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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368013
Recruitment Status : Not yet recruiting
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Collaborators:
Umeå University
Västerbotten County Council
Information provided by (Responsible Party):
Johan Normark, Umeå University

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
COVID-19 Procedure: Extended sampling and procedures Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : April 28, 2020
Estimated Primary Completion Date : April 14, 2026
Estimated Study Completion Date : April 14, 2026

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.




Primary Outcome Measures :
  1. Mortality [ Time Frame: Five years after study start ]
    Deceased or alive at five year follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368013


Contacts
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Contact: Alicia Edin, M.D. +46907850000 alicia.edin@umu.se
Contact: Johan Normark, Docent +46907850000 johan.normark@umu.se

Locations
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Sweden
Incectious Diseases Clinic
Umeå, Västerbotten, Sweden, 90189
Contact: Alicia Edin, M.D.    +46907850000    alicia.edin@umu.se   
Principal Investigator: Johan Normark, Docent         
Sub-Investigator: Clas Ahlm, Professor         
Sponsors and Collaborators
Johan Normark
Umeå University
Västerbotten County Council
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Responsible Party: Johan Normark, Associate professor, Umeå University
ClinicalTrials.gov Identifier: NCT04368013    
Other Study ID Numbers: CoVUm
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No