COVID-19 trials registries data warehouse

https://trialregister.nl/trial/8490

Jesper Weehuizen

j.m.weehuizen-2@umcutrecht.nl

2020-03-31

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

- Patients (=18 years of age) admitted to the hospital with confirmed COVID-19 and not needing admission to MC or ICU- Patient has moderate to severe COVID-19. This will be defined as patients with NEWS-2 score = 5. - Willing and able to give written informed consent

- Severe Covid-19 defined as NEWS-2 score >5 or admission to the ICU needing ventilation or pressure support. - Contra-indications for hydroxychloroquine or chloroquine- Known pregnancy, not using adequate contraception and having a chance of being pregnant (unless a negative pregnancy test is documented) or breast-feeding- Unable to take oral medication (chloroquine and hydroxychloroquine can be administered through tube feeding and is considered oral administration)- Identified allergies to 4-aminoquinoline- Severe diseases of the blood system - 6-phosphate dehydrogenase deficiency - History of acute myocardial infarction, unstable angina pectoris, severe arrhythmia (frequent ventricular, ventricular tachycardia, ventricular fibrillation) in recent 6 months, New York Heart Association (NYHA) level III-IV- Corrected QT interval (QTc) = 480ms on baseline electrocardiogram. (The treatment guideline states: An electrocardiogram is made before start chloroquine and hydroxychloroquine)- Uncorrected severe hypokalaemia (< 2,5 mmol/l) or uncorrected severe hypomagnesemia (< 0.6 mmol/l) - Pancreatitis- Concomitant medication that affect drug absorption, metabolism and excretion, that can induce QT interval prolongation: o Amiodarone, disopyramide, flecainide, ibutailide, kinidine, sotalol, o chlorpromazine, citolapram, escitalopram, haloperidol, pimozide, o azitromycine, claritromycine, erytromycine, moxifloxacine, trimethoprim/sulfamethoxazole, o Dimperidon, ondansetron,o Methadon, o Anagrelide, arseentrioxide, droperidol, pentamidine, sevofluraan, vandetanib. - Refusal to participate expressed by patient or legally authorized representative if they are present

2

UMC Utrecht

18

None

Netherlands

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

950

- Composite endpoint with disease progression defined as a NEWS2score = 7 within 14 days or resulting in admission to Intensive/Medium Care unit or resulting in death within 14 days.

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

Not reported

[{"arm_notes": "", "treatment_id": 279, "treatment_name": "Chloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]