Clinical trial, randomized, open-label, to evaluate the efficacy of high-dose vitamin D in patients with COVID-19 pneumonia

Phase 1

• Conditions: COVID-19 PNEUMONIA; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002312-43-ES
• Lead Sponsor: Miguel Cervero Jiménez, servicio de Medicina Interna, Hospital Universitario Severo Ochoa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-31
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

- 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

Exclusion Criteria

- 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

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Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified