It is difficult to summarize the extensive and enormous clinical-assistance, teaching and research trajectory of Jose Manuel Quesada-Gomez. Honorary Professor from the University of Córdoba, doctor in Medicine and Surgery from the Faculty of Medicine of the Autonomous University of Madrid and specialist in Internal Medicine and Endocrinology and Nutrition, has developed his work in the Mineral Metabolism Unit of the Endocrinology and Nutrition Service of the complex Sanitary Cordovan and in the UCO.
It is international expert in bone metabolism and, especially, in the Endocrine System of vitamin D, metabolomics and mechanisms of action, has been the ideologue and coordinator of the revolutionary study on the use of calcifediol to combat coronavirus infection.
endocrine of vitamin D and, in particular, calcifediol, has two types of useful actions in the treatment of Covid disease. The first is to enhance the innate immunity that directly confronts SARS-2. The second is its ability to minimize the intensity of the cytokine burst, which determines the severity of the disease. Calcifediol allowed us to achieve a rapid response in serious patients, among other things, because it has a more efficient absorption mechanism than vitamin D itself. In the pilot trial, we showed that, of 50 patients treated with calcifediol, only one required admission to the ICU and none died.
From there, the multicenter clinical trial began. What results has it been throwing?
It is interesting to explain that pilot trial it was enough overwhelming and that before the start of the multicentre clinical trial, several intervention studies with calcifediol were carried out, both in other cities of Andalusia and at the Hospital del Mar in Barcelona, confirming, with a much larger sample of patients, the results of the study pilot. In relation to the multicentre clinical trial, it is currently in the phase of obtaining the results generated from the almost 600 patients recruited.
What were the most relevant challenges you encountered in the calcifediol treatment study?
The most important challenges stem from the fact that, in addition to administering calcifediol or not, the best available treatment was always established. This best treatment has varied substantially throughout the pandemic, thus introducing a great confounding factor when interpreting the results. Specifically, the use of corticosteroids as part of the treatment has had a great impact on the results, because they are of great importance in reducing the response to innate immunity and viral clearance while reducing the cytokine crisis.
Can it be said that a deficit of 25hydroxyVitamin D can alter the immune system and promote respiratory viral infections?
That was our starting point. The availability of 25-hydroxyvitamin D (calcifediol) means that, when suffering from a viral or bacterial infection, the body produces substances such as catelicidina o defensinas that defend us, worth the redundancy, from infections of these germs. Therefore, once the body is protected, our immune system is not forced to give a brutal response and not always beneficial (cytrokine crisis) in the face of the threat posed by the SARS-2 virus.
Calcifediol does not need hepatic hydroxylation, is that the key to its study?
Indeed, that is one of the keys to the acute treatment of Covid disease with calcifediol. That is, for the treatment of patients already infected and in more serious stages. Covid disease is a inflammatory disease paradigm. Inflammation in general decreases the hydroxylation capacity of the liver and therefore the activation of vitamin D.
Are there optimal values of vitamin D, calcifediol, to avoid a greater severity of Covid?
There is an interesting meta-analysis of very recent results that indicates that values of calcifediol above 50ng/ml reduce the risk of death from Covid disease to practically zero.
Is there a generalized vitamin D deficiency in the population?
Four out of every 10 inhabitants under 65 years of age, and 8 out of 10 of the population over 65 years of age, have insufficiency or deficiency. more intense in the months of winter and spring. An interesting strategy to prevent this deficiency would be the supplementation of food with vitamin Dat levels higher than those of Spanish supplements.
When the pandemic broke out, he was with another investigation to treat ulcers.
Another exciting investigation. In this case, it was the use of a purified extract obtained from the olive leaf in a hydrogel for the treatment of skin ulcers, designated EHO-85. Shortly before the outbreak of the pandemic and after nearly 10 years of basic research, we were able to carry out a trial on more than 200 patients from 23 health centers. It was exciting to see the response from the nursing community and their interest in research in this field in which they are specialists. My sincere thanks to them.
The results of the clinical trial even exceeded our expectations: our hydrogel was used for 8 weeks. As a comparator, in the control group we applied another hydrogel widely used throughout the world. Well, the average percentage of healed surface in the ulcers treated with our product doubled that obtained with that other hydrogel (79% vs 40%). These results were published in a specialized magazine last week. And most surprisingly, that difference was even more pronounced in the more chronic ulcers.
The extensive dossier of results generated allowed us to obtain, in the midst of a pandemic, authorization from the Spanish Medicines Agency for marketing. Hand in hand with the Andalusian Public Health Service, we have managed to noventurebelonging to Ferrer, has decidedly opted for its commercialization. We expect it to hit the market by the end of this year or early 2023. It was without a doubt a risky bet that we made in its day. Now it is without a doubt a successful case of transferring knowledge from the laboratory to the patient, of which I feel especially proud for having carried it out hand in hand with my son.
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