NCT04381819

Brief Summary

Oslo University Hospital has initiated an observational study on hospitalised patients with confirmed COVID-19, the infection caused by Severe Acute Respiratory Syndrome Coronavirus type 2 (SARS-CoV-2).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 11, 2020

Status Verified

May 1, 2020

Enrollment Period

2 years

First QC Date

May 4, 2020

Last Update Submit

May 8, 2020

Conditions

SARS VirusSevere Acute Respiratory Syndrome

Outcome Measures

Primary Outcomes (3)

  • Death

    Fatal outcome from COVID-19

    From date of randomization until the date of death from any cause assessed up to 3 months.

  • Recovery from COVID-19

    Resolved infection

    From date of randomization until the date of recovery from COVID-19 symptoms assessed up to 3 months.

  • Progression to ICU care or ventilation

    Percentage of patients requiring intensive care admission or ventilation

    30 days

Secondary Outcomes (2)

  • Clearance of SARS-CoV-2 from respiratory specimen

    The number of calendar days from date of PCR positive test (counted as 1 day) in respiratory specimen until date of such test first become negative in the respiratory specimen assessed up to 3 months

  • Immune response to COVID-19

    From date of randomization until the date of clinical follow-up assessed up to 3 months.

Interventions

SARS-CoV-2 PCRDIAGNOSTIC_TEST

SARS-CoV-2 E gene

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to Oslo University Hospital, Vestre Viken Drammen Hospital, Akershus University Hospital or Østfold Hospital Kalnes will be recruited consecutively after testing positive for SARS-CoV-2

You may qualify if:

  • Confirmed COVID-19 by screening of SARS-CoV-2 E-gene

You may not qualify if:

  • Refusal of consent by patient or closest relative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Vestre Viken Drammen Hospital

Drammen, Akershus, 3000, Norway

RECRUITING

Haukeland University Hospital

Bergen, 5021, Norway

RECRUITING

Østfold Hospital Trust

Fredrikstad, 1714, Norway

RECRUITING

Akershus University Hospital

Lørenskog, 1478, Norway

RECRUITING

Oslo University Hospital

Oslo, 0424, Norway

RECRUITING

University Hospital North Norway

Tromsø, 9019, Norway

RECRUITING

St Olavs Hospital

Trondheim, 7030, Norway

RECRUITING

Related Publications (2)

  • Troseid M, Holter JC, Holm K, Vestad B, Sazonova T, Granerud BK, Dyrhol-Riise AM, Holten AR, Tonby K, Kildal AB, Heggelund L, Tveita A, Boe S, Muller KE, Jenum S, Hov JR, Ueland T; Norwegian SARS-CoV-2 study group. Gut microbiota composition during hospitalization is associated with 60-day mortality after severe COVID-19. Crit Care. 2023 Feb 23;27(1):69. doi: 10.1186/s13054-023-04356-2.

    PMID: 36814280DERIVED

  • Tveita A, Murphy SL, Holter JC, Kildal AB, Michelsen AE, Lerum TV, Kaarbo M, Heggelund L, Holten AR, Finbraten AK, Muller KE, Mathiessen A, Boe S, Fevang B, Granerud BK, Tonby K, Lind A, Dudman SG, Henriksen KN, Muller F, Skjonsberg OH, Troseid M, Barratt-Due A, Dyrhol-Riise AM, Aukrust P, Halvorsen B, Dahl TB, Ueland T; NOR-SOLIDARITY Consortium and the Norwegian SARS-CoV-2 Study Group Investigators. High Circulating Levels of the Homeostatic Chemokines CCL19 and CCL21 Predict Mortality and Disease Severity in COVID-19. J Infect Dis. 2022 Dec 13;226(12):2150-2160. doi: 10.1093/infdis/jiac313.

    PMID: 35876699DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Respiratory secretions, blood, urine, stool, cerebrospinal fluid

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Interventions

COVID-19 Nucleic Acid Testing

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

COVID-19 TestingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Fredrik G Müller, Professor

    University of Oslo

    STUDY DIRECTOR

  • Susanne G Dudman, Professor

    University of Oslo

    STUDY CHAIR

  • Jan C Holter, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan C Holter, PhD

CONTACT

+4791195761jacaho@ous-hf.no

Susanne G Dudman, PhD

CONTACT

+4723071155Susanne.Dudman@ous-hf.no

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project leader, medical doctor, PhD

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 11, 2020

Study Start

March 2, 2020

Primary Completion

February 28, 2022

Study Completion

December 31, 2023

Last Updated

May 11, 2020

Record last verified: 2020-05

Locations

NO(7)