SARS-COV-2 infection MedDRA version: 21.1 Level: LLT Classification code 10037373 Term: Pulmonary disorder System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Plaquenil
Product Name: Plaquenil
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: hydroxychloroquine sulphate
CAS Number: 747-36-4
Other descriptive name: HYDROXYCHLOROQUINE S
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion 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 5. No anticipated transfer within 72 hours to a non-study hospital 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 609 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 609
Exclusion criteria
Exclusion criteria: 1. Severe co-morbidity with life expectancy 5 times the upper limit of normal 3. Acute co-morbidity within 7 days before inclusion such as myocardial infarction 4. Known intolerance and hypersensitivity to any of the components of the available study drug. 5. Pregnancy or breast feeding 6. Any reason why, in the opinion of the investigators, the patient should not participate 7. Participation in a potentially confounding drug or device trial during the course of the study 8. Prolonged QTc interval (>470 ms) 9. Already receiving any of the study drugs 10. Patients with psoriasis 11. Patients on concomitant medication which is part of the list of prohibited medications have to be excluded from the current study (see protocol section 4.3)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of Remdesivir and Hydroxychloroquine on all-cause in-hospital mortality compared to standard of care. ;Secondary Objective: - To assess the effect of Remdesivir and Hydroxychloroquine treatment on hospital duration, receipt of ventilation or intensive care, and to identify any serious adverse reactions. - To assess the effect of Remdesivir and Hydroxychloroquine treatment on 28 days mortality, viral clearance, kidney and myocardial failure, co-infections, organ dysfunction and health-related Quality of Life. Exploratory: Assess the effect of Remdesivir and Hydroxychloroquine on biomarkers and safety. ;Primary end point(s): All-cause in-hospital mortality. ;Timepoint(s) of evaluation of this end point: During hospitalisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): During hospitalisation: - Receipt of mechanical ventilation - Time to first receiving and duration of mechanical ventilation - Receipt of intensive care - Duration of intensive care - Occurrence of Suspected Unexpected Serious Adverse Reactions (SUSARs) During hospitalisation: - Viral clearance as assessed by SARS-CoV 2 PCR in oropharyngeal specimens during hospitalization - Occurence of kidney failure (eGFR <40 mL/min) - Occurence of myocardial involvement assessed by biochemical markers as well as echocardiography measuring left ventricular ejection fraction within the first week - Occurence of co-infections (super infections with bacteria, fungi and other virus) Assessed after 28 days: - Overall survival - Patient reported respiratory health status by CAT (Chronic Obstructive Pulmonary Disease (COPD) assessment Test) score Assessed after 3 months: - Occurence of systolic and diastolic cardiac dysfunction and level of remodelling asssessed by echocardiography and biochemical markers - Occurence of pulmonary dysfunction and level of fibrosis assessed by spirometry and thoracic CT scan - Health related quality of life assessed by the RAND 36-item Short Form Health Survey (SF-36) item scores and the 5-dimension EuroQol (EQ-5D) questionnaires index value. Exploratory: Biomarkers during hospitalisation and after 3 months - Inflammatory and anti-inflammatory mediators as assessed in serum and plasma - Markers of extracellular matrix remodelling - Markers of endothelial activation - Markers of platelet activation - Cellular immunity - Prognostic biosignatures (RNA) - Gut microbiota assessed by rectal swab - Pharmacokinetics during hospitalization - Adverse events during hospitalization;Timepoint(s) of evaluation of this end point: Please see above | — |
Countries
Norway, Sweden
Contacts
Public ContactSect. Clin. Imm. & Infect. Diseases
Oslo university hospital
Outcome results
None listed