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

December 7, 2023 updated by: Johan Normark
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Karlstad, Sweden
        • Karlstad Hospital
      • Västerås, Sweden
        • Västerås Hospital
      • Örebro, Sweden
        • Örebro University Hospital
    • Västerbotten
      • Umeå, Västerbotten, Sweden, 90189
        • Incectious Diseases Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental
The difference from the standard of care is extended sample collection and study related procedures during the study.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Five years after study start
Deceased or alive at five year follow-up
Five years after study start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johan Normark

Collaborators

Umeå University
Värmland County Council, Sweden
Örebro University, Sweden
Region Västerbotten
Västmanland County Council, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2020

Primary Completion (Estimated)

April 14, 2026

Study Completion (Estimated)

April 14, 2026

Study Registration Dates

First Submitted

April 27, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 29, 2020

Study Record Updates

Last Update Posted (Actual)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CoVUm

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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