Clinical Study AZIQUINE-ICU
AZIQUINE-ICU will be conducted as a randomized double-blind placebo-controlled multicenter study. This type of scientific trial represents the ultimate level of testing of any hypothesis that had surged during providing medical care or during testing new drugs. Results from this kind of studies make it possible to confirm or refute the validity of utilized procedures. At the same the results are respected by the experts in the field and can, therefore, define new standards in treatment of patients. In our case, we decided to test the positive effect two broadly available drugs - azithromycin and hydroxychloroquine - could have on the progression of severe cases of COVID-19. Our goal is to find out on a sample of 250 patients, whether these drugs can really improve their state. Some could find providing sick patients with placebo unethical, others could dislike the idea of administering drugs with potential side-effects. However, this is the exact reason why this study is so important - so we can finally assess which type of treatment is the most effective one. Whether the results show that these drugs do improve the state of critically ill COVID-19 patients or not, they will help us figure out the best way to treat our patients and give them the best possible care. Our study already received authorization from the State Institute for Drug Control and the Ethical Committee.
Randomized double-blind placebo-controlled multicenter study?
We know it sounds very elaborate, but we will do our best to explain this method to you step by step.
Randomization means that patients - if they agree with it - are randomly placed into two different groups that are sufficiently large. One group is treated with the tested drug and the other is treated with placebo. Random allocation ensures that other factors that could influence the results are approximately the same in both groups. The only difference between the groups is whether the patients are given the drug or placebo.
Double-blindness is used because of the assumption that the medical team and the patient could act differently depending on the fact whether the patient is being given the tested drug or the placebo. Due to this only when the results are ready the patient and the medical team will learn which group did the patient belong to. Only when the patient and the physician do not know if the pill being administered is the drug or the placebo, the treatment will be influenced only by the drugs effect.
Multicenter study means that the trial will take place at various facilities. This enables the conductors of the trial to test the subjects of the study in a shorter period of time and, additionally, the results are more generalisable. Our study will be held in 8 centers in Prague, Brno, Plzeň and Olomouc.
Our Team and the Facilities Where the Study Will Take Place
Olga Klementová, MD, PhD Clinic of Anesthesiology, Resuscitation and Intensive Care Medicine, Faculty of Medicine Palacký University in Olomouc
a intenzivní medicíny FN a LF UP v Olomouci