Understanding COVID-19

University Hospitals (UH)

Status: Completed

Conditions: SARS-CoV-2 Viral Kinetics and Host Immune Responses

Treatments: Other: NA (no intervention)

Study type: Observational

Funder types: Other

Identifiers

NCT04329546

2020-00516

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

86 participants in 2 patient groups

Cases

Description:

Cases are patients with COVID-19.

Treatment:

Other: NA (no intervention)

Contacts

Description:

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

Treatment:

Other: NA (no intervention)