Long-term incapacity leading to the inability to provide informed consent while not having a patient representative with the ability to provide informed consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
86 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Cases

    Cases are patients with COVID-19.

    Other: NA (no intervention)

  • Contacts

    Contacts are household contacts of an index (case) patient.

    Other: NA (no intervention)

Interventions

  • OtherNA (no intervention)

    NA (no intervention)

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What researchers measure

Primary outcomes

  1. Immunogenicity primary outcome: Geometric mean antibody concentration of total IgG antibodies to SARS-CoV-2 assessed by ELISA at 28 days

    Geometric mean antibody concentration of total IgG antibodies to SARS-CoV-2 assessed by ELISA at 28 days after diagnosis/suspected diagnosis

    Time frame: assessed at 28 days after diagnosis/presumed diagnosis

  2. Virologic primary outcome: Peak viral load in the 56 days following diagnosis/suspected diagnosis

    Peak viral load in the 56 days following diagnosis/suspected diagnosis, quantified by real-time reverse-transcriptase polymerase chain reaction (RT-PCR) on nasopharyngeal swabs.

    Time frame: 56 days after diagnosis/presumed diagnosis

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Study locations

1 site
  • University Hospitals of Geneva
    Geneva, 1211, Switzerland
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References and documents

Individual participant data

Plan to share: Undecided — Fully anonymized data that are not already published may be shared on reasonable request from a qualified investigator, at the discretion of the Project Leader.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04329546
Lead sponsor
University Hospital, Geneva
Collaborators
University of Geneva, Switzerland
Responsible party
Siegrist Claire-Anne (Professor of vaccinology, University Hospital, Geneva) — Principal investigator
First posted
Apr 1, 2020
Start date
Mar 27, 2020
Primary completion
Oct 31, 2021
Completion
Dec 31, 2021
Last update
May 24, 2022

Study contacts

Claire-Anne Siegrist, MD
principal investigator · Professor of vaccinology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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