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

Overview

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.

Full Title of Study: “The (Norwegian) NOR Solidarity Multicenter Trial on the Efficacy of Different Anti-viral Drugs in SARS-CoV-2 Infected Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2020

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Hydroxychloroquine
  • Active Comparator: Remdesivir
  • Active Comparator: Control group – SoC

Clinical Trial Outcome Measures

Primary Measures

  • In-hospital mortality
    • Time Frame: 3 weeks
    • All cause in-hospital mortality

Secondary Measures

  • 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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oslo University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Andreas Barratt-Due, Principal investigator, MD, PhD – Oslo University Hospital
  • Overall Official(s)
    • Paul Aukrust, MD, Professor, Study Chair, Oslo University Hospital
    • Andreas Barratt-Due, MD, PhD, Principal Investigator, Oslo University Hospital
    • Trine Kåsine, MD, Principal Investigator, Oslo University Hospital
    • Katerina Nezvalova-Henriksen, Pharm D, PhD, Principal Investigator, Oslo Hospital Pharmacies
    • Anne Margarita Dyrhol Riise, MD, Professor, Principal Investigator, Oslo University Hospital
    • Marius Trøseid, MD, PhD, Principal Investigator, Oslo University Hospital
    • Inge Christoffer Olsen, PhD, Principal Investigator, NorCRIN
  • Overall Contact(s)
    • Paul Aukrust, MD, Professor, 0047 46778374, paukrust@ous-hf.no

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