Clinical trial NCT04329546: Understanding COVID-19
Official title: How Immune Responses Shape Virological and Clinical Characteristics of COVID-19: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2 Viral Kinetics and Host Immune Responses
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University of Geneva, Switzerland
First posted: 2020-04-01
Enrollment: 86
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Immunogenicity primary outcome: Geometric mean antibody concentration of total IgG antibodies to SARS-CoV-2 assessed by ELISA at 28 days
timeFrame: assessed at 28 days after diagnosis/presumed diagnosis
measure: Virologic primary outcome: Peak viral load in the 56 days following diagnosis/suspected diagnosis
timeFrame: 56 days after diagnosis/presumed diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospitals of Geneva
Study officials:
affiliation: Professor of vaccinology
name: Claire-Anne Siegrist, MD
role: PRINCIPAL_INVESTIGATOR
References: