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COVID 19COMMUNITYNCT06784739

COMMUNITY - the COVID-19 Immunity Study

An observational study of COVID 19 and Respiratory Synctial Virus, run by Danderyd Hospital at 2 sites in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The principal aim of the COMMUNITY study is to investigate immune responses following SARS-CoV-2 infection and/or vaccination in healthcare workers and hospitalized COVID-19 patients. The study aims to enroll a total of 5,000 healthcare workers and 500 COVID-19 patients. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Blood sampling, Mucosal sampling and PCR-test
How many people
2,420 participants
Where
2 sitesSweden
Study dates
15 Apr 2020to Apr 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Danderyd Hospital employs approximately 4,500 healthcare workers. All HCWs are invited to participate in the study through information disseminated via the hospital intranet, email, and word of mouth.

Who may be able to join

  • Health care workers: Employment at Danderyd hospital at time of enrollment
  • COVID-19 patients: Admitted to Danderyd Hospital with confirmed SARS-CoV-2 infection at time of enrollment

Who cannot join

  • No exclusion criteria

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites
  • Danderyd hospital

    Stockholm, 18288

  • Karolinska Institutet Danderyd Hospital

    Stockholm, 18288

Other trials in Sweden

About this study

The principal aim of the COMMUNITY study is to investigate immune responses following SARS-CoV-2 infection and/or vaccination in healthcare workers and hospitalized COVID-19 patients. The study aims to enroll a total of 5,000 healthcare workers and 500 COVID-19 patients. All participants are enrolled at Danderyd Hospital in Stockholm, Sweden. Participants will be followed every four months with blood and mucosal sampling in addition to demographic and clinical data provided by the participants and from national registries.

Primary outcome:

Read more
  • Antibody responses in blood and mucosa following SARS-CoV-2 infection and/or vaccination

Secondary outcomes:

  • Cellular immune responses following SARS-CoV-2 infection and/or vaccination
  • Antibody responses in blood and mucosa following following Influenza A/B infection and/or vaccination
  • Antibody responses in blood and mucosa following following RSV A/B infection

Blood and mucosal samples are collected every 4 months and at tighter intervals in sub studies. PCR testing is conducted upon symptoms of respiratory infections and with regular intervals regardless of symptomatology in sub studies. Participants provide detailed demographic and clinical data through a smart phone application-based questionnaire. Data on infection and vaccination history is collected from national registries

Read the detailed description

The COMMUNITY study is designed to longitudinally follow healthcare workers and recovered COVID-19 patients to assess SARS-CoV-2 immune responses over time. Follow-ups are conducted every four months, including serum, PBMC, and mucosa (saliva and nasal secretions) samples. Sub studies with additional samplings and PCR screenings are conducted with regular intervals to assess vaccine responses and correlates to protection against infection.

Analyses include:

  • Quantification and characterization of antibody responses
  • Evaluation of T and B-cell responses
  • RT-qPCR detection of viral infection
  • Mucosal microbiome evaluation

Clinical and demographic data, including information on hospital workplace, exposure, immunosuppressive treatments or conditions, and results from SARS-CoV-2 Rapid Diagnostic Tests, are collected at each follow-up through a smartphone-based app system. Data on SARS-CoV-2 infections and vaccinations are obtained from national registries. In addition, data from home based PCR-screenings are continuously being monitored for SARS-CoV-2, Influenza and RSV infections.

All samples are stored in Biobank Sweden.

Being tested
Blood sampling, Mucosal sampling, PCR-test
Keywords
COVID-19, Mucosal immunity, Pandemic, Vaccination, Secretory IgA
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood samplingOther

    Venous blood sampling

  • Mucosal samplingOther

    Saliva and nasal secretions

  • PCR-testDiagnostic test

    RT qPCR test to determine infection with SARS-CoV-2, Influenza A/B and/or RSV A/B.

