Prevention and treatment with Calcifediol of respiratory problems caused by COVID-19

Prevention and treatment with Calcifediol of Coronavirus COVID-19-induced acute respiratory syndrome (SARS)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001717-20-ES

Enrollment

1008

Registered

2020-04-27

Start date

2020-04-20

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Severe Acute Respiratory Syndrome in subjects with COVID-19 MedDRA version: 20.0 Level: LLT Classification code 10061986 Term: SARS System Organ Class: 10021881 - Infections and infestations MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Hidroferol 0,266 mg cápsulas blandas Pharmaceutical Form: Capsule, soft INN or Proposed INN: CALCIFEDIOL CAS Number: 19356-17-3 Concentration unit: mg milligram(s) Concentration type: equa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 700

Exclusion criteria

Exclusion criteria: 1. Being on treatment with Calcifediol or Colecalciferol in any of its presentations and dosage 2. Intolerance or allergy to Calcifediol or its components 3. Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate that in patients =18 and <90 years, positive for coronavirus, newly hospitalized with or without oxygen respiratory support, conventional or non-invasive ventilation (BIPAP type), treatment with Calcifediol will decrease the need for ventilation invasive and admissions to the Intensive Care Unit and deaths;Secondary Objective: - To assess if the treatment in newly hospitalized patients with non-invasive ventilation will decrease the time at discharge - To evaluate in patients who require invasive ventilation and ICU admission during the process, if the treatment will decrease the number of days until the withdrawal of invasive ventilation and if it will decrease the time (in days) upon discharge from the ICU - To assess if the treatment improves the clinical evolution - To evaluate if the treatment improves the evolution of hematimetry & biochemistry parameters - To assess if the treatment decreases the markers of inflammation - To confirm that low serum 25OHD levels have a role in the negative evolution of patients to SARS - To evaluate improvement in the O2/FiO2 Saturation ratio, improvement in the degree of dyspnea according to the Borg analog scale, improvement of radiological findings by simple radiology, improvement in transcutaneous O2 saturation and potential side effects of treatment;Primary end point(s): 1) Admission to the Intensive Care Unit or 2) Death;Timepoint(s) of evaluation of this end point: Daily throughout the subject duration in the trial.	—

Measure

Time frame

Main Objective: To demonstrate that in patients =18 and <90 years, positive for coronavirus, newly hospitalized with or without oxygen respiratory support, conventional or non-invasive ventilation (BIPAP type), treatment with Calcifediol will decrease the need for ventilation invasive and admissions to the Intensive Care Unit and deaths;Secondary Objective: - To assess if the treatment in newly hospitalized patients with non-invasive ventilation will decrease the time at discharge - To evaluate in patients who require invasive ventilation and ICU admission during the process, if the treatment will decrease the number of days until the withdrawal of invasive ventilation and if it will decrease the time (in days) upon discharge from the ICU - To assess if the treatment improves the clinical evolution - To evaluate if the treatment improves the evolution of hematimetry & biochemistry parameters - To assess if the treatment decreases the markers of inflammation - To confirm that low serum 25OHD levels have a role in the negative evolution of patients to SARS - To evaluate improvement in the O2/FiO2 Saturation ratio, improvement in the degree of dyspnea according to the Borg analog scale, improvement of radiological findings by simple radiology, improvement in transcutaneous O2 saturation and potential side effects of treatment;Primary end point(s): 1) Admission to the Intensive Care Unit or 2) Death;Timepoint(s) of evaluation of this end point: Daily throughout the subject duration in the trial.

