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

COVID-19 Clinical Trial

— CoVUm  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04368013
• Other study ID #: CoVUm
• Status: Active, not recruiting
• Start date: April 28, 2020
• Est. completion date: April 14, 2026

Study information

• Verified date: December 2023
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 550
• Est. completion date: April 14, 2026
• Est. primary completion date: April 14, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 100 Years

Eligibility

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:

• Age less than 15 years

Related Conditions & MeSH terms

• COVID-19

Intervention

Procedure:
• Extended 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.

Locations

Country	Name	City	State
Sweden	Karlstad hospital	Karlstad
Sweden	Örebro university hospital	Örebro
Sweden	Incectious Diseases Clinic	Umeå	Västerbotten
Sweden	Västerås hospital	Västerås

Sponsors (6)

Lead Sponsor	Collaborator
Johan Normark	Örebro University, Sweden, Region Västerbotten, Umeå University, Värmland County Council, Sweden, Västmanland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

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 — View Citation

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. 20 — View Citation

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 — View Citation

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. Fr — View Citation

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-Zabi — View Citation

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, A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Deceased or alive at five year follow-up	Five years after study start