What is the clinical study AZIQUINE-ICU about and why is it important?
The pandemic of the new coronavirus COVID-19 is a challenge for the medical environment for multiple reasons. One of them is the fact that the infection spreads quickly throughout the population. In addition, a large percentage of patients experience severe symptoms and, therefore, need intensive care including mechanical ventilation of the lungs.
Unfortunately, currently there is no cure that would be verified by the standardized methodology of evidence based medicine. medicíny založené na důkazech (evidence based medicine). Our study's objective is to verify the efficiency of two drugs that are commonly available using the method that is the most accurate in clinical practice - a randomized double-blind placebo-controlled multicentre study.
The best scientific research centers worldwide are working on developing new drugs and vaccines against the virus that will surely prove to be fundamental in the future. However, it cannot be assumed that these remedies will be available for the current wave of COVID-19 infections.
On the other hand, there exists a well-founded hypothesis stating that the progression of the COVID-19 disease could be influenced by drugs that are already registered in the Czech Republic but until now were used for treating different illnesses. The drugs which could potentially be used for treatment of COVID-19 and which proved to inhibit the reproduction of the virus in a test tube (in vitro) are hydroxychloroquine, an antimalarial, and azithromycin, an antibiotic. Nevertheless, these drugs may have side effects and their impact on fighting the virus in infected patients still has not been convincingly proven.
In concordance with the current knowledge regarding these drugs, we must accept that they may help the infected patients, but also they might not work as desired and could even cause harm due to their side effects. The opinions of experts differ - some strictly reject them, others use them as treatment for all their COVID-19 patients.
Mere observation of the patients' medical states with and without the drugs (as it is nowadays done) is not the best way to asses if the treatment works and whether it is safe. The condition of a patient is influenced by many other factors - for example by additional diseases, other introduced drugs, the level of care provided by the healthcare facility where the patient is treated and many other factors that may contribute to bias concerning the drugs' effects.
Introduction by the Study Founder
Why don't we find a different way to get the money we need?
Scientific projects like this one are usually funded from so-called grants which are sums of public money managed by grant agencies and in order to be eligible for this type of financial aid, one must win in an open competition. This process usually takes 6 to 9 months. Unfortunately, in this specific situation we do not have this much time. We have addressed grant agencies, experts in the field and the Ministry of Health and we have been lucky enough to obtain funding from the grant agency of the Charles University. However, the amount of money we received is not big enough to cover all of the costs - especially because we are planning to use expensive tests to evaluate the drug levels in the patients' blood which all alone cost 42 000 EUR (circa 1 140 000 CZK). Considering that in the foreseeable future we cannot count on funding from official institutions, getting financial support from the public is the best and fastest way for us to receive the money we need in order to conduct this study.
What do we need the money for?
Randomized controlled trials, like the one we want to work on, are under normal circumstances very expensive, mostly due to their time-consuming nature. Thanks to the fact that that all the physicians participating in the study decided to renounce their claim for any financial compensation for their work the costs considerably decreased.Also the drugs have been provided for free by the company Zentiva and the IT specialist programming the electronic recording system for patients and the experts monitoring data gave up their reward too. We thank all of them from the bottom of our hearts. However, some expenses still must be paid.
Insurance for patients participating in the study that is required by law and costs hundreds of thousands of CZK, expenses linked to specialized examinations of patients needed for detailed monitoring, safety equipment for the staff and blood-sample testing and transportation charges are some of them.
The collection of data, paperwork and preparation of medication at busy facilities will be provided by specially trained staff. Their standard labour costs must be defrayed and, if the circumstances will allow us to do so, we would like to at least symbolically reward them for their hard work.
If any part of the financial aid remains unutilized, it will be used to support intensive care medicine accordingly to the Statute of the Trust Fund - preferentially to finance projects dedicated to fighting against the infection COVID-19.
Possibilities of Financial Support
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