Study groups in NCT06784739
Study groupRoleWhat they receive
The COMMUNITY cohort - healthcare workers5000 healthcare workers employed at Danderyd Hospital at time of enrollment
Receives: Other: Blood sampling; Other: Mucosal sampling; Diagnostic Test: PCR-test
The COMMUNITY cohort - COVID-19 patients500 patients admitted to Danderyd Hospital with confirmed SARS-CoV-2 infection
Receives: Other: Blood sampling; Other: Mucosal sampling; Diagnostic Test: PCR-test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Antibody responses following SARS-CoV-2 infection and/or vaccination

    Antigen-specific IgG and IgA responses in serum, saliva and nasal secretions (trajectories over time and correlates to protection against infection)

    Measured: 2022-2026

Secondary outcomes (3)
  1. Antibody responses following Influenza A/B infection and/or vaccination

    Antigen-specific IgG and IgA responses in serum, saliva and nasal secretions (trajectories over time and correlates to protection against infection)

    Measured: 2022-2026

  2. Antibody responses following RSV infection

    Antigen-specific IgG and IgA responses in serum, saliva and nasal secretions (trajectories over time and correlates to protection against infection)

    Measured: 2020-2026

  3. Cellular immune responses following SARS-CoV-2, Influenza A/B and RSV A/B infection and/or vaccination

    T and B cell responses in blood

    Measured: 2020-2026

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2025
  2. Study start15 Apr 2020
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

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
2,420 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06784739
Sponsor's protocol ID
2020-01653
Other IDs
2020-01653
Acronym
COMMUNITY
Status last verified
Oct 2026
First submitted
16 Jan 2025
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Under consideration

Publications

  • Ng H, Havervall S, Rosell A, Aguilera K, Parv K, von Meijenfeldt FA, Lisman T, Mackman N, Thalin C, Phillipson M. Circulating Markers of Neutrophil Extracellular Traps Are of Prognostic Value in Patients With COVID-19. Arterioscler Thromb Vasc Biol. 2021 Feb;41(2):988-994. doi: 10.1161/ATVBAHA.120.315267. Epub 2020 Dec 3.

    PubMed 33267662
  • Sachetto ATA, Archibald SJ, Hisada Y, Rosell A, Havervall S, van Es N, Nieuwland R, Campbell RA, Middleton EA, Rondina MT, Thalin C, Mackman N. Tissue factor activity of small and large extracellular vesicles in different diseases. Res Pract Thromb Haemost. 2023 Mar;7(3):100124. doi: 10.1016/j.rpth.2023.100124. Epub 2023 Mar 15.

    PubMed 37012986
  • Monteil V, Eaton B, Postnikova E, Murphy M, Braunsfeld B, Crozier I, Kricek F, Niederhofer J, Schwarzbock A, Breid H, Devignot S, Klingstrom J, Thalin C, Kellner MJ, Christ W, Havervall S, Mereiter S, Knapp S, Sanchez Jimenez A, Bugajska-Schretter A, Dohnal A, Ruf C, Gugenberger R, Hagelkruys A, Montserrat N, Kozieradzki I, Hasan Ali O, Stadlmann J, Holbrook MR, Schmaljohn C, Oostenbrink C, Shoemaker RH, Mirazimi A, Wirnsberger G, Penninger JM. Clinical grade ACE2 as a universal agent to block SARS-CoV-2 variants. EMBO Mol Med. 2022 Aug 8;14(8):e15230. doi: 10.15252/emmm.202115230. Epub 2022 Jul 4.

    PubMed 35781796
  • Mravinacova S, Jonsson M, Christ W, Klingstrom J, Yousef J, Hellstrom C, Hedhammar M, Havervall S, Thalin C, Pin E, Tegel H, Nilsson P, Manberg A, Hober S. A cell-free high throughput assay for assessment of SARS-CoV-2 neutralizing antibodies. N Biotechnol. 2022 Jan 25;66:46-52. doi: 10.1016/j.nbt.2021.10.002. Epub 2021 Oct 7.

    PubMed 34628049
  • Havervall S, Jernbom Falk A, Klingstrom J, Ng H, Greilert-Norin N, Gabrielsson L, Salomonsson AC, Isaksson E, Rudberg AS, Hellstrom C, Andersson E, Olofsson J, Skoglund L, Yousef J, Pin E, Christ W, Olausson M, Hedhammar M, Tegel H, Mangsbo S, Phillipson M, Manberg A, Hober S, Nilsson P, Thalin C. SARS-CoV-2 induces a durable and antigen specific humoral immunity after asymptomatic to mild COVID-19 infection. PLoS One. 2022 Jan 12;17(1):e0262169. doi: 10.1371/journal.pone.0262169. eCollection 2022.

    PubMed 35020778
  • von Meijenfeldt FA, Havervall S, Adelmeijer J, Thalin C, Lisman T. Persistent endotheliopathy in the pathogenesis of long COVID syndrome: Comment from von Meijenfeldt et al. J Thromb Haemost. 2022 Jan;20(1):267-269. doi: 10.1111/jth.15580. Epub 2021 Nov 22. No abstract available.

