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

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ClinicalTrials.gov Identifier: NCT04366908
Recruitment Status : Not yet recruiting
First Posted : April 29, 2020
Last Update Posted : April 30, 2020
Sponsor:
Collaborators:
Junta de Andalucía - Consejería de Salud y Familias
Dynamic Solutions
FAES Farma
Information provided by (Responsible Party):
Maimónides Biomedical Research Institute of Córdoba

Tracking Information
First Submitted Date  ICMJE April 25, 2020
First Posted Date  ICMJE April 29, 2020
Last Update Posted Date April 30, 2020
Estimated Study Start Date  ICMJE April 28, 2020
Estimated Primary Completion Date July 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2020)
  • Admission to Intensive Care Unit [ Time Frame: At day 28. ]
    Proportion of subjects who enter the Intensive Care Unit
  • Death [ Time Frame: At day 28. ]
    Proportion of subjects who die.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2020)
  • Time from onset of symptoms to discharge of patients in conventional hospitalization [ Time Frame: At day 28. ]
    Compare the time (in days) at discharge in newly hospitalized patients on non-invasive ventilation.
  • ICU - Time until admission [ Time Frame: At day 28. ]
    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 [ Time Frame: At day 28. ]
    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 [ Time Frame: At day 28. ]
    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 [ Time Frame: At day 28. ]
    Evaluation of the Vitamin D metabolites.
  • Evolution in SatO2 [ Time Frame: At day 28. ]
    Compare the evolution in SatO2
  • Evolution in the Sat O2/FiO2 ratio. [ Time Frame: At day 28. ]
    Compare the evolution in the Sat O2/FiO2 ratio
  • Evolution in the degree of dyspnea [ Time Frame: At day 28. ]
    Compare the evolution in the degree of dyspnea using the analog Borg scale
  • Evolution of the improvement of radiological findings by simple radiology [ Time Frame: At day 28. ]
    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 [ Time Frame: At day 28. ]
    Incidence of adverse events related to medication and its administration.
  • Appearance of hemorrhagic or thrombotic phenomena [ Time Frame: At day 28. ]
    Incidence in the appearance of hemorrhagic or thrombotic phenomena.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2020)
  • Time from onset of symptoms to discharge of patients in conventional hospitalization [ Time Frame: At day 28. ]
    Compare the time (in days) at discharge in newly hospitalized patients on non-invasive ventilation.
  • ICU - Time until admission [ Time Frame: At day 28. ]
    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 [ Time Frame: At day 28. ]
    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 [ Time Frame: At day 28. ]
    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 [ Time Frame: At day 28. ]
    Evaluation of the Vitamin D metabolites.
  • Evolution in SatO2 [ Time Frame: At day 28. ]
    Compare the evolution in SatO2
  • Evolution in the Sat O2/FiO2 ratio. [ Time Frame: At day 28. ]
    Compare the evolution in the Sat O2/FiO2 ratio
  • Evolution in the degree of dyspnea [ Time Frame: At day 28. ]
    Compare the evolution in the degree of dyspnea using the analog Borg scale
  • Evolution of radiological findings [ Time Frame: At day 28. ]
    Compare the evolution of radiological findings by simple radiology
  • Incidence of adverse events [ Time Frame: At day 28. ]
    Incidence of adverse events related to medication and its administration.
  • Appearance of hemorrhagic or thrombotic phenomena [ Time Frame: At day 28. ]
    Incidence in the appearance of hemorrhagic or thrombotic phenomena.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention and Treatment With Calcifediol of COVID-19 Induced Acute Respiratory Syndrome
Official Title  ICMJE Prevention and Treatment With Calcifediol of COVID-19 Coronavirus-induced Acute Respiratory Syndrome (SARS)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • SARS-CoV 2
  • COVID19
  • SARS (Severe Acute Respiratory Syndrome)
  • Cytokine Release Syndrome
  • Cytokine Storm
Intervention  ICMJE
  • Drug: BAT + Calcifediol

    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

  • Drug: BAT
    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).
Study Arms  ICMJE
  • Active Comparator: Control - best available therapy
    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).
    Intervention: Drug: BAT
  • Experimental: Treatment

    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: Drug: BAT + Calcifediol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 27, 2020)
1008
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 28, 2020
Estimated Primary Completion Date July 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 and < 90 years
  • PCR confirmed diagnosis of COVID-19
  • Radiological image compatible with inflammatory pleuropulmonary exudate
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: José Manuel Quesada Gómez, MD 0034671596070 md1qugoj@uco.es
Contact: Antonio Luque, MsC 0034671596070 uicec@imibic.org
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04366908
Other Study ID Numbers  ICMJE COVIDIOL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All the information will be published and accessible. It will be also available on demand.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Since the end publication of the results.
Access Criteria: Contact uicec@imibic.org
Responsible Party Maimónides Biomedical Research Institute of Córdoba
Study Sponsor  ICMJE Maimónides Biomedical Research Institute of Córdoba
Collaborators  ICMJE
  • Junta de Andalucía - Consejería de Salud y Familias
  • Dynamic Solutions
  • FAES Farma
Investigators  ICMJE
Principal Investigator: José López Miranda, MD Hospital Universitario Reina Sofía
PRS Account Maimónides Biomedical Research Institute of Córdoba
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP