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

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002312-43-ES

Enrollment

Registered

2020-05-31

Start date

2020-05-28

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 PNEUMONIA

Interventions

Trade Name: Thorens 25000 UI Product Name: Vitamina D Product Code: A11CC05 Pharmaceutical Form: Oral solution INN or Proposed INN: Colecalciferol CAS Number: 67-97-0 Current Sponsor code: NA Other

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 25-hydroxyvitamin D3 levels 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

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 .

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this trial is to provide estimates of increased levels of 25-hydroxyvitamin D3 on days 7 and 14 after high-dose vitamin D treatment (10. 000 IU/d) Thorens@ 25000 IU single-dose vials oral solution 2.5 ml=1ml/day on admission (maximum 14 days) compared with conventional dosing (2,000 IU/d) Thorens@ 25000 IU single-dose vials oral solution 2.5 ml=0.2 ml/day on admission (maximum 14 days) ;Secondary Objective: 1.Assess the safety and tolerability of both treatment guidelines. 2. Comparison of secondary efficacy parameters between the two treatment guidelines on days 7 and 14 of treatment initiation: no progression to respiratory failure, no increased oxygen requirements; need for mechanical ventilation; reduction of analytical parameters associated with poor prognosis; radiological progression of the disease; average hospital stay; intensification treatments such as steroid boluses, Tocilizumab or Anakinra; ICU admission and % mortality at end of follow-up. 3. Evolution of the analytical parameters on the 7th and 14th days of treatment 3.1 Haematological. 3.2 Biochemicals 3.3. Phospho-calcium metabolism. 4. Immunological study: Comparison of the immunological parameters on days 7 and 14 of the beginning of the treatment of IL1b, IL2r, IL6, IL8, IL10, TNF alpha, MIP-1 alpha, CD14, GM-CSF, IFN alpha, IFN beta and IFN gamma. . ;Primary end point(s): Increased levels of 25-hydroxyvitamin D3 will be determined on days 7, and 14 after initiation of treatment;Timepoint(s) of evaluation of this end point: IT will be determined on days 7 and 14	—

Measure

Time frame

Main Objective: The aim of this trial is to provide estimates of increased levels of 25-hydroxyvitamin D3 on days 7 and 14 after high-dose vitamin D treatment (10. 000 IU/d) Thorens@ 25000 IU single-dose vials oral solution 2.5 ml=1ml/day on admission (maximum 14 days) compared with conventional dosing (2,000 IU/d) Thorens@ 25000 IU single-dose vials oral solution 2.5 ml=0.2 ml/day on admission (maximum 14 days) ;Secondary Objective: 1.Assess the safety and tolerability of both treatment guidelines. 2. Comparison of secondary efficacy parameters between the two treatment guidelines on days 7 and 14 of treatment initiation: no progression to respiratory failure, no increased oxygen requirements; need for mechanical ventilation; reduction of analytical parameters associated with poor prognosis; radiological progression of the disease; average hospital stay; intensification treatments such as steroid boluses, Tocilizumab or Anakinra; ICU admission and % mortality at end of follow-up. 3. Evolution of the analytical parameters on the 7th and 14th days of treatment 3.1 Haematological. 3.2 Biochemicals 3.3. Phospho-calcium metabolism. 4. Immunological study: Comparison of the immunological parameters on days 7 and 14 of the beginning of the treatment of IL1b, IL2r, IL6, IL8, IL10, TNF alpha, MIP-1 alpha, CD14, GM-CSF, IFN alpha, IFN beta and IFN gamma. . ;Primary end point(s): Increased levels of 25-hydroxyvitamin D3 will be determined on days 7, and 14 after initiation of treatment;Timepoint(s) of evaluation of this end point: IT will be determined on days 7 and 14

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Secondary

Measure	Time frame
Secondary end point(s): 1.Assess the safety and tolerability of both treatment guidelines. 2. Comparison of secondary efficacy parameters between the two treatment guidelines on days 7 and 14 of treatment initiation: no progression to respiratory failure, no increased oxygen requirements; need for mechanical ventilation; reduction of analytical parameters associated with poor prognosis; radiological progression of the disease; average hospital stay; intensification treatments such as steroid boluses, Tocilizumab or Anakinra, ICU admission, % mortality at end of follow-up. 3. Evolution of the analytical parameters on the 7th and 14th days of treatment 3.1 Haematological: Haemogram, differential count, D-dimer, coagulation study, fibrinogen. 3.2 Biochemicals: Renal function (creatinine, urea, and electrolytes), liver function (AST, ALT, total and fractionated bilirubin, GGT, LDH), C-reactive protein (PCR), procalcitonin (PCT), troponin, pro-BNP, CPK, albumin, total proteins, uric acid, cholesterol, triglycerides, and glucose 3.3. Phospho-calcium metabolism: calcium, PTHi, phosphorus and magnesium 4. Immunological study: Comparison of the immunological parameters on days 7 and 14 of the beginning of the treatment of IL1b, IL2r, IL6, IL8, IL10, TNF alpha, MIP-1 alpha, MIP-1 beta, CD14, GM-CSF, IFN alpha, IFN beta y IFN gamma. 5) Viral load evolution, if available. . ;Timepoint(s) of evaluation of this end point: IT will be determined on days 7 and 14	—

Measure

Time frame

Secondary end point(s): 1.Assess the safety and tolerability of both treatment guidelines. 2. Comparison of secondary efficacy parameters between the two treatment guidelines on days 7 and 14 of treatment initiation: no progression to respiratory failure, no increased oxygen requirements; need for mechanical ventilation; reduction of analytical parameters associated with poor prognosis; radiological progression of the disease; average hospital stay; intensification treatments such as steroid boluses, Tocilizumab or Anakinra, ICU admission, % mortality at end of follow-up. 3. Evolution of the analytical parameters on the 7th and 14th days of treatment 3.1 Haematological: Haemogram, differential count, D-dimer, coagulation study, fibrinogen. 3.2 Biochemicals: Renal function (creatinine, urea, and electrolytes), liver function (AST, ALT, total and fractionated bilirubin, GGT, LDH), C-reactive protein (PCR), procalcitonin (PCT), troponin, pro-BNP, CPK, albumin, total proteins, uric acid, cholesterol, triglycerides, and glucose 3.3. Phospho-calcium metabolism: calcium, PTHi, phosphorus and magnesium 4. Immunological study: Comparison of the immunological parameters on days 7 and 14 of the beginning of the treatment of IL1b, IL2r, IL6, IL8, IL10, TNF alpha, MIP-1 alpha, MIP-1 beta, CD14, GM-CSF, IFN alpha, IFN beta y IFN gamma. 5) Viral load evolution, if available. . ;Timepoint(s) of evaluation of this end point: IT will be determined on days 7 and 14

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Countries

Spain

Contacts

Public ContactMiguel Cervero

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

mcerveroj@gmail.com00349148180008338

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026