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Active, not recruitingNCT04368013CoVUmUpdated Dec 14, 2023

Host-pathogen Interactions, Immune Response, and Clinical Prognosis at COVID-19 - the CoVUm Trial

An observational study in COVID-19, sponsored by Johan Normark. Active, not recruiting at 4 sites in Sweden. Open to participants aged 15 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-12-14.

Sponsored by Johan Normark · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2026, 5 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
550
Ages
15 Years to 100 Years
Sex
All
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Study summary

The project aims to clarify how immunity to SARS-CoV2 develops in humans and to investigate the possibility of finding patients with a particularly effective, neutralizing antibody response for future treatment. The project also aims to detail the virus's damage mechanisms in tissue.

Read the detailed description

There is currently a mounting body of evidence regarding the pathogenesis of COVID-19 caused by SARS-CoV2. By gaining more knowledge about the mechanisms in the development of viral pneumonia and the influence of other organ systems at SARS-CoV2, we believe that in the future it is better to be able to identify precisely those persons who are at risk of serious illness. To this we will gain knowledge of how humans develops immunity to the virus and also how human epigenetic (acquired) ability to activate inflammatory genetic systems can limit the harmful effects of the virus. Thus, patients who have had mild or no symptoms are just as interesting from a study point of view as those who have had severe symptoms. Hopefully, such understanding can also contribute to other opportunities for targeted treatment (by identifying patients who can mount effective inborn and adaptive host defenses) in order to prevent severe disease and death in pandemic corona infection.

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Conditions studied

  • COVID-19

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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 550 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

This is the only study on the registry with Johan Normark as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

A mixed population of individuals suffering from Covid-19 or influenza

Inclusion criteria

  • Patients between 15-100 years with SARS-CoV2 or influenza
  • Patients admitted for COVID-19 or Influenza-caused pneumonia/ pneumonitis at the Departments of Infectious Diseases or ICU, Umeå University Hospital, Örebro hospital, Karlstad hospital and Västerås hospital
  • Patients with COVID-19 who are treated in outpatient care at the infectious Diseases Clinic, Umeå University Hospital, Sweden
  • Patients who give written informed consent to participate in the study for the entire follow- up period of 5 years.

Exclusion criteria

Exclusion Criteria:

  • Age less than 15 years
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
550 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Experimental

    The difference from the standard of care is extended sample collection and study related procedures during the study.

    Procedure: Extended sampling and procedures

Interventions

  • ProcedureExtended sampling and procedures

    The study patients will give additional blood samples and also urine and faeces samples. Spirometry and additional biometric controls will be performed regularly. Necrobiopsies of various organs from deceased patients will be secured and stored for immunohistological and virological analysis.

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What researchers measure

Primary outcomes

  1. Mortality

    Deceased or alive at five year follow-up

    Time frame: Five years after study start

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Study locations

4 sites
  • Incectious Diseases Clinic
    Umeå, Västerbotten 90189, Sweden
  • Karlstad hospital
    Karlstad, Sweden
  • Västerås hospital
    Västerås, Sweden
  • Örebro university hospital
    Örebro, Sweden
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References and documents

