search
Back to results

Prevention and Treatment With Calcifediol of COVID-19 Induced Acute Respiratory Syndrome (COVIDIOL)

Primary Purpose

SARS-CoV 2, COVID19, SARS (Severe Acute Respiratory Syndrome)

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
BAT + Calcifediol
BAT
Sponsored by
Maimónides Biomedical Research Institute of Córdoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV 2

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 and < 90 years
  • PCR confirmed diagnosis of COVID-19. As an alternative to PCR, a determination of antigens or any other test that in the future is considered equivalent to these in its diagnostic value may be accepted as evidence
  • Radiological image compatible with inflammatory pleuropulmonary exudate or patients with onset of symptoms in the last 7 days and with an uncomplicated respiratory infection for outpatient follow-up.
  • Signature of direct or delegated informed consent

Exclusion Criteria:

  • Being treated with Calcifediol or Cholecalciferol in any of its presentations and dosages
  • Intolerance or allergy to Calcifediol or its components
  • Pregnancy

Sites / Locations

  • Hospital Universitario Reina Sofía

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control - best available therapy

Treatment

Arm Description

The subject will be treated with the best available therapy, which will include any combination of drugs included in the current protocol of the Ministry of Health and/or complementary notes issued by the Spanish Agency of Medicines and Health Products (AEMPS).

The subject will be treated with the best available therapy, which will include any combination of drugs included in the current protocol of the Ministry of Health and/or complementary notes issued by the Spanish Agency of Medicines and Health Products (AEMPS) plus Calcifediol caps. 266 µg. According to the pharmacokinetics of Calcifediol evaluated in an inflammatory model, the posology will be Start: 2 capsules Days 3, 7, 14, 21, 28: 1 capsule

Outcomes

Primary Outcome Measures

Admission to Intensive Care Unit
Proportion of subjects who enter the Intensive Care Unit
Death
Proportion of subjects who die.

Secondary Outcome Measures

Time from onset of symptoms to discharge of patients in conventional hospitalization
Compare the time (in days) at discharge in newly hospitalized patients on non-invasive ventilation.
ICU - Time until admission
In patients who, in the course of their evolution, required admission with mechanical ventilation in the ICU, time until admission to Intensive Care Unit
ICU - Time mechanical ventilation is removed
In patients who, in the course of their evolution, required admission with mechanical ventilation in the ICU, time until mechanical ventilation is removed.
Evaluation of the inflammatory markers related with the disease
Evaluation of the inflammatory markers related to IL disease. Blood samples will be collected and assessed in order to evaluate interleukins related with the interleukin storm using immunological tests.
Vitamin D metabolites
Evaluation of the Vitamin D metabolites.
Evolution in SatO2
Compare the evolution in SatO2
Evolution in the Sat O2/FiO2 ratio.
Compare the evolution in the Sat O2/FiO2 ratio
Evolution in the degree of dyspnea
Compare the evolution in the degree of dyspnea using the analog Borg scale
Evolution of the improvement of radiological findings by simple radiology
Compare the evolution of radiological findings by simple radiology in the recruited subjects since their beginning in the trial until they end the trial
Incidence of adverse events
Incidence of adverse events related to medication and its administration.
Appearance of hemorrhagic or thrombotic phenomena
Incidence in the appearance of hemorrhagic or thrombotic phenomena.

Full Information

First Posted
April 25, 2020
Last Updated
March 2, 2023
Sponsor
Maimónides Biomedical Research Institute of Córdoba
Collaborators
Junta de Andalucía - Consejería de Salud y Familias, Spain, Dynamic Solutions, Faes Farma, S.A.
search

