Clinical trial, PHASE III, randomized, open-label, to evaluate the efficacy of administering high-dose cholecalciferol orally alongside standard therapy in patients with COVID-19 pneumonia (COVID-19 HUSO). - Efficacy of high dose vitamin D in COVID-19 pneumonia

Miguel Cervero Jiménez, servicio de Medicina Interna, Hospital Universitario Severo Ochoa0 个研究点目标入组 82 人开始时间: 2020年5月31日最近更新: 2020年11月30日

试验速览

暂无简介。

•- 25-hydroxyvitamin D3 levels < 30 ng/mL
•- To agree to participate in the study by signing the informed consent.
•- Men and women aged =18 and =85.
•- Patients admitted with a diagnosis of pneumonia based on clinical-radiological criteria or confirmed by COVID-19 microbiology, who have had > 7 days of symptoms (cough or fever) and whose oxygen saturation is less than 94%.
•- Men and women with reproductive capacity should agree to use
•contraceptives in the study and within 30 days of the last visit.
•- In addition, women in the study with reproductive capacity should
•have a negative pregnancy test at the time of inclusion.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 22

•- Patients participating in any other clinical trials with drugs with potential
•antiviral action for COVID-19
•- They are already being treated with vitamin D.
•- Evidence of multiorgan failure.
•- Patients requiring mechanical ventilation at the time of inclusion.
•- Patients with hypersensitivity to the active ingredient cholecalciferol or to refined olive oil excipient
•- Patients with hypercalcemia or hypercalciuria
•- Kidney stones (nephrolithiasis, nephrocalcinosis) in patients with chronic hypercalcemia.
•- Patients with severe renal failure. (stage 4, eGF < 30)
•- Patients being treated with digoxin.
•- Patients with a diagnosis of hereditary fructose intolerance, malabsorption of glucose-galactose or sucrose insufficiency.
•- Gestation or lactation
•- Sarcoidosis
•- Hyperparathyroidism
•- Patients who for any reason should not be included in the study according to
•evaluation of the investigation team.
•- Subjects who are not capable of understanding the information sheet and unable to
•sign the informed consent.
•- Patients who are expected to be transferred to another facility within 96 hours.
•- Patients who are expected to die within the next 24-48 hours

发起方

Miguel Cervero Jiménez, servicio de Medicina Interna, Hospital Universitario Severo Ochoa