Publications

  • Staessen JA, Wendt R, Yu YL, Kalbitz S, Thijs L, Siwy J, Raad J, Metzger J, Neuhaus B, Papkalla A, von der Leyen H, Mebazaa A, Dudoignon E, Spasovski G, Milenkova M, Canevska-Taneska A, Salgueira Lazo M, Psichogiou M, Rajzer MW, Fulawka L, Dzitkowska-Zabielska M, Weiss G, Feldt T, Stegemann M, Normark J, Zoufaly A, Schmiedel S, Seilmaier M, Rumpf B, Banasik M, Krajewska M, Catanese L, Rupprecht HD, Czerwienska B, Peters B, Nilsson A, Rothfuss K, Lubbert C, Mischak H, Beige J; CRIT-CoV-U investigators. Predictive performance and clinical application of COV50, a urinary proteomic biomarker in early COVID-19 infection: a prospective multicentre cohort study. Lancet Digit Health. 2022 Oct;4(10):e727-e737. doi: 10.1016/S2589-7500(22)00150-9. Epub 2022 Aug 31. Erratum In: Lancet Digit Health. 2023 Feb;5(2):e58. doi: 10.1016/S2589-7500(22)00248-5. PubMed 36057526 ↗
  • Schagatay F, Diamant K, Liden M, Edin A, Athlin S, Hultgren O, Ahlm C, Forsell MNE, Savilampi J, Normark J, Lange A, Cajander S. Serum concentration of extracellular cold-inducible RNA-binding protein is associated with respiratory failure in COVID-19. Front Immunol. 2022 Jul 29;13:945603. doi: 10.3389/fimmu.2022.945603. eCollection 2022. PubMed 35967397 ↗
  • Zhou S, Butler-Laporte G, Nakanishi T, Morrison DR, Afilalo J, Afilalo M, Laurent L, Pietzner M, Kerrison N, Zhao K, Brunet-Ratnasingham E, Henry D, Kimchi N, Afrasiabi Z, Rezk N, Bouab M, Petitjean L, Guzman C, Xue X, Tselios C, Vulesevic B, Adeleye O, Abdullah T, Almamlouk N, Chen Y, Chasse M, Durand M, Paterson C, Normark J, Frithiof R, Lipcsey M, Hultstrom M, Greenwood CMT, Zeberg H, Langenberg C, Thysell E, Pollak M, Mooser V, Forgetta V, Kaufmann DE, Richards JB. A Neanderthal OAS1 isoform protects individuals of European ancestry against COVID-19 susceptibility and severity. Nat Med. 2021 Apr;27(4):659-667. doi: 10.1038/s41591-021-01281-1. Epub 2021 Feb 25. PubMed 33633408 ↗
  • Bystrom JW, Vikstrom L, Rosendal E, Groning R, Gwon YD, Nilsson E, Sharma A, Espaillat A, Hanke L, McInerney G, Puhar A, Cava F, Karlsson Hedestam GB, Thunberg T, Monsen T, Elgh F, Evander M, Johansson AF, Overby AK, Ahlm C, Normark J, Forsell MN. At-home sampling to meet geographical challenges for serological assessment of SARS-CoV-2 exposure in a rural region of northern Sweden, March to May 2021: a retrospective cohort study. Euro Surveill. 2023 Mar;28(13):2200432. doi: 10.2807/1560-7917.ES.2023.28.13.2200432. PubMed 36995373 ↗
  • Bjorsell T, Sundh J, Lange A, Ahlm C, Forsell MNE, Tevell S, Blomberg A, Edin A, Normark J, Cajander S. Risk factors for impaired respiratory function post COVID-19: A prospective cohort study of nonhospitalized and hospitalized patients. J Intern Med. 2023 May;293(5):600-614. doi: 10.1111/joim.13614. Epub 2023 Feb 23. PubMed 36815689 ↗
  • Ahmad I, Edin A, Granvik C, Kumm Persson L, Tevell S, Mansson E, Magnuson A, Marklund I, Persson IL, Kauppi A, Ahlm C, Forsell MNE, Sundh J, Lange A, Cajander S, Normark J. High prevalence of persistent symptoms and reduced health-related quality of life 6 months after COVID-19. Front Public Health. 2023 Feb 2;11:1104267. doi: 10.3389/fpubh.2023.1104267. eCollection 2023. PubMed 36817925 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04368013
Lead sponsor
Johan Normark
Collaborators
Umeå University, Region Västerbotten, Örebro University, Sweden, Värmland County Council, Sweden, Västmanland County Council, Sweden
Responsible party
Johan Normark (Associate professor, Umeå University) — Sponsor-investigator
First posted
Apr 29, 2020
Start date
Apr 28, 2020
Primary completion
Apr 14, 2026 (estimated)
Completion
Apr 14, 2026 (estimated)
Last update
Dec 14, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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