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The Efficacy of Different Anti-viral Drugs in COVID 19 Infected Patients

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04321616
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Andreas Barratt-Due, Oslo University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
SARS-CoV Infection COVID 19 Acute Respiratory Distress Syndrome ARDS Drug: Hydroxychloroquine Drug: Remdesivir Other: (Standard of Care) SoC Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An open randomized adaptive controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The (Norwegian) NOR Solidarity Multicenter Trial on the Efficacy of Different Anti-viral Drugs in SARS-CoV-2 Infected Patients
Actual Study Start Date : March 28, 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : November 2020


Arm Intervention/treatment
Active Comparator: Hydroxychloroquine Drug: Remdesivir
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.

Other: (Standard of Care) SoC
The standard of care will be supplied to all patients not receiving a drug intervention.

Active Comparator: Remdesivir Drug: Hydroxychloroquine
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.

Other: (Standard of Care) SoC
The standard of care will be supplied to all patients not receiving a drug intervention.

Active Comparator: Control group - SoC Drug: Hydroxychloroquine
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.

Drug: Remdesivir
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.




Primary Outcome Measures :
  1. In-hospital mortality [ Time Frame: 3 weeks ]
    All cause in-hospital mortality


Secondary Outcome Measures :
  1. Occurrence and duration of mechanical ventilation [ Time Frame: 3 weeks ]
  2. Occurrence and duration of intensive care unit (ICU) treatment [ Time Frame: 3 weeks ]
  3. Duration of hospital admittance [ Time Frame: 1 month ]
  4. 28 Day mortality [ Time Frame: 3 weeks ]
  5. Viral clearance as assessed by SARS-CoV-2 PCR in peripheral blood and nasopharyngeal airway speciemen [ Time Frame: 3 weeks ]
  6. Occurrence of co-infections [ Time Frame: 3 weeks ]
  7. Occurrence of organ dysfunction [ Time Frame: 3 months ]

Other Outcome Measures:
  1. Inflammatory and anti-inflammatory mediators as assessed in serum and plasma [ Time Frame: Throughout hospitalization ]
  2. Markers of extracellular matrix remodeling [ Time Frame: Throughout hospitalization and 3 months after remission ]
  3. Markers of endothelial activation [ Time Frame: Throughout hospitalization ]
  4. Markers of platelet activation [ Time Frame: Throughout hospitalization ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients, 18 years and above
  2. Confirmed SARS-2-CoV-2 infection by PCR
  3. Admitted to the hospital ward or the ICU
  4. Subjects (or legally authorized representative) provides written informed consent prior to initiation of the study

Exclusion Criteria:

  1. Severe co-morbidity with life expectancy <3 months according to investigators assessment
  2. (Aspartate Transaminase/ Alanine Aminotransferase) ASAT/ALAT > 5 times the upper limit of normal
  3. Acute co-morbidity within 7 days before inclusion such as myocardial infarction
  4. Known intolerance to the available study drugs
  5. Pregnancy, possible pregnancy or breast feeding
  6. Any reason why, in the opinion of the investigators, the patient should not participate
  7. Subject participates in a potentially confounding drug or device trial during the course of the study
  8. Prolonged QT interval (>450 ms)

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): NCT04321616


Contacts
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Contact: Paul Aukrust, MD, Professor 0047 46778374 paukrust@ous-hf.no
Contact: Andreas Barratt-Due, MD, PhD 0047 98209974 andreas.barrattdue@gmail.com

Locations
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Norway
Andreas Barratt-Due Recruiting
Oslo, Norway, 0756
Contact: ANDREAS BARRATT-DUE, PhD    +47 98209974    andreas.barrattdue@gmail.com   
Contact: Pål Aukrust, PhD    +47 46778374    paukrust@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Investigators
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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: Marius Trøseid, MD, PhD Oslo University Hospital
Principal Investigator: Inge Christoffer Olsen, PhD NorCRIN
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Responsible Party: Andreas Barratt-Due, Principal investigator, MD, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04321616    
Other Study ID Numbers: 118684
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All patients included in this study will automatically be included in the WHO COVID 19 protocol
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: The study will end according the requirements to WHO
Access Criteria: WHO COVID 19 investigators

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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 Andreas Barratt-Due, Oslo University Hospital:
Effect of drugs
Adverse effects of drugs
SARS-CoV clearance
Duration of artificial ventilation
Duration of intensive care stay
Duration of hospital stay
Additional relevant MeSH terms:
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Coronavirus Infections
Hydroxychloroquine
Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents