COVID MECH: Mechanisms for Covid-19 Disease Complications

Sponsor

University Hospital, Akershus (Other)

Overall Status

Unknown status

CT.gov ID

NCT04314232

Collaborator

(none)

200

Enrollment

Location

21.5

Anticipated Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID Coronavirus Infection

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Changes in Organ Specific Biomarkers, Virus Expression and Prognosis of Covid-19

Actual Study Start Date :

Mar 18, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Outcome Measures

Primary Outcome Measures

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

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
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
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
Total duration of hospital stay [From hospital admission (baseline) until hospital discharge or death during the index hospitalization (up to 52 weeks)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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