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

NCT04368013 | Active Not Recruiting

• 1 other identifier: CoVUm
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Mortality

  Deceased or alive at five year follow-up

  Five years after study start

Study Arms (1)

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

Extended sampling and procedures PROCEDURE

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.

Experimental

Eligibility Criteria

• Age: 15 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Age less than 15 years

Sponsors & Collaborators

• Johan Normark: lead
• Umeå University: collaborator
• Region Västerbotten: collaborator
• Örebro University, Sweden: collaborator
• Värmland County Council, Sweden: collaborator
• Västmanland County Council, Sweden: collaborator

Study Sites (4)

Incectious Diseases Clinic

Umeå, Västerbotten County, 90189, Sweden

Location

Karlstad hospital

Karlstad, Sweden

Location

Örebro university hospital

Örebro, Sweden

Location

Västerås hospital

Västerås, Sweden

Location

Related Publications (6)

• 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.

  PMID: 36057526 RESULT

• 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.

  PMID: 35967397 RESULT

• 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.

  PMID: 33633408 RESULT

• 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.

  PMID: 36995373 RESULT

• 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.

  PMID: 36815689 RESULT

• 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.

  PMID: 36817925 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Serum, Stool, Urine, nasopharynx swabs

MeSH Terms

Conditions

COVID-19

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 29, 2020
• Study Start: April 28, 2020
• Primary Completion: April 14, 2026
• Study Completion: April 14, 2026
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)