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COVID-19CoVUmNCT04368013

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

An observational study of COVID-19, run by Johan Normark at 4 sites in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 15 to 100 years
Conditions the study is for
COVID-19
What is being tested?
Extended sampling and procedures
Type of treatment
Surgery or procedure
How many people
550 participants
Where
4 sitesSweden
Study dates
28 Apr 2020to 14 Apr 2026
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 15 to 100 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • Age less than 15 years

Trial locations and contacts

4 sites in 1 country.

Sweden4 sites

  • Karlstad hospital

    Karlstad

  • Örebro university hospital

    Örebro

  • Incectious Diseases Clinic

    Umeå, Västerbotten County, 90189

  • Västerås hospital

    Västerås

Other trials in Sweden

About this study

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.

Conditions
COVID-19
Being tested
Extended sampling and procedures
Medical subject headings
COVID-19

What participants receive

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

  • Extended sampling and proceduresProcedure or surgery

    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.

Study groups in NCT04368013
Study groupRoleWhat they receive
ExperimentalThe difference from the standard of care is extended sample collection and study related procedures during the study.
Receives: Procedure: Extended sampling and procedures

What is being measured

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

  1. Mortality

    Deceased or alive at five year follow-up

    Measured: Five years after study start

Timeline

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

  1. First posted29 Apr 2020
  2. Study start28 Apr 2020
  3. Primary completion14 Apr 2026 (estimated)
  4. Study completion14 Apr 2026 (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
550 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04368013
Sponsor's protocol ID
CoVUm
Acronym
CoVUm
Status last verified
Dec 2023
First submitted
27 Apr 2020
Last updated
14 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    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

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Johan Normark at 4 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 4 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: status not confirmed, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

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?

Mortality (time frame: Five years after study start). 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 NCT04368013, which also lists 6 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 14 Dec 2023.

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