—

Secondary

Measure	Time frame
Secondary end point(s): CLINICAL EVOLUTION 1) Time from the onset of symptoms to discharge of patients in conventional hospitalization. 2) In patients who in the course of evolution required admission with mechanical ventilation in the ICU: to. Time until admission to the Intensive Care Unit b. Time until mechanical ventilation is removed c. ICU registration 3) Collection of clinical evolution data in all patients (“Check list of the disease”) on days 0, 3, 7, 14 and 21 and 28. BLOOD ANALYTICS 1) Collection of hematimetry and biochemistry data (“Check list of the disease”) in all patients, including RCT and Ca / Cr analysis on days 0, 3, 7, 14, 21 and 28 2) [SUB-STUDY] 50 aliquots of 2 cc for quantification will be collected in 50 patients (25 randomized from each group) for quantification on days 0, 3, 7, 14, 21 and 28 days: a) Disease-related inflammation markers IL 1ß, IL-2, IL-4, IL-5, IL-6, IL-8, IL-12, IL118, 1L32, tumor necrosis factor (TNF) a, interferon -?, macrophage granulocyte colony stimulating factor- (GMCSF) and chemokines: CCL2, CCL3, CCL5, CXCL8, CXCL9; b) Vitamin D metabolites (25 OHD, 1,25 (OH) D and 24,25 (OH) 2D3 ratio of 25OHD / 24,25 (OH) 2D, [system catabolism marker] c) Córdoba will study the evolution of viral load, if available. RESPIRATORY PARAMETERS, OXYGEN THERAPY, AND RESPIRATORY SUPPORT 1) Respiratory rate and SatO2, evaluated at baseline and on days 3, 7, 14, 21 and 28 2) O2 / FiO2 saturation ratio: the average of three evaluations of said ratio will be taken into account with a time interval of at least 6 hours, before and after the administration of Calcifediol at 24 hours, at 3 days, at 7 days , at 14 days and at 28 days. 3) Evaluate degree of dyspnea at 0 3, 7, 14 days with the Borg analog scale. 4) Level of consciousness, assessed at baseline and on days 3, 7, 14, 21 and 28 5) Applied oxygen (FiO2) evaluated at baseline and on days 3, 7, 14, 21 and 28 - Time until the absence of oxygen need, at least for 48 hours to maintain a	—

Measure

Time frame

Secondary end point(s): CLINICAL EVOLUTION 1) Time from the onset of symptoms to discharge of patients in conventional hospitalization. 2) In patients who in the course of evolution required admission with mechanical ventilation in the ICU: to. Time until admission to the Intensive Care Unit b. Time until mechanical ventilation is removed c. ICU registration 3) Collection of clinical evolution data in all patients (“Check list of the disease”) on days 0, 3, 7, 14 and 21 and 28. BLOOD ANALYTICS 1) Collection of hematimetry and biochemistry data (“Check list of the disease”) in all patients, including RCT and Ca / Cr analysis on days 0, 3, 7, 14, 21 and 28 2) [SUB-STUDY] 50 aliquots of 2 cc for quantification will be collected in 50 patients (25 randomized from each group) for quantification on days 0, 3, 7, 14, 21 and 28 days: a) Disease-related inflammation markers IL 1ß, IL-2, IL-4, IL-5, IL-6, IL-8, IL-12, IL118, 1L32, tumor necrosis factor (TNF) a, interferon -?, macrophage granulocyte colony stimulating factor- (GMCSF) and chemokines: CCL2, CCL3, CCL5, CXCL8, CXCL9; b) Vitamin D metabolites (25 OHD, 1,25 (OH) D and 24,25 (OH) 2D3 ratio of 25OHD / 24,25 (OH) 2D, [system catabolism marker] c) Córdoba will study the evolution of viral load, if available. RESPIRATORY PARAMETERS, OXYGEN THERAPY, AND RESPIRATORY SUPPORT 1) Respiratory rate and SatO2, evaluated at baseline and on days 3, 7, 14, 21 and 28 2) O2 / FiO2 saturation ratio: the average of three evaluations of said ratio will be taken into account with a time interval of at least 6 hours, before and after the administration of Calcifediol at 24 hours, at 3 days, at 7 days , at 14 days and at 28 days. 3) Evaluate degree of dyspnea at 0 3, 7, 14 days with the Borg analog scale. 4) Level of consciousness, assessed at baseline and on days 3, 7, 14, 21 and 28 5) Applied oxygen (FiO2) evaluated at baseline and on days 3, 7, 14, 21 and 28 - Time until the absence of oxygen need, at least for 48 hours to maintain a

—

Countries

Spain

Contacts

Public ContactAntonio Luque

Fundación para la Investigación Biomédica de Córdoba

uicec@imibic.org0034671596070

Outcome results

None listed

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