1. Study Identification

Unique Protocol Identification Number
NCT04366908
Brief Title
Prevention and Treatment With Calcifediol of COVID-19 Induced Acute Respiratory Syndrome
Acronym
COVIDIOL
Official Title
Prevention and Treatment With Calcifediol of COVID-19 Coronavirus-induced Acute Respiratory Syndrome (SARS)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 7, 2020 (Actual)
Primary Completion Date
April 19, 2022 (Actual)
Study Completion Date
April 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maimónides Biomedical Research Institute of Córdoba
Collaborators
Junta de Andalucía - Consejería de Salud y Familias, Spain, Dynamic Solutions, Faes Farma, S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The administration of Calcifediol in patients with COVID-19, will reduce the development of SARS and the worsening of the various phases of the syndrome. Reducing at least 25% in ICU admission and death from the process, reducing days of hospitalization, facilitating the recovery of the same, acting significantly and positively, in any of its phases throughout the natural history of illness. As a treatment with extensive experience of clinical use, safe, inexpensive, and potentially very effective, it will have a highly efficient cost-benefit impact on the prevention of SARS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV 2, COVID19, SARS (Severe Acute Respiratory Syndrome), Cytokine Release Syndrome, Cytokine Storm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
517 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control - best available therapy
Arm Type
Active Comparator
Arm Description
The subject will be treated with the best available therapy, which will include any combination of drugs included in the current protocol of the Ministry of Health and/or complementary notes issued by the Spanish Agency of Medicines and Health Products (AEMPS).
Arm Title
Treatment
Arm Type
Experimental
Arm Description
The subject will be treated with the best available therapy, which will include any combination of drugs included in the current protocol of the Ministry of Health and/or complementary notes issued by the Spanish Agency of Medicines and Health Products (AEMPS) plus Calcifediol caps. 266 µg. According to the pharmacokinetics of Calcifediol evaluated in an inflammatory model, the posology will be Start: 2 capsules Days 3, 7, 14, 21, 28: 1 capsule
Intervention Type
Drug
Intervention Name(s)
BAT + Calcifediol
Intervention Description
The subject will be treated with the best available therapy, which will include any combination of drugs included in the current protocol of the Ministry of Health and/or complementary notes issued by the Spanish Agency of Medicines and Health Products (AEMPS) plus Calcifediol caps. 266 µg. According to the pharmacokinetics of Calcifediol evaluated in an inflammatory model, the posology will be Start: 2 capsules Days 3, 7, 14, 21, 28: 1 capsule
Intervention Type
Drug
Intervention Name(s)
BAT
Intervention Description
The subject will be treated with the best available therapy, which will include any combination of drugs included in the current protocol of the Ministry of Health and/or complementary notes issued by the Spanish Agency of Medicines and Health Products (AEMPS).
Primary Outcome Measure Information:
Title
Admission to Intensive Care Unit
Description
Proportion of subjects who enter the Intensive Care Unit
Time Frame
At day 28.
Title
Death
Description
Proportion of subjects who die.
Time Frame
At day 28.
Secondary Outcome Measure Information:
Title
Time from onset of symptoms to discharge of patients in conventional hospitalization
Description
Compare the time (in days) at discharge in newly hospitalized patients on non-invasive ventilation.
Time Frame
At day 28.
Title
ICU - Time until admission
Description
In patients who, in the course of their evolution, required admission with mechanical ventilation in the ICU, time until admission to Intensive Care Unit
Time Frame
At day 28.
Title
ICU - Time mechanical ventilation is removed
Description
In patients who, in the course of their evolution, required admission with mechanical ventilation in the ICU, time until mechanical ventilation is removed.
Time Frame
At day 28.
Title
Evaluation of the inflammatory markers related with the disease
Description
Evaluation of the inflammatory markers related to IL disease. Blood samples will be collected and assessed in order to evaluate interleukins related with the interleukin storm using immunological tests.
Time Frame
At day 28.
Title
Vitamin D metabolites
Description
Evaluation of the Vitamin D metabolites.
Time Frame
At day 28.
Title
Evolution in SatO2
Description
Compare the evolution in SatO2
Time Frame
At day 28.
Title
Evolution in the Sat O2/FiO2 ratio.
Description
Compare the evolution in the Sat O2/FiO2 ratio
Time Frame
At day 28.
Title
Evolution in the degree of dyspnea
Description
Compare the evolution in the degree of dyspnea using the analog Borg scale
Time Frame
At day 28.
Title
Evolution of the improvement of radiological findings by simple radiology
Description
Compare the evolution of radiological findings by simple radiology in the recruited subjects since their beginning in the trial until they end the trial
Time Frame
At day 28.
Title
Incidence of adverse events
Description
Incidence of adverse events related to medication and its administration.
Time Frame
At day 28.
Title
Appearance of hemorrhagic or thrombotic phenomena
Description
Incidence in the appearance of hemorrhagic or thrombotic phenomena.
Time Frame
At day 28.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 and < 90 years PCR confirmed diagnosis of COVID-19. As an alternative to PCR, a determination of antigens or any other test that in the future is considered equivalent to these in its diagnostic value may be accepted as evidence Radiological image compatible with inflammatory pleuropulmonary exudate or patients with onset of symptoms in the last 7 days and with an uncomplicated respiratory infection for outpatient follow-up. Signature of direct or delegated informed consent Exclusion Criteria: Being treated with Calcifediol or Cholecalciferol in any of its presentations and dosages Intolerance or allergy to Calcifediol or its components Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José López Miranda, MD
Organizational Affiliation
Hospital Universitario Reina Sofía
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Reina Sofía
City
Cordoba
ZIP/Postal Code
14001
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All the information will be published and accessible. It will be also available on demand.
IPD Sharing Time Frame
Since the end publication of the results.
IPD Sharing Access Criteria
Contact uicec@imibic.org
Citations:
PubMed Identifier
34029377
Citation
Stroehlein JK, Wallqvist J, Iannizzi C, Mikolajewska A, Metzendorf MI, Benstoem C, Meybohm P, Becker M, Skoetz N, Stegemann M, Piechotta V. Vitamin D supplementation for the treatment of COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 24;5(5):CD015043. doi: 10.1002/14651858.CD015043.
Results Reference
derived

Learn more about this trial

Prevention and Treatment With Calcifediol of COVID-19 Induced Acute Respiratory Syndrome

We'll reach out to this number within 24 hrs