The NOR-SWE Solidarity multicenter trial on the efficacy of different anti-viral drugs in SARS-CoV-2 infected patients. - S-ReCOVID 19

Karolinska University hospital0 个研究点目标入组 1,218 人开始时间: 2020年4月20日最近更新: 2021年1月18日

适应症

试验速览

暂无简介。

•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

•1.Severe co-morbidity with life expectancy <3 months according to investigators assessment
•2.ASAT/ALAT > 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 <40 mL/min
•5.Known intolerance to the available study drugs
•6.Pregnancy or breast feeding
•7.Any reason why, in the opinion of the investigators, the patient should not participate
•8.Subject participates in a potentially confounding drug or device trial during the course of the study
•9.Prolonged QTc interval (>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.

发起方

Karolinska University hospital