Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Norwegian Coronavirus Disease 2019 Study (NO COVID-19)

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: NCT04316377
Recruitment Status : Recruiting
First Posted : March 20, 2020
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Olav Dalgard, University Hospital, Akershus

Brief Summary:
In the current proposal, the investigators aim to investigate the virological and clinical effects of chloroquine treatment in patients with established COVID-19 in need of hospital admission. Patients will be randomized in a 1:1 fashion to standard of care or standard of care with the addition of therapy with chloroquine.

Condition or disease Intervention/treatment Phase
Corona Virus Infection Drug: Hydroxychloroquine Sulfate Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-arm, open label, pragmatic randomized controlled trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Norwegian Coronavirus Disease 2019 Study: An Open Labeled Randomized Controlled Pragmatic Trial to Evaluate the Antiviral Effect of Chloroquine in Adult Patients With SARS-CoV-2 Infection
Actual Study Start Date : March 25, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : March 3, 2025


Arm Intervention/treatment
Active Comparator: Treatment
Chloroquine therapy in addition to standard of care
Drug: Hydroxychloroquine Sulfate
400 mg hydroxychloroquine sulphate (equalling 310 mg base) twice daily for seven days
Other Name: Plaquenil

No Intervention: No Treatment
Standard of care



Primary Outcome Measures :
  1. Rate of decline in SARS-CoV-2 viral load [ Time Frame: Baseline (at randomization) and at 96 hours ]
    Viral load assessed by real time polymerase chain reaction in nasopharyngeal samples


Secondary Outcome Measures :
  1. Change in National Early Warning Score score [ Time Frame: Baseline (at randomization) and at 96 hours ]
    National Early Warning Score score determines the degree of illness of a patient. Scores range from 0-20, with a higher score representing further removal from normal physiology and a higher risk of morbidity and mortality.

  2. Admission to intensive care unit [ Time Frame: At all times after randomization during index admission (between admission and discharge, approximately 21 days) ]
    Transfer from regular ward to intensive care unit during index admission

  3. In-hospital mortality [ Time Frame: At all times after randomization during index admission (between admission and discharge, approximately 21 days) ]
    All-cause mortality during index admission

  4. Duration of hospital admission [ Time Frame: During index admission (between admission and discharge, approximately 21 days) ]
    Total days admitted to the hospital (difference between admission date and discharge date of index admission)

  5. Mortality at 30 and 90 days [ Time Frame: At follow-up 30 and 90 days ]
    All-cause mortality assessed at 30 and 90 days

  6. Clinical status [ Time Frame: 14 days after randomization ]

    Percentage of subjects reporting each severity rating on a 6-point ordinal scale:

    1. Death
    2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation
    3. Hospitalized, on non-invasive ventilation or high flow oxygen devices
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, not requiring supplemental oxygen
    6. Not hospitalized



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Hospitalised
  • Adults 18 year or older
  • Moderately severe disease (NEWS score ≤ 6)
  • SARS-CoV-2 positive nasopharyngeal swab
  • Signed informed consent must be obtained and documented according to ICH GCP, and national/local regulations.

Exclusion Criteria:

  • Requiring ICU admission at screening
  • History of psoriasis
  • Tinnitus, reduced hearing
  • Visual impairment

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): NCT04316377


Contacts
Layout table for location contacts
Contact: Olav Dalgard, MD PhD +47 92616800 odalgard@uio.no

Locations
Layout table for location information
Norway
Akershus University Hospital Recruiting
Lørenskog, Norway, 1478
Contact: Olav Dalgard, MD PhD    +47 92 61 68 00    odalgard@uio.no   
Sponsors and Collaborators
University Hospital, Akershus
Investigators
Layout table for investigator information
Principal Investigator: Olav Dalgard, MD PhD Akerhus University Hospital

Layout table for additonal information
Responsible Party: Olav Dalgard, Professor, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT04316377    
Other Study ID Numbers: REC 121446
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Olav Dalgard, University Hospital, Akershus:
Corona virus infection
Chloroquine
Pragmatic trial
Additional relevant MeSH terms:
Layout table for MeSH terms
Chloroquine
Chloroquine diphosphate
Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Amebicides
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics