Understanding COVID-19

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

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2 Viral Kinetics and Host Immune Responses
• Intervention / Treatment: Other: NA (no intervention)

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.

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • University Hospitals of Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; Cases are patients with COVID-19.	Other: NA (no intervention); NA (no intervention)
Contacts; Contacts are household contacts of an index (case) patient.	Other: NA (no intervention); NA (no intervention)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	assessed at 28 days after diagnosis/presumed diagnosis
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.	56 days after diagnosis/presumed diagnosis

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Collaborators: University of Geneva, Switzerland
• Investigators: Principal Investigator: Claire-Anne Siegrist, MD, Professor of vaccinology

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2020
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: March 29, 2020
• First Submitted That Met QC Criteria: March 29, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 22, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2020-00516

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No