Understanding COVID-19

SARS-CoV-2 Viral Kinetics and Host Immune Responses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04329546
• Other study ID #: 2020-00516
• Status: Completed
• Start date: March 27, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 31, 2021
• Est. primary completion date: October 31, 2021
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• SARS-CoV-2 Viral Kinetics and Host Immune Responses

Intervention

Other:
• NA (no intervention)
NA (no intervention)

Locations

Country	Name	City	State
Switzerland	University Hospitals of Geneva	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	University of Geneva, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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