Clinical trial NCT04368013: Host-pathogen Interactions, Immune Response, and Clinical Prognosis at COVID-19 - the CoVUm Trial
Official title: Host-pathogen Interactions, Immune Response, and Clinical Prognosis at COVID-19 - the CoVUm Trial
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Umeå University
name: Region Västerbotten
name: Örebro University, Sweden
name: Värmland County Council, Sweden
name: Västmanland County Council, Sweden
First posted: 2020-04-29
Enrollment: 550
Sex: ALL
Minimum age (years): 15
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A mixed population of individuals suffering from Covid-19 or influenza

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: Five years after study start
Secondary outcomes:
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Incectious Diseases Clinic
state: Västerbotten
city: Karlstad
country: Sweden
facility: Karlstad hospital
city: Västerås
country: Sweden
facility: Västerås hospital
city: Örebro
country: Sweden
facility: Örebro university hospital
Study officials:
References:
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