COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-000982-18/SE

Karolinska University hospital - Medical unit for infect deseases

soo.aleman@sll.se

2020-04-20

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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.

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.

3

Karolinska University hospital

18

100

Sweden

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

1218

All-cause in-hospital mortality.

Declared number of arm (4.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]