Investigation at Reina Sofia University Hospital in Cordoba, Spain: Calcifediol Lessened the Severity of COVID-19

Sep 28, 2020 | Calcifediol, COVID-19, News, Positive Results, Reina Sofia University Hospital, Spain

Investigation at Reina Sofia University Hospital in Cordoba Spain Calcifediol Lessened the Severity of COVID-19

A research team from Reina Sofia University Hospital in Cordoba, Spain, hypothesized that the vitamin D endocrine system could potentially direct a number of actions on cells and tissues involved in the negative progression of COVID-19 particularly by decreasing the Acute Respiratory Distress Syndrome. By designing a pilot randomized, open label, double-masked clinical trial, this team investigated the effect of a calcifediol treatment on Intensive Care Unit Admission and Mortality rate among Spanish 76 patients hospitalized for SARS-CoV-2, the virus behind COVID-19. The investigators found, based on their pilot study, that administering a high dose of Calcifediol or 25-hydroxyvitamin D, a main metabolite of vitamin D endocrine system, significantly reduced the need for ICU treatment of patients requiring hospitalization due to proven COVID-19. The team from Reina Sofia University Hospital speculate that Calcifediol appears to lessen disease severity, however they acknowledge that larger clinical trials, including groups properly matched, are in fact necessary for formal evidence or a definitive answer.

Study Treatment

Hector DeLucha’s laboratory showed that the liver was necessary for the formulation of calcifediol. In 1972, Michael F. Holick isolated the enzyme responsible for cholecalciferol 25-hydroxylase.

Calcifediol is also known as calcidiol, 25-hydroxycholecalciferol, or 25-hydroxyvitamin D (25(OH)D) and is in fact a prehormone produced in the liver by hydroxylation of vitamin D via an enzyme cholecalciferol 25-hydroxylase. Doctors worldwide measure this metabolite to assess a patient’s vitamin D status. With a standard daily consumption of vitamin D3, its full conversion to calcifediol takes about 7 days

Thus, it is then converted in the kidneys to secosteroid hormone representing an active form of vitamin D. It can also be converted into 24-hydroxycalcidiol in the kidneys via 24-hyroxylation.

Study Background

In a recent study titled Effect of calcifediol treatment and best available therapy versus best available therapy on intensive care unit admission and mortality among patients hospitalized for COVID-19: A pilot randomized clincial study,” the authors set out to design a parallel pilot randomized open label, double-masked clinical trial to investigate the hypothesis that the vitamin D endocrine system can have a variety of actions on cells and tissues involved in COVID-19 disease progression especially involving the decreasing of Acute Respiratory Distress Syndrome.

The team used calcifediol in a serum 25OHD concentration. Could this treatment have a positive impact on Intensive Care Unit Admission and Mortality rate among the Spanish patients hospitalized for COVID-19. The trial site organization was Reina Sofia University Hospital in Cordoba Spain.

Protocol

The research team shared their results recently in an online journal that all study participants received best available therapy, e.g. standard of care per the hospital protocol. The patients received a combination of hydroxychloroquine (400 mg every 12 hours on the first day, and 200 mg every 12 hours for the following 4 days), azithromycin (500 mg orally for 5 days); and eligible patients were allocated at a 2 calcifediol: 1 no calcifediol ration through electronic randomization on the day of admission to take oral calcifediol (0.532 mg) or not.

The study team reported that the subjects in the calcifediol treatment group continued with oral calcifediol (0.266 mg) on day 3 and 7, and then weekly until they were deemed ready for discharge or conversely, ICU admission. The study team measured the rate of ICU admission and deaths as examples of outcomes of effectiveness.

Results

A marked difference occurred between the calcifediol group and the standard of care cohorts. For example of those that received calcifediol, one required admission to the ICU (2%), but out of the 26 of the untreated patients, 13 needed admission (50%) p value X Fischer test p <0.001. Univariate Risk Estimate Odds Ratio for ICU in patients with Calcifediol treatment versus the standard of care group generated the following as reported by the authors online: 0.02 (95% CI 0.002-0.17). Meanwhile the Multivariate Risk Estimate Odds Ratio for ICU in patients with the investigational treatment  vs without the investigational treatment ICU (adjusting by Hypertension and T2DM): 0.03 (95%CI: 0.003-0.25).

Of those in the investigational drug cohort, no patient died and all were discharged with no complications.  Of the 13 patients admitted to the ICU and not treated with the investigational treatment, 2 died and the 11 remaining were discharged.

The team from Reina Sofia University Hospital speculate that Calcifediol appears to lessen disease severity, however they acknowledge that larger clinical trials, including groups properly matched, are in fact necessary for formal evidence or a definitive answer.

Reina Sofia University Hospital

Based in Cordoba, Spain, Reina Sofia University Hospital is a part of the Andalusia hospital system and maintains approximately 1,300 beds. The health facility was opened in 1976. It is associated with the University of Cordoba.

Lead Research/Investigator

Marta Entrenas Castillo, UGC de Neumología, Instituto Maimónides de Investigación Biomédica de Córdoba 9 (IMIBIC). Hospital Universitario Reina Sofía, Universidad de Córdoba, Avda. Menéndez 10 Pidal s/n, 14004 11, Córdoba, Spain

Luis Manuel Entrenas Costa, UGC de Neumología, Instituto Maimónides de Investigación Biomédica de Córdoba 9 (IMIBIC). Hospital Universitario Reina Sofía, Universidad de Córdoba, Avda. Menéndez 10 Pidal s/n, 14004 11, Córdoba, Spain

Jose Manuel Vaquero Barrios, UGC de Neumología, Instituto Maimónides de Investigación Biomédica de Córdoba 9 (IMIBIC). Hospital Universitario Reina Sofía, Universidad de Córdoba, Avda. Menéndez 10 Pidal s/n, 14004 11, Córdoba, Spain

Juan Francisco Alcala Diaz, Departamento de Medicina Interna. IMIBIC, CIBER de Fisiopatología de la Obesidad y la Nutrición. Hospital Universitario Reina Sofía, Universidad de Córdoba, Fundación Progreso y Salud. Avda. Menéndez Pidal s/n, 14004 14, Córdoba, Spain

Jose Lopez Miranda, Departamento de Medicina Interna. IMIBIC, CIBER de Fisiopatología de la Obesidad y la Nutrición. Hospital Universitario Reina Sofía, Universidad de Córdoba, Fundación Progreso y Salud. Avda. Menéndez Pidal s/n, 14004 14, Córdoba, Spain

Roger Bouillon, Department of Chronic Diseases, Metabolism and Ageing, Laboratory of Clinical and Experimental Endocrinology, KU Leuven, Herestraat, ON1/902, 3000, Leuven, Belgium

Jose Manuel Quesada Gomez, IMIBIC. CIBER de Fragilidad y Envejecimiento Saludable. Hospital Universitario Reina Sofía, Universidad de Córdoba, Fundación Progreso y Salud. Avda. Menéndez Pidal s/n, 18 14004, Córdoba, Spain

Note, the corresponding author is Luis Manuel Entrenas Costa, UGC de Neumología, Instituto Maimónides de Investigación Biomédica de Córdoba 9 (IMIBIC), Hospital Universitario Reina Sofía

Source: NCBI

0 Comments

Pin It on Pinterest