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The (World Health Organization) WHO NOR- (Coronavirus infectious disease) COVID 19 study is a multi-centre, adaptive, randomized, open clinical trial to evaluate the safety and efficacy of hydroxychloroquine, remdesivir and standard of care in hospitalized adult patients diagnosed with COVID-19. This trial will follow the core WHO protocol but has additional efficacy, safety and explorative endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxychloroquine | Active Comparator |
| |
| Remdesivir | Active Comparator |
| |
| Control group - SoC | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | Hydroxychloroquine will be given orally (in the ICU in gastrointestinal tubes) with 800 mg x 2 loading dose followed by 400 mg x 2 every day for a total of 10 days. |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital mortality | All cause in-hospital mortality | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence and duration of mechanical ventilation | 3 weeks | |
| Occurrence and duration of intensive care unit (ICU) treatment | 3 weeks | |
| Duration of hospital admittance |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory and anti-inflammatory mediators as assessed in serum and plasma | Throughout hospitalization | |
| Markers of extracellular matrix remodeling | Throughout hospitalization and 3 months after remission |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul Aukrust, MD, Professor | Contact | 0047 46778374 | paukrust@ous-hf.no | |
| Andreas Barratt-Due, MD, PhD | Contact | 0047 98209974 | andreas.barrattdue@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Paul Aukrust, MD, Professor | Oslo University Hospital | Study Chair |
| Andreas Barratt-Due, MD, PhD | Oslo University Hospital | Principal Investigator |
| Trine Kåsine, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andreas Barratt-Due | Recruiting | Oslo | 0756 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39533001 | Derived | Patrick-Brown TDJH, Barratt-Due A, Troseid M, Dyrhol-Riise AM, Nezvalova-Henriksen K, Kasine T, Aukrust P, Olsen IC; NOR Solidarity consortium. The effects of remdesivir on long-term symptoms in patients hospitalised for COVID-19: a pre-specified exploratory analysis. Commun Med (Lond). 2024 Nov 12;4(1):231. doi: 10.1038/s43856-024-00650-4. | |
| 36695483 |
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All patients included in this study will automatically be included in the WHO COVID 19 protocol
The study will end according the requirements to WHO
WHO COVID 19 investigators
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| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| C000606551 | remdesivir |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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An open randomized adaptive controlled trial
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| Remdesivir | Drug | Remdesivir will be given intravenously 100 mg daily for the duration of the hospitalization and up to 10 days total course. A loading dose of 200 mg at inclusion will be given. |
|
| (Standard of Care) SoC | Other | The standard of care will be supplied to all patients not receiving a drug intervention. |
|
| 1 month |
| 28 Day mortality | 3 weeks |
| Viral clearance as assessed by SARS-CoV-2 PCR in peripheral blood and nasopharyngeal airway speciemen | 3 weeks |
| Occurrence of co-infections | 3 weeks |
| Occurrence of organ dysfunction | 3 months |
| Markers of endothelial activation | Throughout hospitalization |
| Markers of platelet activation | Throughout hospitalization |
| Oslo University Hospital |
| Principal Investigator |
| Katerina Nezvalova-Henriksen, Pharm D, PhD | Oslo Hospital Pharmacies | Principal Investigator |
| Anne Margarita Dyrhol Riise, MD, Professor | Oslo University Hospital | Principal Investigator |
| Marius Trøseid, MD, PhD | Oslo University Hospital | Principal Investigator |
| Inge Christoffer Olsen, PhD | NorCRIN | Principal Investigator |
| Grundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2. |
| 35876699 | Derived | 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. |
| 34350582 | Derived | Ansems K, Grundeis F, Dahms K, Mikolajewska A, Thieme V, Piechotta V, Metzendorf MI, Stegemann M, Benstoem C, Fichtner F. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD014962. doi: 10.1002/14651858.CD014962. |
| 34251903 | Derived | Barratt-Due A, Olsen IC, Nezvalova-Henriksen K, Kasine T, Lund-Johansen F, Hoel H, Holten AR, Tveita A, Mathiessen A, Haugli M, Eiken R, Kildal AB, Berg A, Johannessen A, Heggelund L, Dahl TB, Skara KH, Mielnik P, Le LAK, Thoresen L, Ernst G, Hoff DAL, Skudal H, Kittang BR, Olsen RB, Tholin B, Ystrom CM, Skei NV, Tran T, Dudman S, Andersen JT, Hannula R, Dalgard O, Finbraten AK, Tonby K, Blomberg B, Aballi S, Fladeby C, Steffensen A, Muller F, Dyrhol-Riise AM, Troseid M, Aukrust P; NOR-Solidarity trial. Evaluation of the Effects of Remdesivir and Hydroxychloroquine on Viral Clearance in COVID-19 : A Randomized Trial. Ann Intern Med. 2021 Sep;174(9):1261-1269. doi: 10.7326/M21-0653. Epub 2021 Jul 13. |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |