Norwegian SARS-CoV-2 Study - Virological, Clinical and Immunological Characterisation of COVID-19
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| ClinicalTrials.gov Identifier: NCT04381819 |
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Recruitment Status :
Recruiting
First Posted : May 11, 2020
Last Update Posted : May 11, 2020
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| Condition or disease | Intervention/treatment |
|---|---|
| SARS Virus Severe Acute Respiratory Syndrome | Diagnostic Test: SARS-CoV-2 PCR |
Infectious disease is the single biggest cause of death worldwide. New infectious agents, such as the SARS-CoV-2, require investigation to understand pathogen biology and pathogenesis in the host. In order to develop a mechanistic understanding of disease processes, such that risk factors for severe illness can be identified and treatments can be developed, it is necessary to understand pathogen characteristics associated with virulence, the replication dynamics and in-host evolution of the pathogen, the dynamics of the host response, the pharmacology of antimicrobial or host directed therapies, the transmission dynamics, and factors underlying individual susceptibility.
At Oslo University Hospital, an observational study on the newly discovered emerging SARS- CoV-2, the coronavirus that causes COVID-19 infection has started. The study has been approved by the Regional Ethics Committee, so that inclusion of confirmed COVID-19 cases admitted at the hospital can start immediately including the first patients needing hospitalisation. The plan is to include more hospitals in other parts of Norway, starting with inclusion of Akershus University Hospital, Vestre Viken Drammen Hospital and Østfold Hospital. The study is anticipated to provide much needed data on the course of the COVID-19 infection, as well as generating knowledge about the virus and its transmission.
| Study Type : | Observational |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Norwegian SARS-CoV-2 Study - Virological, Clinical and Immunological Characterisation of Inpatients During the COVID-19 Outbreak: A Prospective Cohort Study |
| Actual Study Start Date : | March 2, 2020 |
| Estimated Primary Completion Date : | February 28, 2022 |
| Estimated Study Completion Date : | December 31, 2023 |
- Diagnostic Test: SARS-CoV-2 PCR
SARS-CoV-2 E gene
- Death [ Time Frame: From date of randomization until the date of death from any cause assessed up to 3 months. ]Fatal outcome from COVID-19
- Recovery from COVID-19 [ Time Frame: From date of randomization until the date of recovery from COVID-19 symptoms assessed up to 3 months. ]Resolved infection
- Progression to ICU care or ventilation [ Time Frame: 30 days ]Percentage of patients requiring intensive care admission or ventilation
- Clearance of SARS-CoV-2 from respiratory specimen [ Time Frame: 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 ]The change in(clearance of) viral RNA measured by polymerase chain reaction assay (PCR) test at days 1, 3, 8,14 and 90 days
- Immune response to COVID-19 [ Time Frame: From date of randomization until the date of clinical follow-up assessed up to 3 months. ]Cell-mediated and humoral immunity
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Confirmed COVID-19 by screening of SARS-CoV-2 E-gene
Exclusion Criteria:
- Refusal of consent by patient or closest relative
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): NCT04381819
| Contact: Jan C Holter, PhD | +4791195761 ext +4723071155 | jacaho@ous-hf.no | |
| Contact: Susanne G Dudman, PhD | +4723071155 ext +4723071155 | Susanne.Dudman@ous-hf.no |
| Norway | |
| Vestre Viken Drammen Hospital | Recruiting |
| Drammen, Viken, Norway, 3000 | |
| Contact: Lars Heggelund, PhD | |
| Contact Lars.Heggelund@vestreviken.no | |
| Haukeland University Hospital | Recruiting |
| Bergen, Norway, 5021 | |
| Contact: Bjørn Blomberg, PhD | |
| Østfold Hospital Trust | Recruiting |
| Fredrikstad, Norway, 1714 | |
| Contact: Jonas Bergan, phd | |
| Akershus University Hospital | Recruiting |
| Lørenskog, Norway, 1478 | |
| Contact: Christian Prebensen, PhD | |
| Oslo University Hospital | Recruiting |
| Oslo, Norway, 0424 | |
| Contact: Jan C Holter, PhD +4791195761 ext +4791195761 jacaho@ous-hf.no | |
| Contact: Susanne G Dudman, Ass.Professor +4791195761 ext +4791195761 Susanne.Dudman@ous-hf.no | |
| University Hospital North Norway | Recruiting |
| Tromsø, Norway, 9019 | |
| Contact: Anders B Kildal, PhD | |
| St Olavs Hospital | Recruiting |
| Trondheim, Norway, 7030 | |
| Contact: Erik Solligård, PhD | |
| Study Director: | Fredrik G Müller, Professor | University of Oslo | |
| Study Chair: | Susanne G Dudman, Professor | University of Oslo | |
| Principal Investigator: | Jan C Holter, PhD | Oslo University Hospital |
| Responsible Party: | Jan Cato Holter, Project leader, medical doctor, PhD, Oslo University Hospital |
| ClinicalTrials.gov Identifier: | NCT04381819 |
| Other Study ID Numbers: |
20-04072 |
| First Posted: | May 11, 2020 Key Record Dates |
| Last Update Posted: | May 11, 2020 |
| Last Verified: | May 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Severe Acute Respiratory Syndrome Respiratory Tract Infections Infections Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Virus Diseases Respiratory Tract Diseases |