NCT05042193

Brief Summary

The primary objective of this study is to describe the longevity of IgG against SARS-CoV-2 infection or vaccination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,883

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2022

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

1.2 years

First QC Date

September 9, 2021

Last Update Submit

June 14, 2022

Conditions

SARS-CoV-2 Acute Respiratory Disease

Outcome Measures

Primary Outcomes (1)

  • To describe the longevity and seroprevalence of IgG against SARS-CoV-2 in a cohort of individuals exposed to SARS-CoV-2

    Up to 9 months

Secondary Outcomes (2)

  • To compare the off-kinetics of IgG positivity against SARS-CoV-2, stratified by age, sex, race, ethnicity, infection symptomaticity, initial viral load

    Up to 9 months

  • To compare the off-kinetics of IgG positivity against SARS-CoV-2 by natural infection vs vaccination

    Up to 9 months

Study Arms (2)

Unvaccinated SARS-CoV-2 positive

Participants who have tested positive for SARS-CoV-2, both with and without symptoms, who have not been vaccinated

Other: SARS-CoV-2

Vaccinated

Participants who were vaccinated against SARS-CoV-2

Other: SARS-CoV-2

Interventions

SARS-CoV-2OTHER

Observational

Unvaccinated SARS-CoV-2 positiveVaccinated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants who have tested positive for SARS-CoV-2 by either RT-PCR or Antigen test for COVID-19 or have received one of the commercially available SARS-CoV-2 vaccines.

You may qualify if:

  • Age ≥ 18 years
  • Willing to provide informed consent prior to participation.
  • Cohort 1 (Arm 1) - Positive test results for SARS-CoV-2 virus by an RT-PCR or Antigen test AND not received any COVID-19 vaccine or participated in any COVID-19 vaccine trial
  • Cohort 2 (Arm 2) - Received the COVID-19 vaccine

You may not qualify if:

  • Unable or unwilling to provide informed consent
  • Individuals with known conditions or treatments associated with immune impairment, such as cancer and chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Everlywell, Inc

Austin, Texas, 78703, United States

Location

Study Officials

  • Timothy Bauer, PhD

    Everly Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2021

First Posted

September 13, 2021

Study Start

March 19, 2021

Primary Completion

May 31, 2022

Study Completion

June 14, 2022

Last Updated

June 15, 2022

Record last verified: 2022-06

Locations

US(1)