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

Sponsor
Johan Normark (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04368013
Collaborator
Umeå University (Other), Region Västerbotten (Other)
400
1
1
71.5
5.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Extended sampling and procedures
N/A

Detailed Description

There is currently no specific treatment for 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 Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Host-pathogen Interactions, Immune Response, and Clinical Prognosis at COVID-19 - the CoVUm Trial
Anticipated Study Start Date :
Apr 28, 2020
Anticipated Primary Completion Date :
Apr 14, 2026
Anticipated Study Completion Date :
Apr 14, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Outcome Measures

Primary Outcome Measures

  1. Mortality [Five years after study start]

    Deceased or alive at five year follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients between 15-100 years with SARS-CoV2

  • Patients admitted for COVID-19-caused pneumonia / pneumonitis at the Department of Infectious Diseases or ICU, Umeå University Hospital.

  • Patients with COVID-19 who are treated in outpatient care at the infectious Diseases Clinic, Umeå University Hospital.

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Incectious Diseases Clinic Umeå Västerbotten Sweden 90189

Sponsors and Collaborators

  • Johan Normark
  • Umeå University
  • Region Västerbotten

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johan Normark, Associate professor, Umeå University
ClinicalTrials.gov Identifier:
NCT04368013
Other Study ID Numbers:
  • CoVUm
First Posted:
Apr 29, 2020
Last Update Posted:
Apr 29, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 29, 2020