Understanding COVID-19

NCT04329546 | Completed

• 1 other identifier: 2020-00516
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2 Viral Kinetics and Host Immune Responses

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Cases

Cases are patients with COVID-19.

Other: NA (no intervention)

Contacts

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

Other: NA (no intervention)

Interventions

NA (no intervention) OTHER

NA (no intervention)

Cases; Contacts

Eligibility Criteria

• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• Long-term incapacity leading to the inability to provide informed consent while not having a patient representative with the ability to provide informed consent

Sponsors & Collaborators

• University Hospital, Geneva: lead
• University of Geneva, Switzerland: collaborator

Study Sites (1)

University Hospitals of Geneva

Geneva, 1211, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

naso- \& oro-pharyngeal smears, sputum, blood

MeSH Terms

Interventions

Sodium

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Claire-Anne Siegrist, MD

  Professor of vaccinology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of vaccinology

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: April 1, 2020
• Study Start: March 27, 2020
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

CH (1)