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
Product Code: P01BA02
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: hydroxychloroquine sulphate
CAS Number: 747-36-4
Other descriptive name
Sponsors
Karolinska 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 provides written informed consent prior to initiation of the study 5. No anticipated transfer within 72 hours to a non-study hospital 6. • If heterosexually active, men and women of child bearing potential must practice a highly effective method of birth control, including combined (estrogen and progestogen containing) hormonal prescription oral, intravaginal, transdermal contraceptives, or progestogen containing hormonal prescription oral, injectable, implantable contraceptives or intrauterine device (IUD), or intrauterine hormone-releasing systems (IUS), or male partner sterilization. The above methods of contraception must be agreed to be used up to the last visit, Follow up 3 months. 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. Severe renal impairment, defined as an eGFR 470 ms) 10. Cardiac heart failure (Ejection Fraction < 40%; uncompensated) 11. Electrolyte disturbances as hypocalcemia <4.65 mg/dL, hypokalemia <3.4 mmol/L, or hypomagnesia <1.7 mg/dL. However, if the electrolyte disturbances are corrected patient may be included with a delayed start of the test drug 12. Patients already receiving any of the study drugs 13. Patients diagnosed with psoriasis or porphyria 14. Patients receiving any of the following medications: dexametasone, haloperidol, carbamazepine, phenytoin, rifampin, phenobarbital, isoniazid, pyrazinamide, nevirapine, ritonavir, phenytoin or sodium valproate/valproic acid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of Remdesivir and Hydroxychloroquine on allcause 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, coinfections, organ dysfunction and health-related Quality of Life. ;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 peripheral blood and nasopharyngeal and lower airway specimens during hospitalisation - Occurence of kidney failure (eGFR <40) - Occurence of myocardial failure (left ventricular ejection fraction <40 % as assessed by echocardiography) - Occurence of co-infections (super infections with bacteria, fungi and other virus) Assessed during or after 3 months: - Presence of organ dysfunction (i.e. pulmonary, renal, cardiac and cerebral) after 3 months - Quality of Life after 3 months assessed by Version 1.2 of the generic 36-item Short Form Health Survey (SF-36) and the 5-dimension EuroQoL (EQ-5D) questionnaires. - 28 days mortality Exploratory: Biomarkers during hospitalisation • Inflammatory and anti-inflammatory mediators as assessed in serum and plasma • Markers of extracellular matrix remodelling • Markers of endothelial activation Markers of platelet activation Adverse events during hospitalisation;Timepoint(s) of evaluation of this end point: Please see above | — |
Countries
Norway, Sweden
Contacts
Public ContactMedical unit for infect deseases
Karolinska University hospital
Outcome results
None listed