NORWEGIAN CORONAVIRUS DISEASE 2019 [NO-COVID-19] STUDY: A TRIAL TO EVALUATE THE ANTIVIRAL EFFECT OF CHLOROQUINE IN ADULT PATIENTS WITH SARS-COV-2 INFECTION

NORWEGIAN CORONAVIRUS DISEASE 2019 (NO COVID-19) STUDY: AN OPEN LABELED RANDOMIZED CONTROLLED PRAGMATIC TRIAL TO EVALUATE THE ANTIVIRAL EFFECT OF CHLOROQUINE IN ADULT PATIENTS WITH SARS-COV-2 INFECTION - NO-COVID-19

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001010-38-NO

Enrollment

200

Registered

2020-03-16

Start date

2020-03-23

Completion date

Unknown

Last updated

2020-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-COV-2 infection MedDRA version: 21.1 Level: LLT Classification code 10037373 Term: Pulmonary disorder System Organ Class: 100000004855

Interventions

Trade Name: Plaquenil Product Name: Plaquenil Pharmaceutical Form: Film-coated tablet INN or Proposed INN: hydroxychloroquine sulfate CAS Number: 747-36-4 Other descriptive name: HYDROXYCHLOROQUINE SU

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Hospitalised 2. Adults 18 year or older 3. Moderately severe disease (NEWS score = 6) 4. SARS-CoV-2 positive nasopharyngeal swab 5. Signed informed consent must be obtained and documented according to ICH GCP, and national/local regulations. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 160

Exclusion criteria

Exclusion criteria: 1. Requiring ICU admission at screening 2. History of psoriasis 3. Tinnitus, reduced hearing 4. Visual impairment 5. Known adverse reaction to hydroxychloroquine sulphate 6. Pregnancy 7. Prolonged QT interval (>450 ms)

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess whether early treatment with chloroquine in patients with established COVID-19 will significantly reduce replication rate of SARS-CoV-2.;Secondary Objective: • Assess the impact of early treatment with chloroquine in patients with established COVID-19 on rate of decline in SARS-CoV-2 viral load in nasopharyngeal samples as assessed by RT-PCR from baseline to 96 hours • Assess the impact of early treatment with chloroquine in patients with established COVID-19 on changes in NEWS score • Assess the impact of early treatment with chloroquine in patients with established COVID-19 on admission rate to ICU • Assess the impact of early treatment with chloroquine in patients with established COVID-19 on in hospital mortality ;Primary end point(s): Rate of decline in SARS-CoV-2 viral load in nasopharyngeal samples as assessed by RT-PCR in samples collected at baseline, 48 and 96 hours after randomization;Timepoint(s) of evaluation of this end point: 96 hours.	—

Measure

Time frame

Main Objective: To assess whether early treatment with chloroquine in patients with established COVID-19 will significantly reduce replication rate of SARS-CoV-2.;Secondary Objective: • Assess the impact of early treatment with chloroquine in patients with established COVID-19 on rate of decline in SARS-CoV-2 viral load in nasopharyngeal samples as assessed by RT-PCR from baseline to 96 hours • Assess the impact of early treatment with chloroquine in patients with established COVID-19 on changes in NEWS score • Assess the impact of early treatment with chloroquine in patients with established COVID-19 on admission rate to ICU • Assess the impact of early treatment with chloroquine in patients with established COVID-19 on in hospital mortality ;Primary end point(s): Rate of decline in SARS-CoV-2 viral load in nasopharyngeal samples as assessed by RT-PCR in samples collected at baseline, 48 and 96 hours after randomization;Timepoint(s) of evaluation of this end point: 96 hours.

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Secondary

Measure	Time frame
Secondary end point(s): • Change in NEWS score at 96 hours after randomization • Admission to ICU • In-hospital mortality • Duration of hospital admission • Mortality at 30 and 90 days • Clinical status will also be assessed by percentage of subjects reporting each severity rating on a 6-point ordinal scale 96 hours after randomization: 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 ;Timepoint(s) of evaluation of this end point: See above.	—

Measure

Time frame

Secondary end point(s): • Change in NEWS score at 96 hours after randomization • Admission to ICU • In-hospital mortality • Duration of hospital admission • Mortality at 30 and 90 days • Clinical status will also be assessed by percentage of subjects reporting each severity rating on a 6-point ordinal scale 96 hours after randomization: 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 ;Timepoint(s) of evaluation of this end point: See above.

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Countries

Norway

Contacts

Public ContactDepartment of Infectious Diseases

Akershus University Hospital

jan.erik.berdal@medisin.uio.no+4767960000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026