Long Covid After COVID-19 Infection With Omicron Variant

NCT05234294 | Unknown DMC FDA Drug

• 1 other identifier: Omicron
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief Summary

The COVID-19 pandemic has led to a high disease burden worldwide, both during the acute disease phase and a large group of infected suffering from Long Covid. Long Covid has been subject to a lot of research, even though there is still much not understood. However, the need for time to pass before symptoms can be assessed limits research into Long Covid on a longer timescale. The worldwide pandemic has shifted after the emergence of the Omicron variant. The number of confirmed COVID cases worldwide has risen to unprecedented levels. Yet, hospitalizations and death do not increase at the same level as with previous variants. The observed shift in the pandemic with the increasing number of infections with the Omicron variant leads to the urgent question about Long Covid after Omicron infection. This rise has also taken place in the Faroe Islands, with many infections during December 2021 and January 2022. The majority of infections during January 2022 in the Faroe Islands are expected to be of the Omicron variant, presenting the opportunity to investigate symptoms after infection with the Omicron variant. In this study, we will invite all infected with COVID-19 during January 2022 in the Faroe Islands to answer an online survey regarding symptoms. This survey will be sent out once a month for a total of six times, both focusing on acute symptoms and Long Covid symptoms. Concurrently, we will send an online survey to Faroese inhabitants recruited in two separate random COVID-19 serological surveys during 2020, which will act as controls. The knowledge gathered during this study will rapidly bring understanding to the urgent question of Long Covid after Omicron infections. We know that the Omicron variant leads to fewer hospitalizations and death than previous variants, yet the question of Long Covid is still unanswered, and needs rapid answers.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Long Covid after Omicron

  Symptoms gathered through survey

  6 months

Secondary Outcomes (1)

• Acute symptoms during Omicron infection

  1 month

Other Outcomes (2)

• Death

  6 months

• Hospitalization

  6 months

Study Arms (2)

Omicron cases

All confirmed COVID-19 cases during January 2022 in the Faroe Islands

Other: Survey

Controls

Participants in previous serological surveys during 2020 in the Faroe Islands.

Other: Survey

Interventions

Survey OTHER

We will investigate symptoms through monthly surveys.

Controls; Omicron cases

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The target population is all infected Faroese COVID-19 patients during January 2022, when Omicron is expected to make up the majority of cases. Controls will be participants in two separate serological surveys with randomly selected individuals that have not had COVID-19 during December 2021 and January 2022

You may qualify if:

• Confirmed COVID-19 during January 2022 in the Faroe Islands.

You may not qualify if:

• Not reachable
• Participant in serological survey amongst random sample of Faroese inhabitants in 2020
• Confirmed COVID-19 during December 2021 or January 2022

Sponsors & Collaborators

• Faroese Hospital System: lead
• Chief Medical Officer's Office Faroe Islands: collaborator
• University of the Faroe Islands: collaborator
• National Hospital of the Faroe Islands: collaborator

Study Sites (1)

The Faroses Hospital System

Tórshavn, 100, Faroe Islands

Location

MeSH Terms

Conditions

COVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 10, 2022
• Study Start: January 31, 2022
• Primary Completion: August 7, 2022
• Study Completion: August 7, 2022
• Last Updated: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FA (1)