COVID-19NCT05234294
Long Covid After COVID-19 Infection With Omicron Variant
An observational study of COVID-19, run by Faroese Hospital System at 1 site in Faroe Islands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- What is being tested?
- Survey
- How many people
- 15,000 participants
- Where
- 1 siteFaroe Islands
- Study dates
- 31 Jan 2022to 7 Aug 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Confirmed COVID-19 during January 2022 in the Faroe Islands.
- Participant in serological survey amongst random sample of Faroese inhabitants in 2020
Who cannot join
- Not reachable
- Confirmed COVID-19 during December 2021 or January 2022
Trial locations and contacts
1 site in 1 country.
Faroe Islands1 site
The Faroses Hospital System
Tórshavn, 100
About this study
Official title: Short and Long Term Symptoms After Omicron Infection in the Faroe Islands
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.
Read more
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.
Read the detailed description
Objectives Primary objective: To investigate Long Covid symptoms after Omicron infection through monthly surveys for six months, compared to controls not infected.
Secondary objective: To investigate acute symptoms during Omicron infection through the first survey shortly after the infection.
Methods All confirmed COVID-19 patients in January 2022 will receive an invitation to participate in an online survey.
We will send the online surveys in two separate bulks. The individuals with confirmed COVID-19 during the first half of January will receive the online survey first, at the same time as half of the controls. The rest of the COVID-19 cases will receive it during the first half of February, along with the rest of the control group.
Outcomes Self-reported symptoms through the online survey compared to the symptoms in the control group.
Hospitalization. Death.
Statistical analyses We will report the results as numbers and percentages. We will stratify analyses by age groups, gender, and previous immunity through infection or vaccination.
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
Variables for COVID-19 cases
- Date of infection
- Previous COVID-19 infection, date
- Vaccination status and dates of vaccination
- Self-reported symptoms during the acute phase of the infection, pre-made list by research group, rated as none, mild, moderate, and severe.
- Option to write in other symptoms.
- Weight and height
- Self-reported severity of the disease course, rated as asymptomatic, mild, moderate, and severe.
- Time to resolution of acute symptoms
- Background information, including education level, current occupational status, smoking, co-morbidities, medicine use, and self-reported health.
- Date of hospitalization, length of hospitalization, date of ICU, length of ICU, date of death.
Variables for controls
- Previous COVID-19 infection, date
- Vaccination status and dates of vaccination
- Self-reported symptoms during the last week, pre-made list by research group, rated as none, mild, moderate, and severe.
- Option to write in other symptoms.
- Weight and height
- Self-reported severity of the disease course, rated as asymptomatic, mild, moderate, and severe.
- Time to resolution of acute symptoms
- Background information, including education level, current occupational status, smoking, co-morbidities, medicine use, and self-reported health.
Publication The results will be published in international scientific journals and press releases on www.health.fo.
Perspectives There is an urgent need to investigate Long Covid after an Omicron infection. This study can provide rapid answers to this question.
Strengths of this planned study include the possibility of performing a nationwide survey and the rapid reporting of both long-term and short-term symptoms.
Limitations include the possibility of a low participation rate.
- Conditions
- COVID-19
- Being tested
- Survey
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
We will investigate symptoms through monthly surveys.
| Study group | Role | What they receive |
|---|---|---|
| Omicron cases | All confirmed COVID-19 cases during January 2022 in the Faroe Islands Receives: Other: Survey | |
| Controls | Participants in previous serological surveys during 2020 in the Faroe Islands. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long Covid after Omicron
Symptoms gathered through survey
Measured: 6 months
Secondary outcomes (1)
Acute symptoms during Omicron infection
Symptoms gathered through survey
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start31 Jan 2022
- Primary completion7 Aug 2022 (estimated)
- Study completion7 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Faroese Hospital System
- Sponsor type
- University, hospital or other
- Collaborators
- Chief Medical Officer's Office Faroe Islands, University of the Faroe Islands, National Hospital of the Faroe Islands
- Responsible party
- Principal investigator, Maria Skaalum Petersen, Faroese Hospital System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234294
- Sponsor's protocol ID
- Omicron
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2022
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared in order to protect the right of the participating individuals.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long Term Symptoms After Omicron Infection in the Faroe Islands
- ClinicalTrials.gov ID
- NCT05234294
- Acronym / sponsor ID
- Omicron
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Faroese Hospital SystemUniversity, hospital or other
- Collaborators
- Chief Medical Officer's Office Faroe Islands, University of the Faroe Islands, National Hospital of the Faroe Islands
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 7 Aug 2022 (estimated)
- Study completion
- 7 Aug 2022 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives Primary objective: To investigate Long Covid symptoms after Omicron infection through monthly surveys for six months, compared to controls not infected.
Secondary objective: To investigate acute symptoms during Omicron infection through the first survey shortly after the infection.
Methods All confirmed COVID-19 patients in January 2022 will receive an invitation to participate in an online survey.
We will send the online surveys in two separate bulks. The individuals with confirmed COVID-19 during the first half of January will receive the online survey first, at the same time as half of the controls. The rest of the COVID-19 cases will receive it during the first half of February, along with the rest of the control group.
Outcomes Self-reported symptoms through the online survey compared to the symptoms in the control group.
Hospitalization. Death.
Statistical analyses We will report the results as numbers and percentages. We will stratify analyses by age groups, gender, and previous immunity through infection or vaccination.
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
Variables for COVID-19 cases
- Date of infection
- Previous COVID-19 infection, date
- Vaccination status and dates of vaccination
- Self-reported symptoms during the acute phase of the infection, pre-made list by research group, rated as none, mild, moderate, and severe.
- Option to write in other symptoms.
- Weight and height
- Self-reported severity of the disease course, rated as asymptomatic, mild, moderate, and severe.
- Time to resolution of acute symptoms
- Background information, including education level, current occupational status, smoking, co-morbidities, medicine use, and self-reported health.
- Date of hospitalization, length of hospitalization, date of ICU, length of ICU, date of death.
Variables for controls
- Previous COVID-19 infection, date
- Vaccination status and dates of vaccination
- Self-reported symptoms during the last week, pre-made list by research group, rated as none, mild, moderate, and severe.
- Option to write in other symptoms.
- Weight and height
- Self-reported severity of the disease course, rated as asymptomatic, mild, moderate, and severe.
- Time to resolution of acute symptoms
- Background information, including education level, current occupational status, smoking, co-morbidities, medicine use, and self-reported health.
Publication The results will be published in international scientific journals and press releases on www.health.fo.
Perspectives There is an urgent need to investigate Long Covid after an Omicron infection. This study can provide rapid answers to this question.
Strengths of this planned study include the possibility of performing a nationwide survey and the rapid reporting of both long-term and short-term symptoms.
Limitations include the possibility of a low participation rate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omicron cases | – | Other: SurveyAll confirmed COVID-19 cases during January 2022 in the Faroe Islands |
| Controls | – | Other: SurveyParticipants in previous serological surveys during 2020 in the Faroe Islands. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Confirmed COVID-19 during January 2022 in the Faroe Islands.
- Participant in serological survey amongst random sample of Faroese inhabitants in 2020
Key exclusion criteria (2 listed)
- Not reachable
- Confirmed COVID-19 during December 2021 or January 2022
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyWe will investigate symptoms through monthly surveys. | Other | Controls, Omicron cases |
Primary outcome
Long Covid after Omicron
Time frame: 6 months
Symptoms gathered through survey
1 secondary outcome
Acute symptoms during Omicron infection
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Individual participant dataSharing planned: No. Individual participant data will not be shared in order to protect the right of the participating individuals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Faroese Hospital System at 1 site in Faroe Islands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Faroe Islands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long Covid after Omicron (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022; AzTrials last refreshed its copy on 6 Nov 2026.