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

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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

Tracking Information
First Submitted Date  ICMJE March 23, 2020
First Posted Date  ICMJE March 25, 2020
Last Update Posted Date April 14, 2020
Actual Study Start Date  ICMJE March 28, 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2020)
In-hospital mortality [ Time Frame: 3 weeks ]
All cause in-hospital mortality
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2020)
  • Occurrence and duration of mechanical ventilation [ Time Frame: 3 weeks ]
  • Occurrence and duration of intensive care unit (ICU) treatment [ Time Frame: 3 weeks ]
  • Duration of hospital admittance [ Time Frame: 1 month ]
  • 28 Day mortality [ Time Frame: 3 weeks ]
  • Viral clearance as assessed by SARS-CoV-2 PCR in peripheral blood and nasopharyngeal airway speciemen [ Time Frame: 3 weeks ]
  • Occurrence of co-infections [ Time Frame: 3 weeks ]
  • Occurrence of organ dysfunction [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 24, 2020)
  • Inflammatory and anti-inflammatory mediators as assessed in serum and plasma [ Time Frame: Throughout hospitalization ]
  • Markers of extracellular matrix remodeling [ Time Frame: Throughout hospitalization and 3 months after remission ]
  • Markers of endothelial activation [ Time Frame: Throughout hospitalization ]
  • Markers of platelet activation [ Time Frame: Throughout hospitalization ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Different Anti-viral Drugs in COVID 19 Infected Patients
Official Title  ICMJE The (Norwegian) NOR Solidarity Multicenter Trial on the Efficacy of Different Anti-viral Drugs in SARS-CoV-2 Infected Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
An open randomized adaptive controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • SARS-CoV Infection
  • COVID 19
  • Acute Respiratory Distress Syndrome ARDS
Intervention  ICMJE
  • 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.
  • Other: (Standard of Care) SoC
    The standard of care will be supplied to all patients not receiving a drug intervention.
Study Arms  ICMJE
  • Active Comparator: Hydroxychloroquine
    Interventions:
    • Drug: Remdesivir
    • Other: (Standard of Care) SoC
  • Active Comparator: Remdesivir
    Interventions:
    • Drug: Hydroxychloroquine
    • Other: (Standard of Care) SoC
  • Active Comparator: Control group - SoC
    Interventions:
    • Drug: Hydroxychloroquine
    • Drug: Remdesivir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 24, 2020)
700
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Paul Aukrust, MD, Professor 0047 46778374 paukrust@ous-hf.no
Contact: Andreas Barratt-Due, MD, PhD 0047 98209974 andreas.barrattdue@gmail.com
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04321616
Other Study ID Numbers  ICMJE 118684
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: The study will end according the requirements to WHO
Access Criteria: WHO COVID 19 investigators
Responsible Party Andreas Barratt-Due, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Oslo University Hospital
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP