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

Primary Purpose

SARS-CoV Infection, COVID 19, Acute Respiratory Distress Syndrome ARDS

Status
Unknown status
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Hydroxychloroquine
Remdesivir
(Standard of Care) SoC
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV Infection focused on measuring Effect of drugs, Adverse effects of drugs, SARS-CoV clearance, Duration of artificial ventilation, Duration of intensive care stay, Duration of hospital stay

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Andreas Barratt-DueRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Hydroxychloroquine

Remdesivir

Control group - SoC

Arm Description

Outcomes

Primary Outcome Measures

In-hospital mortality
All cause in-hospital mortality

Secondary Outcome Measures

Occurrence and duration of mechanical ventilation
Occurrence and duration of intensive care unit (ICU) treatment
Duration of hospital admittance
28 Day mortality
Viral clearance as assessed by SARS-CoV-2 PCR in peripheral blood and nasopharyngeal airway speciemen
Occurrence of co-infections
Occurrence of organ dysfunction

Full Information

First Posted
March 23, 2020
Last Updated
April 10, 2020
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04321616
Brief Title
The Efficacy of Different Anti-viral Drugs in COVID 19 Infected Patients
Official Title
The (Norwegian) NOR Solidarity Multicenter Trial on the Efficacy of Different Anti-viral Drugs in SARS-CoV-2 Infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 28, 2020 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV Infection, COVID 19, Acute Respiratory Distress Syndrome ARDS
Keywords
Effect of drugs, Adverse effects of drugs, SARS-CoV clearance, Duration of artificial ventilation, Duration of intensive care stay, Duration of hospital stay

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
An open randomized adaptive controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hydroxychloroquine
Arm Type
Active Comparator
Arm Title
Remdesivir
Arm Type
Active Comparator
Arm Title
Control group - SoC
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Remdesivir
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
(Standard of Care) SoC
Intervention Description
The standard of care will be supplied to all patients not receiving a drug intervention.
Primary Outcome Measure Information:
Title
In-hospital mortality
Description
All cause in-hospital mortality
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Occurrence and duration of mechanical ventilation
Time Frame
3 weeks
Title
Occurrence and duration of intensive care unit (ICU) treatment
Time Frame
3 weeks
Title
Duration of hospital admittance
Time Frame
1 month
Title
28 Day mortality
Time Frame
3 weeks
Title
Viral clearance as assessed by SARS-CoV-2 PCR in peripheral blood and nasopharyngeal airway speciemen
Time Frame
3 weeks
Title
Occurrence of co-infections
Time Frame
3 weeks
Title
Occurrence of organ dysfunction
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Inflammatory and anti-inflammatory mediators as assessed in serum and plasma
Time Frame
Throughout hospitalization
Title
Markers of extracellular matrix remodeling
Time Frame
Throughout hospitalization and 3 months after remission
Title
Markers of endothelial activation
Time Frame
Throughout hospitalization
Title
Markers of platelet activation
Time Frame
Throughout hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Aukrust, MD, Professor
Phone
0047 46778374
Email
paukrust@ous-hf.no
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Barratt-Due, MD, PhD
Phone
0047 98209974
Email
andreas.barrattdue@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Aukrust, MD, Professor
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andreas Barratt-Due, MD, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Trine Kåsine, MD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katerina Nezvalova-Henriksen, Pharm D, PhD
Organizational Affiliation
Oslo Hospital Pharmacies
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne Margarita Dyrhol Riise, MD, Professor
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marius Trøseid, MD, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Inge Christoffer Olsen, PhD
Organizational Affiliation
NorCRIN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Andreas Barratt-Due
City
Oslo
ZIP/Postal Code
0756
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANDREAS BARRATT-DUE, PhD
Phone
+47 98209974
Email
andreas.barrattdue@gmail.com
First Name & Middle Initial & Last Name & Degree
Pål Aukrust, PhD
Phone
+47 46778374
Email
paukrust@ous-hf.no

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
34350582
Citation
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.
Results Reference
derived
PubMed Identifier
34251903
Citation
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.
Results Reference
derived

Learn more about this trial

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

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