Understanding COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-27

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Understanding Immunity to SARS-CoV-2, the Coronavirus Causing COVID-19

NCT04373148

Coronavirus

COMPLETED

A COVID-19 Symptom, Exposure and Immune Response Registry

NCT04348942

COVID-19

COMPLETED

Development and Qualification of Methods for Analyzing the Mucosal Immune Response to COVID-19

NCT06142279

Certain Disorders Involving the Immune Mechanism

NOT_YET_RECRUITING NA

Characterizing the Immune Response and Neuronal Damage in COVID-19

NCT04510012

SARS-CoV Infection Covid-19

COMPLETED

Predictive Immune Biomarkers of COVID-19 Pathogenesis to Influence Therapeutic Management

NCT04668170

COVID-19

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

SARS-CoV-2 Viral Kinetics and Host Immune Responses

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cases

Cases are patients with COVID-19.

NA (no intervention)

Intervention Type OTHER

NA (no intervention)

Contacts

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

NA (no intervention)

Intervention Type OTHER

NA (no intervention)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NA (no intervention)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No