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Mechanisms for Covid-19 Disease Complications (COVID MECH)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04314232
Recruitment Status : Unknown
Verified June 2020 by Torbjorn Omland, University Hospital, Akershus.
Recruitment status was:  Recruiting
First Posted : March 19, 2020
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Torbjorn Omland, University Hospital, Akershus

Study Description
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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
COVID Coronavirus Infection

Study Design
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Study Type : Observational
Estimated 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 : March 18, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with ICU admission or death [ Time Frame: 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 :
  1. Number of participants with ICU admission [ Time Frame: From hospital admission (baseline) until the date of admission to the ICU during the index hospitalization (up to 52 weeks) ]
    ICU admission

  2. Number of participants with death from all causes [ Time Frame: From hospital admission (baseline) unitl the date of death during the index hospitalization (up to 52 weeks) ]
    Hospital mortality

  3. Total duration of ICU stay [ Time Frame: 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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients with a positive test for SARS-CoV2 admitted to Akershus University Hospital.
Criteria

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
Contacts and Locations
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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): NCT04314232


Contacts
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Contact: Torbjørn Omland, MD, PhD 67960000 torbjorn.omland@medisin.uio.no

Locations
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Norway
Akershus University Hospital Recruiting
Lørenskog, Norway
Contact: Peder Myhre, MD, PhD    6790000    p.l.myhre@medisin.uio.no   
Sponsors and Collaborators
University Hospital, Akershus
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Torbjorn Omland, Professor, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT04314232    
Other Study ID Numbers: 117589
First Posted: March 19, 2020    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Torbjorn Omland, University Hospital, Akershus:
Covid-19
Biomarkers
Cardiovascular disease
Prognosis
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
 Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases