The Efficacy of Different Anti-viral Drugs in COVID 19 Infected Patients
Status:
Recruiting
Sponsors
Oslo University Hospital
Abstract:
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.
Condition or disease:SARS-CoV Infection
COVID 19
Acute Respiratory Distress Syndrome ARDS
Intervention/treatment:
Drug:
Drug:
Other:
Phase:Phase 2/Phase 3
Study design:
Study Type:Interventional
Allocation:Randomized
:An open randomized adaptive controlled trial
Primary Purpose:Treatment
Masking:None (Open Label)
Arm group:
ArmIntervention/treatment
Active Comparator: Hydroxychloroquine
Active Comparator: Remdesivir
Active Comparator: Control group - SoC
Eligibility Criteria:
Ages Eligible for Study:18 Years to 18 Years
Sexes Eligible for Study:All
Accepts Healthy Volunteers:Yes
Criteria:

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)

Outcome:
Primary Outcome Measures
1. In-hospital mortality [3 weeks]
All cause in-hospital mortality
Secondary Outcome Measures
1. Occurrence and duration of mechanical ventilation [3 weeks]
2. Occurrence and duration of intensive care unit (ICU) treatment [3 weeks]
3. Duration of hospital admittance [1 month]
4. 28 Day mortality [3 weeks]
5. Viral clearance as assessed by SARS-CoV-2 PCR in peripheral blood and nasopharyngeal airway speciemen [3 weeks]
6. Occurrence of co-infections [3 weeks]
7. Occurrence of organ dysfunction [3 months]
Other Outcome Measures
1. Inflammatory and anti-inflammatory mediators as assessed in serum and plasma [Throughout hospitalization]
2. Markers of extracellular matrix remodeling [Throughout hospitalization and 3 months after remission]
3. Markers of endothelial activation [Throughout hospitalization]
4. Markers of platelet activation [Throughout hospitalization]
Relations:
Diseases
(4)
Drugs
(1)
Genes
(1)
Organisms
(2)
Affiliates
(2)
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