- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04321616
The Efficacy of Different Anti-viral Drugs in COVID 19 Infected Patients
April 10, 2020 updated by: Andreas Barratt-Due, Oslo University Hospital
The (Norwegian) NOR Solidarity Multicenter Trial on the Efficacy of Different Anti-viral Drugs in SARS-CoV-2 Infected Patients
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
700
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Oslo, Norway, 0756
- Recruiting
- Andreas Barratt-Due
-
Contact:
- ANDREAS BARRATT-DUE, PhD
- Phone Number: +47 98209974
- Email: andreas.barrattdue@gmail.com
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Contact:
- Pål Aukrust, PhD
- Phone Number: +47 46778374
- Email: paukrust@ous-hf.no
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients, 18 years and above
- Confirmed SARS-2-CoV-2 infection by PCR
- Admitted to the hospital ward or the ICU
- Subjects (or legally authorized representative) provides written informed consent prior to initiation of the study
Exclusion Criteria:
- Severe co-morbidity with life expectancy <3 months according to investigators assessment
- (Aspartate Transaminase/ Alanine Aminotransferase) ASAT/ALAT > 5 times the upper limit of normal
- Acute co-morbidity within 7 days before inclusion such as myocardial infarction
- Known intolerance to the available study drugs
- Pregnancy, possible pregnancy or breast feeding
- Any reason why, in the opinion of the investigators, the patient should not participate
- Subject participates in a potentially confounding drug or device trial during the course of the study
- Prolonged QT interval (>450 ms)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Hydroxychloroquine
|
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.
The standard of care will be supplied to all patients not receiving a drug intervention.
|
Active Comparator: Remdesivir
|
The standard of care will be supplied to all patients not receiving a drug intervention.
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.
|
Active Comparator: Control group - SoC
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
In-hospital mortality
Time Frame: 3 weeks
|
All cause in-hospital mortality
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence and duration of mechanical ventilation
Time Frame: 3 weeks
|
3 weeks
|
Occurrence and duration of intensive care unit (ICU) treatment
Time Frame: 3 weeks
|
3 weeks
|
Duration of hospital admittance
Time Frame: 1 month
|
1 month
|
28 Day mortality
Time Frame: 3 weeks
|
3 weeks
|
Viral clearance as assessed by SARS-CoV-2 PCR in peripheral blood and nasopharyngeal airway speciemen
Time Frame: 3 weeks
|
3 weeks
|
Occurrence of co-infections
Time Frame: 3 weeks
|
3 weeks
|
Occurrence of organ dysfunction
Time Frame: 3 months
|
3 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Inflammatory and anti-inflammatory mediators as assessed in serum and plasma
Time Frame: Throughout hospitalization
|
Throughout hospitalization
|
Markers of extracellular matrix remodeling
Time Frame: Throughout hospitalization and 3 months after remission
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Throughout hospitalization and 3 months after remission
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Markers of endothelial activation
Time Frame: Throughout hospitalization
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Throughout hospitalization
|
Markers of platelet activation
Time Frame: Throughout hospitalization
|
Throughout hospitalization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Paul Aukrust, MD, Professor, Oslo University Hospital
- Principal Investigator: Andreas Barratt-Due, MD, PhD, Oslo University Hospital
- Principal Investigator: Trine Kåsine, MD, 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: Inge Christoffer Olsen, PhD, NorCRIN
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 28, 2020
Primary Completion (Anticipated)
August 1, 2020
Study Completion (Anticipated)
November 1, 2020
Study Registration Dates
First Submitted
March 23, 2020
First Submitted That Met QC Criteria
March 24, 2020
First Posted (Actual)
March 25, 2020
Study Record Updates
Last Update Posted (Actual)
April 14, 2020
Last Update Submitted That Met QC Criteria
April 10, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Infant, Newborn, Diseases
- Lung Injury
- Infant, Premature, Diseases
- Severe Acute Respiratory Syndrome
- COVID-19
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Hydroxychloroquine
- Remdesivir
Other Study ID Numbers
- 118684
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
All patients included in this study will automatically be included in the WHO COVID 19 protocol
IPD Sharing Time Frame
The study will end according the requirements to WHO
IPD Sharing Access Criteria
WHO COVID 19 investigators
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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