    PubMed 34731533
  • Blom K, Bladh O, Havervall S, Marking U, Greilert Norin N, Alm JJ, Klingstrom J, Thalin C. Point prevalence of SARS-CoV-2 infection among healthcare workers in March and June 2023 in Sweden. Lancet Reg Health Eur. 2023 Aug 30;33:100725. doi: 10.1016/j.lanepe.2023.100725. eCollection 2023 Oct. No abstract available.

    PubMed 37680234
  • von Meijenfeldt FA, Havervall S, Adelmeijer J, Lundstrom A, Magnusson M, Mackman N, Thalin C, Lisman T. Sustained prothrombotic changes in COVID-19 patients 4 months after hospital discharge. Blood Adv. 2021 Feb 9;5(3):756-759. doi: 10.1182/bloodadvances.2020003968. No abstract available.

    PubMed 33560386
  • Havervall S, Rosell A, Phillipson M, Mangsbo SM, Nilsson P, Hober S, Thalin C. Symptoms and Functional Impairment Assessed 8 Months After Mild COVID-19 Among Health Care Workers. JAMA. 2021 May 18;325(19):2015-2016. doi: 10.1001/jama.2021.5612.

    PubMed 33825846
  • Blom K, Marking U, Havervall S, Norin NG, Gordon M, Garcia M, Tecleab T, Christ W, Forsell M, Phillipson M, Nilsson P, Mangsbo S, Hober S, Aberg M, Klingstrom J, Thalin C. Immune responses after omicron infection in triple-vaccinated health-care workers with and without previous SARS-CoV-2 infection. Lancet Infect Dis. 2022 Jul;22(7):943-945. doi: 10.1016/S1473-3099(22)00362-0. Epub 2022 Jun 9. No abstract available.

    PubMed 35691303
  • Havervall S, Marking U, Greilert-Norin N, Gordon M, Ng H, Christ W, Phillipson M, Nilsson P, Hober S, Blom K, Klingstrom J, Mangsbo S, Aberg M, Thalin C. Impact of SARS-CoV-2 infection on vaccine-induced immune responses over time. Clin Transl Immunology. 2022 Apr 18;11(4):e1388. doi: 10.1002/cti2.1388. eCollection 2022.

    PubMed 35444806
  • von Meijenfeldt FA, Havervall S, Adelmeijer J, Lundstrom A, Magnusson M, Mackman N, Thalin C, Lisman T. COVID-19 is Associated with an Acquired Factor XIII Deficiency. Thromb Haemost. 2021 Dec;121(12):1668-1669. doi: 10.1055/a-1450-8414. Epub 2021 May 5. No abstract available.

    PubMed 33742434
  • Blom K, Havervall S, Marking U, Norin NG, Bacchus P, Groenheit R, Brave A, Thalin C, Klingstrom J. Infection Rate of SARS-CoV-2 in Asymptomatic Healthcare Workers, Sweden, June 2022. Emerg Infect Dis. 2022 Oct;28(10):2119-2121. doi: 10.3201/eid2810.221093. Epub 2022 Aug 23.

    PubMed 35997692
  • Bladh O, Aguilera K, Marking U, Kihlgren M, Greilert Norin N, Smed-Sorensen A, Sallberg Chen M, Klingstrom J, Blom K, Russell MW, Havervall S, Thalin C, Aberg M. Comparison of SARS-CoV-2 spike-specific IgA and IgG in nasal secretions, saliva and serum. Front Immunol. 2024 Mar 15;15:1346749. doi: 10.3389/fimmu.2024.1346749. eCollection 2024.

    PubMed 38558811
  • Bladh O, Marking U, Havervall S, Norin NG, Aguilera K, Hober S, Smed-Sorensen A, Gordon M, Blom K, Aberg M, Klingstrom J, Thalin C. Mucosal immune responses following a fourth SARS-CoV-2 vaccine dose. Lancet Microbe. 2023 Jul;4(7):e488. doi: 10.1016/S2666-5247(23)00102-7. Epub 2023 Apr 20. No abstract available.

    PubMed 37086736

Questions about this trial

What is this clinical trial studying?

An observational study of COVID 19 and Respiratory Synctial Virus, run by Danderyd Hospital at 2 sites in Sweden.

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 1 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. 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?

This study is still under way. Results are not available in the source record yet.

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?

Antibody responses following SARS-CoV-2 infection and/or vaccination (time frame: 2022-2026). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06784739, which also lists 19 linked publications.

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 7 Oct 2026.

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