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The (Norwegian) NOR Solidarity Multicenter Trial on the Efficacy of Different Anti-viral Drugs in SARS-CoV-2 Infected Patients

Trial Profile

The (Norwegian) NOR Solidarity Multicenter Trial on the Efficacy of Different Anti-viral Drugs in SARS-CoV-2 Infected Patients

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 12 May 2020

At a glance

  • Drugs Hydroxychloroquine (Primary) ; Remdesivir (Primary)
  • Indications COVID 2019 infections; Severe acute respiratory syndrome
  • Focus Therapeutic Use
  • Acronyms N-ReCOVID 19; NOR-SOLIDARITY
  • Most Recent Events

    • 12 May 2020 Planned number of patients changed from 700 to 1218.
    • 10 Apr 2020 Status changed from not yet recruiting to recruiting.
    • 30 Mar 2020 New trial record

Trial Overview

Purpose

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.

Primary Endpoints

In-hospital mortality

description: All cause in-hospital mortality
time_frame: 3 weeks

Other Endpoints

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

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 [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Severe acute respiratory syndrome treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 1218

  • Sex male & female
  • Age Group ≥ 18 years; adult; elderly

Patient 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

Patient 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)

Trial Details

Identifiers

Identifier Owner
NCT04321616 ClinicalTrials.gov: US National Institutes of Health
EudraCT2020-000982-18 European Clinical Trials Database
118684 -
WHO-NOR-COVID19 -
NOR-SOLIDARITY -

Trial Dates

  • Initiation Dates

    Planned : 26 Mar 2020

    Actual : 28 Mar 2020

  • Primary Completion Dates

    Planned : 01 Aug 2020

  • End Dates

    Planned : 01 Nov 2020

Substudies/Extensions

POPulation PharmacoKinetic (POPPK) study of antiviral drugs in SARS-CoV-2 infected patients participating in The Investigational NOR-SOLIDARITY study. Version 6, 28 April 2020. Primary objective: To develop novel population pharmacokinetic models for Remdesivir and Hydroxychloroquine in moderate/severe COVID-19 patients. Explorative objective: Assess viral decay, CRP/ IL-6 levels, SUSARs and Grade 3 and 4 AEs, myocardial failure/ QT-time prolongation, eGFR reduction of > 50% from baseline.

Other Details

  • Design multicentre; open; parallel; prospective; randomised
  • Phase of Trial Phase II/III
  • Location Norway
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
HydroxychloroquinePrimary Drug Oral Tablet
RemdesivirPrimary Drug Intravenous Infusion

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.)

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.)

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.)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Andreas Barratt-Due, MD, PhD
0047 98209974
andreas.barrattdue@gmail.com
show details
Oslo University Hospital Norway
Anne Margarita Dyrhol Riise, MD, Professor Oslo University Hospital Norway
Inge Christoffer Olsen, PhD NorCRIN
-
Katerina Nezvalova-Henriksen, Pharm D, PhD Oslo Hospital Pharmacies
-
Marius Trøseid, MD, PhD Oslo University Hospital Norway
Paul Aukrust, MD, Professor
0047 46778374
paukrust@ous-hf.no
show details
Oslo University Hospital Norway
Pål Aukrust, PhD
+47 46778374 paukrust@ous-hf.no
show details
Andreas Barratt-Due Norway
Sect. Clin. Imm. & Infect. Diseases

Sognsvannsveien 20
Oslo
Postcode: 0372
Norway
Telephone: +4723071916
andreas.barrattdue@gmail.com
show details
Oslo University Hospital Norway
Trine Kåsine, MD Oslo University Hospital Norway

Centres

Centre Name Location Trial Centre Country
Andreas Barratt-Due Oslo Norway
NorCRIN
-
-
Oslo Hospital Pharmacies
-
-
Oslo University Hospital
-
-
Oslo University Hospital oslo Norway

Trial History

Event Date Event Type Comment
12 May 2020 Other trial event Planned number of patients changed from 700 to 1218. Updated 12 May 2020
12 May 2020 Other trial event Last checked against European Clinical Trials Database record. Updated 12 May 2020
17 Apr 2020 Other trial event New source identified and integrated European Clinical Trials Database (EudraCT2020-000982-18) Updated 17 Apr 2020
15 Apr 2020 Other trial event Last checked against Clinicaltrials.gov record. Updated 15 Apr 2020
10 Apr 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 15 Apr 2020
30 Mar 2020 New trial record New trial record Updated 30 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. European Clinical Trials Database. Trial-Reg 2016;.

    Available from: URL: https://www.clinicaltrialsregister.eu
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