Mechanisms for Covid-19 Disease Complications

COVID Clinical Trial

— COVID MECH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04314232
• Other study ID #: 117589
• Status: Recruiting
• Start date: March 18, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2020
• Source: University Hospital, Akershus
• Contact: Torbjørn Omland, MD, PhD
• Phone: 67960000
• Email: torbjorn.omland[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• COVID
• Severe Acute Respiratory Syndrome

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with ICU admission or death	Combined outcome measure of either 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)
Secondary	Number of participants with ICU admission	ICU admission	From hospital admission (baseline) until the date of admission to the ICU during the index hospitalization (up to 52 weeks)
Secondary	Number of participants with death from all causes	Hospital mortality	From hospital admission (baseline) unitl the date of death during the index hospitalization (up to 52 weeks)
Secondary	Total duration of ICU stay	Total time admitted to the ICU	From admission to the ICU until transfer to another ward, discharge from the hospital or death during the index hospitalization (up to 52 weeks)
Secondary	Total duration of hospital stay		From hospital admission (baseline) until hospital discharge or death during the index hospitalization (up to 52 weeks)