Mechanisms for Covid-19 Disease Complications

• Conditions: COVID; Coronavirus Infection

• Registration Number: NCT04314232
• Lead Sponsor: University Hospital, Akershus

Brief Summary

Covid-19 is associated with a wide range of symptoms and clinical trajectories, and early identification of patients at risk for developing severe disease is desirable. Several risk markers and comorbidity profiles have been proposed but their relative importance in unselected patients admitted to hospital with Covid-19 remains unclear. This study aims to assess the prognostic value organ specific biomarkers, viral dynamics and immune response markers in patients infected with SARS-CoV2.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-03-17
• Study Start: 2020-03-18
• Study First Posted: 2020-03-19
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-24
• Last Update Posted: 2020-06-26
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• All patients >18 years of age with a positive test for SARS-CoV2 are eligble for inclusion.
• Healty age-matched volunteers will be included as a control group

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with ICU admission or death	From hospital admission (baseline) until the date of either admission to the ICU or death during the index hospitalization (up to 52 weeks)	Combined outcome measure of either ICU admission or death

Secondary Outcome Measures

Name	Time	Method
Number of participants with ICU admission	From hospital admission (baseline) until the date of admission to the ICU during the index hospitalization (up to 52 weeks)	ICU admission
Total duration of hospital stay	From hospital admission (baseline) until hospital discharge or death during the index hospitalization (up to 52 weeks)
Total duration of ICU stay	From admission to the ICU until transfer to another ward, discharge from the hospital or death during the index hospitalization (up to 52 weeks)	Total time admitted to the ICU
Number of participants with death from all causes	From hospital admission (baseline) unitl the date of death during the index hospitalization (up to 52 weeks)	Hospital mortality

Trial Locations

Locations (1)

Akershus University Hospital; 🇳🇴 Lørenskog, Norway