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

Active, not recruiting

• Conditions: COVID-19
• Interventions: Procedure: Extended sampling and procedures

• Registration Number: NCT04368013
• Lead Sponsor: Johan Normark

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.

Study Timeline

• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-27
• Study Start: 2020-04-28
• Study First Posted: 2020-04-29
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-14
• Primary Completion: 2026-04-14
• Study Completion: 2026-04-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 550

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental	Extended sampling and procedures	The difference from the standard of care is extended sample collection and study related procedures during the study.

Primary Outcome Measures

Name	Time	Method
Mortality	Five years after study start	Deceased or alive at five year follow-up

Trial Locations

Locations (4)

Karlstad hospital; 🇸🇪 Karlstad, Sweden

Incectious Diseases Clinic; 🇸🇪 Umeå, Västerbotten, Sweden

Örebro university hospital; 🇸🇪 Örebro, Sweden

Västerås hospital; 🇸🇪 Västerås, Sweden