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OpenTrials
Completed

NCT Number: NCT04329546

Understanding COVID-19

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals of Geneva

Geneva, 1211, Switzerland

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

NA (no intervention)

Other

NA (no intervention)

Primary outcomes

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

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

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

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

    Time frame: 56 days after diagnosis/presumed 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • University of Geneva, Switzerland

Registry information

Official study title

How Immune Responses Shape Virological and Clinical Characteristics of COVID-19: a Prospective Cohort Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2020
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.